Clinical Trials

Temsirolimus (CCI-779) has been evaluated across numerous clinical trials spanning Early Phase I through Phase IV, focusing on oncology indications such as high-grade gliomas, mantle cell lymphoma, advanced endometrial carcinoma, metastatic sarcomas, and refractory solid tumors. Sponsored by academic research centers, government bodies like the National Cancer Institute, and industry partners including Pfizer, these studies encompass both completed and ongoing protocols. Currently, several clinical trials remain active or recruiting to evaluate targeted intra-arterial infusion, combination regimens, and novel drug sensitivity testing.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04199026 RECRUITING
Metastatic Sarcoma; Recurrent Sarcoma; Resectable Sarcoma
M.D. Anderson Cancer Center
2025-02-25
NCT04433572 RECRUITING
Peripheral Artery Disease; Critical Limb Ischemia
Mercator MedSystems, Inc.
2025-07-30 PHASE3
NCT02693535 RECRUITING
Lymphoma, Non-Hodgkin; Multiple Myeloma; Advanced Solid Tumors
American Society of Clinical Oncology
2016-03-14 PHASE2
NCT02389309 ACTIVE_NOT_RECRUITING
Advanced Malignant Solid Neoplasm; Recurrent Brain Neoplasm; Recurrent Malignant Solid Neoplasm; Refractory Brain Neoplasm
M.D. Anderson Cancer Center
2015-10-05 PHASE1
NCT03297606 RECRUITING
Lymphoma, Non-Hodgkin; Multiple Myeloma; Advanced Solid Tumors
Canadian Cancer Trials Group
2018-03-23 PHASE2
NCT01087554 ACTIVE_NOT_RECRUITING
Advanced Cancer
M.D. Anderson Cancer Center
2010-03 PHASE1
NCT03203525 TERMINATED
Advanced Malignant Neoplasm; Colorectal Carcinoma Metastatic in the Liver; Metastatic Malignant Neoplasm in the Liver; Refractory Malignant Neoplasm
M.D. Anderson Cancer Center
2020-06-23 PHASE1
NCT01552434 TERMINATED
Advanced Malignant Neoplasm; Castleman Disease; Digestive System Carcinoma; Erdheim-Chester Disease; Lip and Oral Cavity Carcinoma; Lymphangioleiomyomatosis; Malignant Endocrine Neoplasm; Malignant Female Reproductive System Neoplasm; Malignant Male Reproductive System Neoplasm; Malignant Neoplasm; Malignant Respiratory Tract Neoplasm; Malignant Thoracic Neoplasm; Malignant Urinary System Neoplasm; Mesothelial Neoplasm; Metastatic Malignant Neoplasm; Metastatic Urothelial Carcinoma; Neurofibromatosis Type 2; Recurrent Adult Soft Tissue Sarcoma; Recurrent Breast Carcinoma; Recurrent Childhood Soft Tissue Sarcoma; Recurrent Digestive System Carcinoma; Recurrent Female Reproductive System Carcinoma; Recurrent Male Reproductive System Carcinoma; Recurrent Malignant Neoplasm; Recurrent Pharyngeal Carcinoma; Recurrent Thyroid Gland Carcinoma; Refractory Malignant Neoplasm; Soft Tissue Neoplasm; Stage III Breast Cancer AJCC v7; Stage III Pharyngeal Cancer; Stage IIIA Breast Cancer AJCC v7; Stage IIIB Breast Cancer AJCC v7; Stage IIIC Breast Cancer AJCC v7; Stage IV Breast Cancer AJCC v6 and v7; Stage IV Pharyngeal Cancer; Stage IVA Pharyngeal Cancer; Stage IVB Pharyngeal Cancer; Stage IVC Pharyngeal Cancer; Thyroid Gland Neoplasm
M.D. Anderson Cancer Center
2012-10-16 PHASE1
NCT01187199 ACTIVE_NOT_RECRUITING
Advanced Cancer
M.D. Anderson Cancer Center
2010-08-19 PHASE1
NCT02420613 COMPLETED
Diffuse Intrinsic Pontine Glioma
M.D. Anderson Cancer Center
2015-10-05 PHASE1
NCT01529593 TERMINATED
Advanced Cancers
M.D. Anderson Cancer Center
2012-03-26 PHASE1
NCT05773326 TERMINATED
High Grade Glioma; Glioma; Glioma, Malignant; Glioblastoma
Nader Sanai
2023-05-15 EARLY_PHASE1
NCT02446431 RECRUITING
Solid Tumor
Miller Children's & Women's Hospital Long Beach
2014-07 EARLY_PHASE1
NCT02567435 ACTIVE_NOT_RECRUITING
Alveolar Rhabdomyosarcoma; Botryoid-Type Embryonal Rhabdomyosarcoma; Embryonal Rhabdomyosarcoma; Rhabdomyosarcoma; Sclerosing Rhabdomyosarcoma; Spindle Cell Rhabdomyosarcoma
National Cancer Institute (NCI)
2016-06-01 PHASE3
NCT05773326 Recruiting
High Grade Glioma|Glioma|Glioma Malignant|Glioblastoma
Nader Sanai|Barrow Neurological Institute|Ivy Brain Tumor Center|St. Joseph''s Hospital and Medical Center Phoenix
2023-05-15 Early Phase 1
NCT03158389 COMPLETED
Glioblastoma, Adult
University Hospital Heidelberg
2018-05-07 PHASE1; PHASE2
NCT03571438 UNKNOWN
Kidney Cancer
University Hospital, Grenoble
2017-10-16
NCT01143779 COMPLETED
Advanced Cancer
M.D. Anderson Cancer Center
2010-06 PHASE1
NCT03942601 TERMINATED
Peripheral Arterial Disease
Mercator MedSystems, Inc.
2019-10-01 PHASE2
NCT02908035 UNKNOWN
Chronic Limb Ischemia
Mercator MedSystems, Inc.
2017-03-03 PHASE2
NCT00980460 COMPLETED
PRETEXT I Hepatoblastoma; PRETEXT II Hepatoblastoma; PRETEXT III Hepatoblastoma; PRETEXT IV Hepatoblastoma
National Cancer Institute (NCI)
2009-09-15 PHASE3
NCT01596140 COMPLETED
Advanced Cancer; Solid Tumor
M.D. Anderson Cancer Center
2012-12-18 PHASE1
NCT01614197 COMPLETED
Lymphoblastic Leukemia, Acute, Childhood; Lymphoblastic Lymphoma; Peripheral T-cell Lymphoma
Therapeutic Advances in Childhood Leukemia Consortium
2015-07-03 PHASE1
NCT01392183 COMPLETED
Kidney Cancer
M.D. Anderson Cancer Center
2012-10-24 PHASE2
NCT00761644 COMPLETED
Advanced Cancer
M.D. Anderson Cancer Center
2008-08-21 PHASE1
NCT01051557 COMPLETED
Adult Anaplastic Astrocytoma; Adult Anaplastic Oligodendroglioma; Adult Diffuse Astrocytoma; Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Adult Mixed Glioma; Adult Oligodendroglioma; Recurrent Adult Brain Neoplasm
National Cancer Institute (NCI)
2010-01-27 PHASE1; PHASE2
NCT01517243 COMPLETED
Metastatic Renal Cell Carcinoma
Dartmouth-Hitchcock Medical Center
2010-09-22 PHASE2
NCT01767194 COMPLETED
Ganglioneuroblastoma; Recurrent Neuroblastoma
National Cancer Institute (NCI)
2013-02-12 PHASE2
NCT01375829 ACTIVE_NOT_RECRUITING
Adult Solid Neoplasm
National Cancer Institute (NCI)
2011-06-27 PHASE1
NCT01653067 UNKNOWN
Diffuse Large B-Cell Lymphoma
Mathias Witzens-Harig
2012-09 PHASE2
NCT01016769 COMPLETED
Squamous Cell Cancer; Head and Neck Cancer
Memorial Sloan Kettering Cancer Center
2009-11 PHASE1; PHASE2
NCT01025453 COMPLETED
Thyroid Cancer
Memorial Sloan Kettering Cancer Center
2009-12-01 PHASE2
NCT01076543 COMPLETED
AIDS-Related Hodgkin Lymphoma; Recurrent Adult Hodgkin Lymphoma; Recurrent Follicular Lymphoma; Recurrent Lymphoplasmacytic Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Non-Hodgkin Lymphoma; Recurrent T-Cell Non-Hodgkin Lymphoma; Waldenstrom Macroglobulinemia
National Cancer Institute (NCI)
2010-04-15 PHASE1; PHASE2
NCT00610493 COMPLETED
Advanced Cancer
M.D. Anderson Cancer Center
2008-01-25 PHASE1
NCT02423954 TERMINATED
Advanced Cancer; Pancreatic Cancer; Renal Cell Cancer; Non Small Cell Lung Cancer; Colorectal Carcinoma; Endometrial; Uterine
Western Regional Medical Center
2015-04 PHASE1; PHASE2
NCT02238496 COMPLETED
Brain Tumor, Recurrent; Glioblastoma; Anaplastic Astrocytoma; Anaplastic Oligodendroglioma; Mixed Glioma
Andrew B Lassman, MD
2014-12-08 PHASE1
NCT02343718 COMPLETED
Recurrent Lymphoma; Refractory Lymphoma; Solid Tumours; Central Nervous System
Canadian Cancer Trials Group
2015-06-24 PHASE1
NCT01078142 COMPLETED
Follicular Lymphoma; Mantle Cell Lymphoma
Georg Hess, MD
2010-02-02 PHASE1; PHASE2
NCT02560012 TERMINATED
Carcinoma, Renal Cell
The University of Texas Health Science Center, Houston
2016-01-04 PHASE2
NCT01611116 COMPLETED
Acute Myeloblastic Leukemia
Goethe University
2012-05 PHASE2
NCT01010126 COMPLETED
Adult Hepatocellular Carcinoma; Advanced Adult Hepatocellular Carcinoma; Endometrial Serous Adenocarcinoma; Localized Non-Resectable Adult Liver Carcinoma; Lung Carcinoid Tumor; Malignant Pancreatic Gastrinoma; Malignant Pancreatic Glucagonoma; Malignant Pancreatic Insulinoma; Malignant Pancreatic Somatostatinoma; Metastatic Digestive System Neuroendocrine Tumor G1; Ovarian Carcinosarcoma; Ovarian Endometrioid Adenocarcinoma; Ovarian Seromucinous Carcinoma; Ovarian Serous Surface Papillary Adenocarcinoma; Pancreatic Alpha Cell Adenoma; Pancreatic Beta Cell Adenoma; Pancreatic Delta Cell Adenoma; Pancreatic G-Cell Adenoma; Pancreatic Polypeptide Tumor; Recurrent Adult Liver Carcinoma; Recurrent Digestive System Neuroendocrine Tumor G1; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Pancreatic Neuroendocrine Carcinoma; Recurrent Primary Peritoneal Carcinoma; Recurrent Uterine Corpus Carcinoma; Regional Digestive System Neuroendocrine Tumor G1; Stage IIIA Fallopian Tube Cancer; Stage IIIA Ovarian Cancer; Stage IIIA Primary Peritoneal Cancer; Stage IIIA Uterine Corpus Cancer; Stage IIIB Fallopian Tube Cancer; Stage IIIB Ovarian Cancer; Stage IIIB Primary Peritoneal Cancer; Stage IIIB Uterine Corpus Cancer; Stage IIIC Fallopian Tube Cancer; Stage IIIC Ovarian Cancer; Stage IIIC Primary Peritoneal Cancer; Stage IIIC Uterine Corpus Cancer; Stage IV Fallopian Tube Cancer; Stage IV Ovarian Cancer; Stage IV Primary Peritoneal Cancer; Stage IVA Uterine Corpus Cancer; Stage IVB Uterine Corpus Cancer; Uterine Carcinosarcoma
National Cancer Institute (NCI)
2009-09-08 PHASE2
NCT01049841 COMPLETED
Pediatric Solid Tumors
Memorial Sloan Kettering Cancer Center
2010-01 PHASE1
NCT00729586 COMPLETED
Endometrial Carcinoma; Recurrent Uterine Corpus Carcinoma; Stage IIIA Uterine Corpus Cancer; Stage IIIB Uterine Corpus Cancer; Stage IIIC1 Uterine Corpus Cancer; Stage IIIC2 Uterine Corpus Cancer; Stage IVA Uterine Corpus Cancer; Stage IVB Uterine Corpus Cancer
National Cancer Institute (NCI)
2008-09 PHASE2
NCT01326468 WITHDRAWN
Head and Neck Cancer
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
2011-12-08
NCT00838955 TERMINATED
Hodgkin's Lymphoma
Loyola University
2009-01 PHASE2
NCT01827267 COMPLETED
HER2-mutant Non-Small Cell Lung Cancer
Puma Biotechnology, Inc.
2013-07-01 PHASE2
NCT01111825 COMPLETED
Breast Cancer
Puma Biotechnology, Inc.
2010-04 PHASE1; PHASE2
NCT01535989 COMPLETED
B-cell Lymphoma Refractory
Cristiana Sessa
2011-12 PHASE1
NCT01183663 COMPLETED
Advanced Cancers
M.D. Anderson Cancer Center
2010-08 PHASE1
NCT01687673 COMPLETED
Hepatocellular Carcinoma
University of California, San Francisco
2012-10-05 PHASE2
NCT01251458 COMPLETED
Inoperable HCC
Chinese University of Hong Kong
2009-10 PHASE1; PHASE2
NCT01180049 COMPLETED
Non-Hodgkin's Lymphoma
Pfizer
2011-03 PHASE4
NCT01625156 COMPLETED
Adult Solid Neoplasm
National Cancer Institute (NCI)
2012-05 PHASE1
NCT01946529 COMPLETED
Desmoplastic Small Round Cell Tumor; Ewing Sarcoma of Bone or Soft Tissue; Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
St. Jude Children's Research Hospital
2013-12-27 PHASE2
NCT01174199 TERMINATED
Prostate Cancer; Adenocarcinoma of the Prostate; Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer; Stage IV Prostate Cancer
Roswell Park Cancer Institute
2012-02 PHASE1
NCT01396408 ACTIVE_NOT_RECRUITING
Advanced Rare Tumours
Canadian Cancer Trials Group
2012-02-09 PHASE2
NCT01264341 TERMINATED
Kidney Cancer
Hellenic Cooperative Oncology Group
2010-12 PHASE2
NCT01646021 COMPLETED
Mantle Cell Lymphoma
Janssen Research & Development, LLC
2012-12-10 PHASE3
NCT01222715 COMPLETED
Adult Rhabdomyosarcoma; Childhood Alveolar Rhabdomyosarcoma; Childhood Pleomorphic Rhabdomyosarcoma; Childhood Rhabdomyosarcoma With Mixed Embryonal and Alveolar Features; Previously Treated Childhood Rhabdomyosarcoma; Recurrent Adult Soft Tissue Sarcoma; Recurrent Childhood Rhabdomyosarcoma
National Cancer Institute (NCI)
2010-10 PHASE2
NCT01798446 COMPLETED
Renal Cell Carcinoma; Nonclear Cell; Temsirolimus Resistance
Seoul National University Hospital
2013-02 PHASE2
NCT01460979 COMPLETED
Genital Diseases, Female; Ovarian Diseases; Ovarian Neoplasms; Endometrial Neoplasms
AGO Study Group
2011-10 PHASE2
NCT01369433 TERMINATED
Solid Tumors
AVEO Pharmaceuticals, Inc.
2010-06
NCT00782275 COMPLETED
Renal Cell Carcinoma; Kidney Cancer
Beth Israel Deaconess Medical Center
2009-04 PHASE2
NCT01403415 COMPLETED
Childhood B Acute Lymphoblastic Leukemia; Childhood T Acute Lymphoblastic Leukemia; Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Lymphoblastic Lymphoma
National Cancer Institute (NCI)
2011-09 PHASE1
NCT01902160 COMPLETED
Recurrent Adult Hodgkin Lymphoma
National Cancer Institute (NCI)
2013-09 PHASE1
NCT01206140 COMPLETED
Recurrent Adult Soft Tissue Sarcoma; Stage III Adult Soft Tissue Sarcoma; Stage IV Adult Soft Tissue Sarcoma
National Cancer Institute (NCI)
2010-10 PHASE2
NCT00977574 ACTIVE_NOT_RECRUITING
Endometrial Adenocarcinoma; Endometrial Adenosquamous Carcinoma; Endometrial Clear Cell Adenocarcinoma; Endometrial Serous Adenocarcinoma; Recurrent Malignant Uterine Corpus Neoplasm; Stage IIIA Uterine Corpus Carcinoma or Carcinosarcoma by AJCC v7 Stage; Stage IIIB Uterine Corpus Carcinoma or Carcinosarcoma by AJCC v7 Stage; Stage IIIC Uterine Corpus Carcinoma or Carcinosarcoma by AJCC v7 Stage; Stage IVA Uterine Corpus Carcinoma or Carcinosarcoma by AJCC v7 Stage; Stage IVB Uterine Corpus Carcinoma or Carcinosarcoma by AJCC v7 Stage
National Cancer Institute (NCI)
2009-09-14 PHASE2
NCT01196429 COMPLETED
Ovarian Clear Cell Cystadenocarcinoma; Stage III Ovarian Cancer; Stage IV Ovarian Cancer
National Cancer Institute (NCI)
2010-08 PHASE2
NCT01381692 COMPLETED
Recurrent Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Non-Hodgkin Lymphoma; Recurrent Small Lymphocytic Lymphoma; Recurrent Waldenstrom Macroglobulinemia; Refractory Follicular Lymphoma; Refractory Mantle Cell Lymphoma; Refractory Marginal Zone Lymphoma; Refractory Non-Hodgkin Lymphoma; Refractory Small Lymphocytic Lymphoma
National Cancer Institute (NCI)
2011-07-20 PHASE1; PHASE2
NCT01827943 COMPLETED
Relapsed Bladder Cancer
Institut Bergonié
2009-06 PHASE2
NCT02215720 COMPLETED
Patients With Advanced or Metastatic Solid Tumors
Gustave Roussy, Cancer Campus, Grand Paris
2011-04-26 PHASE1
NCT00770263 COMPLETED
Solid Tumors
Washington University School of Medicine
2009-05 PHASE1
NCT01206036 COMPLETED
Prostatic Neoplasms
Central European Society for Anticancer Drug Research
2010-07 PHASE1; PHASE2
NCT01404104 COMPLETED
Renal Cell Carcinoma
St. Joseph's Healthcare Hamilton
2008-09
NCT01016015 COMPLETED
Metastatic Osteosarcoma; Recurrent Adult Soft Tissue Sarcoma; Recurrent Osteosarcoma; Stage III Adult Soft Tissue Sarcoma; Stage IV Adult Soft Tissue Sarcoma
National Cancer Institute (NCI)
2009-11 PHASE2
NCT01122615 COMPLETED
Renal Cell Cancer; Kidney Cancer
M.D. Anderson Cancer Center
2010-05 PHASE1
NCT01417065 COMPLETED
Advanced Cancer
M.D. Anderson Cancer Center
2010-08 EARLY_PHASE1
NCT00877773 TERMINATED
Advanced Cancers
M.D. Anderson Cancer Center
2009-04 PHASE1; PHASE2
NCT01614301 UNKNOWN
Advanced Melanoma
University of Regensburg
2012-05 PHASE1; PHASE2
NCT01614795 COMPLETED
Childhood Alveolar Soft Part Sarcoma; Childhood Angiosarcoma; Childhood Epithelioid Sarcoma; Childhood Fibrosarcoma; Childhood Gliosarcoma; Childhood Leiomyosarcoma; Childhood Liposarcoma; Childhood Malignant Peripheral Nerve Sheath Tumor; Childhood Synovial Sarcoma; Previously Treated Childhood Rhabdomyosarcoma; Recurrent Childhood Rhabdomyosarcoma; Recurrent Childhood Soft Tissue Sarcoma; Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Recurrent Osteosarcoma; Rhabdomyosarcoma
National Cancer Institute (NCI)
2012-06-18 PHASE2
NCT01529138 COMPLETED
Cancer
Emory University
2011-10 PHASE1
NCT02093598 COMPLETED
Carcinoma, Endometrioid; mTOR Protein
MedSIR
2012-05 PHASE2
NCT00378703 COMPLETED
Clear Cell Renal Cell Carcinoma; Recurrent Renal Cell Carcinoma; Stage IV Renal Cell Cancer AJCC v7
National Cancer Institute (NCI)
2007-09-14 PHASE2
NCT01548482 COMPLETED
Adult Solid Neoplasm; Lung Carcinoid Tumor; Recurrent Digestive System Neuroendocrine Tumor G1; Recurrent Renal Cell Carcinoma; Recurrent Uterine Corpus Sarcoma; Stage III Renal Cell Cancer; Stage IIIB Uterine Sarcoma; Stage IIIC Uterine Sarcoma; Stage IV Renal Cell Cancer; Stage IVA Uterine Sarcoma; Stage IVB Uterine Sarcoma
National Cancer Institute (NCI)
2012-03 PHASE1
NCT01256385 COMPLETED
Recurrent Hypopharyngeal Squamous Cell Carcinoma; Recurrent Laryngeal Squamous Cell Carcinoma; Recurrent Laryngeal Verrucous Carcinoma; Recurrent Lip and Oral Cavity Squamous Cell Carcinoma; Recurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult Primary; Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma; Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma; Recurrent Oral Cavity Verrucous Carcinoma; Recurrent Oropharyngeal Squamous Cell Carcinoma; Recurrent Salivary Gland Carcinoma; Salivary Gland Squamous Cell Carcinoma; Squamous Cell Carcinoma Metastatic in the Neck With Occult Primary; Stage IV Hypopharyngeal Squamous Cell Carcinoma; Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma; Stage IVA Laryngeal Squamous Cell Carcinoma; Stage IVA Laryngeal Verrucous Carcinoma; Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma; Stage IVA Major Salivary Gland Carcinoma; Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma; Stage IVA Oral Cavity Verrucous Carcinoma; Stage IVA Oropharyngeal Squamous Cell Carcinoma; Stage IVB Laryngeal Squamous Cell Carcinoma; Stage IVB Laryngeal Verrucous Carcinoma; Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma; Stage IVB Major Salivary Gland Carcinoma; Stage IVB Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma; Stage IVB Oral Cavity Verrucous Carcinoma; Stage IVB Oropharyngeal Squamous Cell Carcinoma; Stage IVC Laryngeal Squamous Cell Carcinoma; Stage IVC Laryngeal Verrucous Carcinoma; Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma; Stage IVC Major Salivary Gland Carcinoma; Stage IVC Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma; Stage IVC Oral Cavity Verrucous Carcinoma; Stage IVC Oropharyngeal Squamous Cell Carcinoma; Tongue Carcinoma
National Cancer Institute (NCI)
2010-11 PHASE2
NCT01019434 COMPLETED
Brain and Central Nervous System Tumors
European Organisation for Research and Treatment of Cancer - EORTC
2009-10 PHASE2
NCT01335074 WITHDRAWN
Hepatocellular Carcinoma
Philipps University Marburg
2011-04 PHASE1; PHASE2
NCT00942747 UNKNOWN
Recurrent or Refractory Primary CNS Lymphoma
Charite University, Berlin, Germany
2009-07 PHASE2
NCT01141244 COMPLETED
Unspecified Childhood Solid Tumor, Protocol Specific
National Cancer Institute (NCI)
2010-06 PHASE1
NCT01281917 COMPLETED
Non-Hodgkins Lymphoma
University of Wisconsin, Madison
2011-02 PHASE2
NCT00699491 COMPLETED
Male Breast Carcinoma; Recurrent Breast Carcinoma; Stage IV Breast Cancer AJCC v6 and v7
National Cancer Institute (NCI)
2008-10-31 PHASE1; PHASE2
NCT01065662 COMPLETED
Endometrial Cancer; Ovarian Cancer; Cervical Cancer; Fallopian Tube Cancer; Peritoneal Cancer
Susana M. Campos, MD
2010-02 PHASE1
NCT00397982 COMPLETED
Recurrent Melanoma; Stage IIIB Skin Melanoma; Stage IIIC Skin Melanoma; Stage IV Skin Melanoma
National Cancer Institute (NCI)
2008-01 PHASE2
NCT01198184 COMPLETED
Endometrial Papillary Serous Carcinoma; Recurrent Endometrial Carcinoma; Recurrent Renal Cell Cancer; Stage III Endometrial Carcinoma; Stage III Renal Cell Cancer; Stage IV Endometrial Carcinoma; Stage IV Renal Cell Cancer; Unspecified Adult Solid Tumor, Protocol Specific
National Cancer Institute (NCI)
2010-08 PHASE1
NCT00678769 COMPLETED
Malignant Neoplasm
National Cancer Institute (NCI)
2008-05 PHASE1
NCT01111448 TERMINATED
Myelodysplastic Syndrome
Technische Universität Dresden
2010-04 PHASE2
NCT01050985 COMPLETED
Advanced Solid Tumors
Georgetown University
2010-07 PHASE1
NCT00329719 COMPLETED
Adult Glioblastoma; Adult Gliosarcoma; Recurrent Adult Brain Neoplasm
National Cancer Institute (NCI)
2006-03-24 PHASE1; PHASE2
NCT00919035 COMPLETED
Prostate Cancer
Oncology Specialists, S.C.
2009-06 PHASE2
NCT01026623 COMPLETED
Hormone-Resistant Prostate Cancer; Prostate Adenocarcinoma; Recurrent Prostate Carcinoma; Stage IV Prostate Cancer
National Cancer Institute (NCI)
2009-10 PHASE1; PHASE2
NCT01712828 COMPLETED
Healthy
Celgene
2012-10-01 PHASE1
NCT00921310 TERMINATED
Carcinoma, Non-Small-Cell Lung
Washington University School of Medicine
2009-09 PHASE1; PHASE2
NCT01155258 COMPLETED
Extensive Stage Small Cell Lung Cancer; Hereditary Paraganglioma; Male Breast Cancer; Malignant Paraganglioma; Metastatic Gastrointestinal Carcinoid Tumor; Metastatic Pheochromocytoma; Pancreatic Polypeptide Tumor; Recurrent Breast Cancer; Recurrent Cervical Cancer; Recurrent Endometrial Carcinoma; Recurrent Gastrointestinal Carcinoid Tumor; Recurrent Islet Cell Carcinoma; Recurrent Neuroendocrine Carcinoma of the Skin; Recurrent Non-small Cell Lung Cancer; Recurrent Ovarian Epithelial Cancer; Recurrent Ovarian Germ Cell Tumor; Recurrent Pheochromocytoma; Recurrent Prostate Cancer; Recurrent Renal Cell Cancer; Recurrent Small Cell Lung Cancer; Recurrent Uterine Sarcoma; Regional Gastrointestinal Carcinoid Tumor; Regional Pheochromocytoma; Stage III Cervical Cancer; Stage III Endometrial Carcinoma; Stage III Neuroendocrine Carcinoma of the Skin; Stage III Ovarian Epithelial Cancer; Stage III Ovarian Germ Cell Tumor; Stage III Prostate Cancer; Stage III Renal Cell Cancer; Stage III Uterine Sarcoma; Stage IIIA Breast Cancer; Stage IIIA Non-small Cell Lung Cancer; Stage IIIB Breast Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer; Stage IV Endometrial Carcinoma; Stage IV Neuroendocrine Carcinoma of the Skin; Stage IV Non-small Cell Lung Cancer; Stage IV Ovarian Epithelial Cancer; Stage IV Ovarian Germ Cell Tumor; Stage IV Prostate Cancer; Stage IV Renal Cell Cancer; Stage IV Uterine Sarcoma; Stage IVA Cervical Cancer; Stage IVB Cervical Cancer; Thyroid Gland Medullary Carcinoma
University of Southern California
2010-06 PHASE1
NCT01015664 TERMINATED
Squamous Cell Carcinoma of the Head and Neck
University of Tennessee Cancer Institute
2010-02 PHASE1; PHASE2
NCT01567930 UNKNOWN
Unresectable or Metastatic Hepatocellular Carcinoma
University of Tennessee Cancer Institute
2010-02 PHASE2
NCT01204450 TERMINATED
Brain and Central Nervous System Tumors; Neuroblastoma; Sarcoma; Unspecified Childhood Solid Tumor, Protocol Specific
UNC Lineberger Comprehensive Cancer Center
2009-11 PHASE1
NCT00770731 COMPLETED
Advanced Cancer
M.D. Anderson Cancer Center
2008-09 PHASE1
NCT00880282 COMPLETED
Unspecified Childhood Solid Tumor, Protocol Specific
National Cancer Institute (NCI)
2009-04 PHASE1
NCT01008917 COMPLETED
Hepatocellular Carcinoma
University of California, San Francisco
2009-11-17 PHASE1
NCT01653067 Unknown status
Diffuse Large B-Cell Lymphoma
Mathias Witzens-Harig|Johannes Gutenberg University Mainz|Technical University of Munich|Ludwig-Maximilians - University of Munich|University Hospital Ulm|University Hospital Erlangen|Charite University Berlin Germany|University Hospital Freiburg|Johann Wolfgang Goethe University Hospital|University Hospital Heidelberg
2012-09 Phase 2
NCT01009203 TERMINATED
Squamous Cell Carcinoma
New Mexico Cancer Research Alliance
2009-12 PHASE2
NCT00949325 COMPLETED
Sarcoma
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2009-09 PHASE1; PHASE2
NCT01026792 COMPLETED
Cervical Adenocarcinoma; Cervical Adenosquamous Carcinoma; Cervical Squamous Cell Carcinoma; Recurrent Cervical Carcinoma; Stage IIIA Cervical Cancer; Stage IIIB Cervical Cancer; Stage IVA Cervical Cancer; Stage IVB Cervical Cancer
National Cancer Institute (NCI)
2009-12 PHASE2
NCT00887640 TERMINATED
Prostate Cancer
Duke University
2009-07 PHASE2
NCT01246817 UNKNOWN
Renal Cell Cancer
Radboud University Medical Center
2009-08 PHASE2
NCT01281943 WITHDRAWN
Liver Neoplasms
Washington University School of Medicine
2011-06 PHASE2
NCT00979966 COMPLETED
Non-clear Cell Renal Cell Cancer
Central European Society for Anticancer Drug Research
2009-07 PHASE2
NCT00775593 COMPLETED
Leukemia
Gruppo Italiano Malattie EMatologiche dell'Adulto
2008-12 PHASE2
NCT01166126 TERMINATED
Mucosal Melanoma; Recurrent Melanoma; Stage IV Melanoma
National Cancer Institute (NCI)
2010-10 PHASE2
NCT00998036 COMPLETED
Triple Negative Breast Cancer
Columbia University
2009-09 PHASE1
NCT02093598 Completed
Carcinoma Endometrioid|mTOR Protein
MedSIR
2012-05 Phase 2
NCT00909831 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
Abramson Cancer Center at Penn Medicine
2008-10 PHASE1
NCT01182883 WITHDRAWN
Brain Stem Neoplasms; Glioma; Pinealoma
National Cancer Institute (NCI)
2010-07-28 PHASE1
NCT00631371 COMPLETED
Renal Cell Carcinoma
Pfizer
2008-04 PHASE3
NCT01170052 WITHDRAWN
Mantle Cell Lymphoma
Charite University, Berlin, Germany
2010-05 PHASE1; PHASE2
NCT00787969 COMPLETED
Lymphoma
Alliance for Clinical Trials in Oncology
2009-04 PHASE1
NCT01020305 TERMINATED
Prostate Cancer; Prostatic Neoplasms; Castrate-resistant Prostate Cancer (CRPC); Androgen-insensitive Prostate Cancer; Hormone-refractory Prostate Cancer; Metastatic Disease
Sandy Srinivas
2009-10 PHASE1; PHASE2
NCT01061606 TERMINATED
Recurrent Uterine Sarcoma; Uterine Carcinosarcoma
National Cancer Institute (NCI)
2010-01 PHASE2
NCT01172769 COMPLETED
Head and Neck Squamous Cell Carcinoma
Hannover Medical School
2010-06 PHASE2
NCT01378377 TERMINATED
Advanced Solid Tumor
EMD Serono
2011-05-27 PHASE1
NCT01072890 COMPLETED
Solid Tumors
University of California, Davis
2010-02 PHASE1
NCT01851408 WITHDRAWN
Melanoma; Recurrent Melanoma; Stage III Melanoma; Stage IV Melanoma
National Cancer Institute (NCI)
2006-04 PHASE2
NCT00982631 UNKNOWN
Advanced/Recurrent Breast Cancer; Endometrial Cancer; Ovarian Cancer
Radboud University Medical Center
2009-06 PHASE1
NCT00398515 COMPLETED
Refractory Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma
National Cancer Institute (NCI)
2007-03 PHASE1
NCT00619268 COMPLETED
Metastatic Renal Cell Carcinoma
Centre Leon Berard
2008-02 PHASE2
NCT00349206 COMPLETED
Melanoma; Recurrent Melanoma; Stage III Melanoma; Stage IV Melanoma
National Cancer Institute (NCI)
2006-04 PHASE1
NCT00429793 COMPLETED
Fallopian Tube Cancer; Primary Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer
National Cancer Institute (NCI)
2007-02 PHASE2
NCT00408655 COMPLETED
Ovarian Sarcoma; Ovarian Stromal Cancer; Recurrent Endometrial Carcinoma; Recurrent Ovarian Epithelial Cancer; Recurrent Ovarian Germ Cell Tumor; Stage III Endometrial Carcinoma; Stage III Ovarian Epithelial Cancer; Stage III Ovarian Germ Cell Tumor; Stage IV Endometrial Carcinoma; Stage IV Ovarian Epithelial Cancer; Stage IV Ovarian Germ Cell Tumor; Unspecified Adult Solid Tumor, Protocol Specific
National Cancer Institute (NCI)
2007-02 PHASE1
NCT00474786 COMPLETED
Renal Cell Carcinoma
Pfizer
2007-09 PHASE3
NCT01083368 COMPLETED
Prostate Cancer
Case Comprehensive Cancer Center
2009-01 PHASE1; PHASE2
NCT00996346 TERMINATED
Sarcoma
New Mexico Cancer Research Alliance
2009-10 PHASE1
NCT00926107 TERMINATED
Ovarian Cancer
Hellenic Cooperative Oncology Group
2009-06 PHASE2
NCT00723255 COMPLETED
Recurrent Endometrial Carcinoma
National Cancer Institute (NCI)
2008-09 PHASE2
NCT00703170 COMPLETED
Resistant Solid Malignancies
Washington University School of Medicine
2008-03 PHASE1
NCT00838539 COMPLETED
Neoplasms; Malignant Carcinoma
Puma Biotechnology, Inc.
2009-04 PHASE1
NCT00796796 COMPLETED
Carcinoma, Non-Small-Cell Lung
Washington University School of Medicine
2009-03 PHASE1
NCT00703625 COMPLETED
Resistant Solid Malignancies
Washington University School of Medicine
2008-03-08 PHASE1
NCT00494091 COMPLETED
Advanced Renal Cell Carcinoma
Pfizer
2007-02 PHASE2
NCT01079286 COMPLETED
Renal Cell Cancer; Cancer
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
2009-06 PHASE1
NCT00093782 COMPLETED
Metastatic Gastrointestinal Carcinoid Tumor; Pulmonary Carcinoid Tumor; Recurrent Gastrointestinal Carcinoid Tumor; Recurrent Islet Cell Carcinoma
National Cancer Institute (NCI)
2003-12 PHASE2
NCT00827684 COMPLETED
Metastatic Colorectal Cancer
Vejle Hospital
2009-03 PHASE2
NCT00483262 COMPLETED
Multiple Myeloma
Dana-Farber Cancer Institute
2007-05 PHASE1; PHASE2
NCT00281957 COMPLETED
Recurrent Melanoma; Stage IV Melanoma
National Cancer Institute (NCI)
2007-08 PHASE2
NCT01079767 TERMINATED
Liver Cancer
Federation Francophone de Cancerologie Digestive
2010-01 PHASE2
NCT00316849 COMPLETED
Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma
National Cancer Institute (NCI)
2006-05 PHASE1
NCT00784914 COMPLETED
Brain and Central Nervous System Tumors; Metastatic Cancer
City of Hope Medical Center
2008-06 PHASE1
NCT00563147 COMPLETED
Renal Cell Carcinoma
AVEO Pharmaceuticals, Inc.
2007-11 PHASE1
NCT00600496 COMPLETED
Breast Cancer; Breast Neoplasms; Colon Cancer; Colonic Cancer; Colon Neoplasms; Lung Cancer; Melanoma; Kidney Cancer
AstraZeneca
2007-12-14 PHASE1
NCT00693433 COMPLETED
Refractory Multiple Myeloma; Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma
National Cancer Institute (NCI)
2008-12 PHASE1
NCT00112476 COMPLETED
Recurrent Melanoma; Recurrent Renal Cell Cancer; Stage IV Melanoma; Stage IV Renal Cell Cancer; Unspecified Adult Solid Tumor, Protocol Specific
National Cancer Institute (NCI)
2005-03 PHASE1
NCT00101088 TERMINATED
Accelerated Phase Chronic Myelogenous Leukemia; Blastic Phase Chronic Myelogenous Leukemia; Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Chronic Phase Chronic Myelogenous Leukemia; Relapsing Chronic Myelogenous Leukemia
National Cancer Institute (NCI)
2005-04 PHASE1
NCT00949026 WITHDRAWN
Brain Neoplasms
Emory University
2009-07 PHASE1
NCT00112736 COMPLETED
Adult Anaplastic Astrocytoma; Adult Anaplastic Oligodendroglioma; Adult Diffuse Astrocytoma; Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Adult Mixed Glioma; Adult Pilocytic Astrocytoma; Adult Pineal Gland Astrocytoma; Adult Subependymal Giant Cell Astrocytoma; Recurrent Adult Brain Tumor
National Cancer Institute (NCI)
2005-04 PHASE1; PHASE2
NCT00659568 COMPLETED
Breast Cancer; Endometrial Cancer; Kidney Cancer; Lung Cancer; Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific
London Health Sciences Centre
2008-03 PHASE1
NCT00335764 COMPLETED
Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Recurrent Adult Brain Tumor
National Cancer Institute (NCI)
2006-04 PHASE1; PHASE2
NCT00800917 COMPLETED
Glioblastoma Multiforme
Rigshospitalet, Denmark
2008-11 PHASE2
NCT01090466 COMPLETED
Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer
Cardiff University
2008-02 PHASE1; PHASE2
NCT00593008 TERMINATED
Pancreatic Adenocarcinoma
Massachusetts General Hospital
2007-10 PHASE1
NCT00593060 COMPLETED
Colorectal Cancer; Colorectal Adenocarcinoma
Jeffrey W. Clark, MD
2007-11-01 PHASE1
NCT00106353 COMPLETED
Adenocarcinoma; Neoplasms
Pfizer
2005-03 PHASE1; PHASE2
NCT00109967 COMPLETED
Recurrent Mantle Cell Lymphoma
National Cancer Institute (NCI)
2005-05 PHASE2
NCT00523432 COMPLETED
Genital Neoplasms, Female
University of Chicago
2007-08 PHASE1
NCT00808899 TERMINATED
Neuroblastoma
St. Jude Children's Research Hospital
2008-12 PHASE2
NCT00072176 COMPLETED
Endometrial Adenocarcinoma; Endometrial Adenosquamous Cell Carcinoma; Endometrial Clear Cell Carcinoma; Endometrial Papillary Serous Carcinoma; Recurrent Endometrial Carcinoma; Stage IIIA Endometrial Carcinoma; Stage IIIB Endometrial Carcinoma; Stage IIIC Endometrial Carcinoma; Stage IVA Endometrial Carcinoma; Stage IVB Endometrial Carcinoma
National Cancer Institute (NCI)
2004-05 PHASE2
NCT00376688 COMPLETED
Recurrent Breast Carcinoma; Stage III Breast Cancer AJCC v7; Stage IIIA Breast Cancer AJCC v7; Stage IIIB Breast Cancer AJCC v7; Stage IIIC Breast Cancer AJCC v7; Stage IV Breast Cancer AJCC v6 and v7
National Cancer Institute (NCI)
2006-07-11 PHASE2
NCT00275093 COMPLETED
Hepatic Complications; Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific
National Cancer Institute (NCI)
2005-12 PHASE1
NCT00512668 TERMINATED
Adenocarcinoma of the Prostate; Recurrent Prostate Cancer
National Cancer Institute (NCI)
2007-09 PHASE1
NCT00098501 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
National Cancer Institute (NCI)
2004-10 PHASE1
NCT00117598 COMPLETED
Lymphoma
Pfizer
2005-05 PHASE3
NCT00079235 COMPLETED
Recurrent Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer
National Cancer Institute (NCI)
2004-02 PHASE2
NCT00255658 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
National Cancer Institute (NCI)
2005-09 PHASE1
NCT00079456 COMPLETED
Refractory Multiple Myeloma; Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma
National Cancer Institute (NCI)
2004-02 PHASE2
NCT00028028 COMPLETED
Extensive Stage Small Cell Lung Cancer
National Cancer Institute (NCI)
2002-02 PHASE2
NCT00083993 TERMINATED
Breast Neoplasms; Neoplasm Metastasis
Wyeth is now a wholly owned subsidiary of Pfizer
2004-05 PHASE3
NCT00022724 COMPLETED
Brain and Central Nervous System Tumors
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2001-08-27 PHASE1; PHASE2
NCT00071968 COMPLETED
Prostate Cancer
Jonsson Comprehensive Cancer Center
2003-08 PHASE2
NCT00033267 COMPLETED
Recurrent Mantle Cell Lymphoma
National Cancer Institute (NCI)
2002-04 PHASE2
NCT00087074 COMPLETED
Gastrointestinal Stromal Tumor; Recurrent Adult Soft Tissue Sarcoma; Stage I Adult Soft Tissue Sarcoma; Stage II Adult Soft Tissue Sarcoma; Stage III Adult Soft Tissue Sarcoma; Stage IV Adult Soft Tissue Sarcoma
National Cancer Institute (NCI)
2004-06 PHASE2
NCT00022464 COMPLETED
Melanoma (Skin)
City of Hope Medical Center
2001-06 PHASE2
NCT00086840 TERMINATED
Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Hodgkin Lymphoma; Refractory Chronic Lymphocytic Leukemia
National Cancer Institute (NCI)
2004-05 PHASE2
NCT00016328 COMPLETED
Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Recurrent Adult Brain Tumor
National Cancer Institute (NCI)
2001-05 PHASE2
NCT00062751 COMPLETED
Breast Neoplasms
Wyeth is now a wholly owned subsidiary of Pfizer
2002-12 PHASE2
NCT00075647 COMPLETED
Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage II Pancreatic Cancer; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer
National Cancer Institute (NCI)
2003-12 PHASE2
NCT00045370 COMPLETED
Kidney Cancer
Memorial Sloan Kettering Cancer Center
2002-04 PHASE1
NCT00003712 COMPLETED
Brain and Central Nervous System Tumors; Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific
The University of Texas Health Science Center at San Antonio
2001-01 PHASE1
NCT00788580 WITHDRAWN
Unspecified Adult Solid Tumor, Protocol Specific
SWOG Cancer Research Network
PHASE1
NCT00012142 COMPLETED
Prostate Cancer
Jonsson Comprehensive Cancer Center
2000-09 PHASE2
NCT00417677 TERMINATED
Renal Cell Carcinoma
Wyeth is now a wholly owned subsidiary of Pfizer
2007-03 PHASE1; PHASE2
NCT00235794 COMPLETED
Prostatic Neoplasms
Wyeth is now a wholly owned subsidiary of Pfizer
2004-01

(data from https://clinicaltrials.gov, updated on 2026-08-11)

Check the Temsirolimus (CCI-779) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Temsirolimus potently binds to the mammalian target of rapamycin (mTOR), inhibiting downstream biochemical signaling cascades to suppress cell proliferation and induce autophagy and apoptosis. This targeted inhibition of cell survival pathways provides the rationale for its clinical evaluation in halting disease progression in mTOR-driven malignancies, such as high-grade gliomas, endometrial carcinomas, and non-Hodgkin's lymphomas.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.