Clinical Trials

Numerous clinical trials evaluate sunitinib malate across early to late phases for oncology indications—including renal cell carcinoma, gastrointestinal stromal tumors, papillary renal cell carcinoma, non-GIST sarcomas, and pediatric central nervous system tumors—as well as non-oncology conditions such as neovascular age-related macular degeneration. Sponsored by academic centers, government entities such as the National Cancer Institute, and industry sponsors including Pfizer and AstraZeneca, these studies encompass completed, recruiting, active not recruiting, and not yet recruiting statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00329043 ACTIVE_NOT_RECRUITING
Prostate Cancer
M.D. Anderson Cancer Center
2006-05-15 PHASE2
NCT03541902 ACTIVE_NOT_RECRUITING
Malignant Neoplasms of Urinary Tract; Renal Cell Carcinoma; Chromophobe Renal Cell Carcinoma; Metastatic Renal Cell Carcinoma; Papillary Renal Cell Carcinoma; Renal Cell Carcinoma Associated With Xp11.2 Translocations/TFE3 Gene Fusions; Sarcomatoid Renal Cell Carcinoma; Stage IV Renal Cell Cancer AJCC v8; Unclassified Renal Cell Carcinoma
M.D. Anderson Cancer Center
2018-05-15 PHASE2
NCT02068586 ACTIVE_NOT_RECRUITING
Ciliary Body and Choroid Melanoma, Medium/Large Size; Ciliary Body and Choroid Melanoma, Small Size; Iris Melanoma; Stage I Intraocular Melanoma; Stage IIA Intraocular Melanoma; Stage IIB Intraocular Melanoma; Stage IIIA Intraocular Melanoma; Stage IIIB Intraocular Melanoma; Stage IIIC Intraocular Melanoma; Stage I Uveal Melanoma AJCC V7; Stage II Uveal Melanoma AJCC V7; Stage III Uveal Melanoma AJCC V7
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
2014-11-19 PHASE2
NCT02465060 ACTIVE_NOT_RECRUITING
Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Bladder Carcinoma; Breast Carcinoma; Cervical Carcinoma; Colon Carcinoma; Colorectal Carcinoma; Endometrial Carcinoma; Esophageal Carcinoma; Exocrine Pancreas Carcinoma; Gastric Carcinoma; Glioma; Head and Neck Carcinoma; Hematopoietic and Lymphoid Cell Neoplasm; Kidney Carcinoma; Liver Carcinoma; Lung Carcinoma; Lymphoma; Malignant Uterine Corpus Neoplasm; Malignant Uterine Neoplasm; Melanoma; Multiple Myeloma; Ovarian Carcinoma; Prostate Carcinoma; Rectal Carcinoma; Recurrent Bladder Carcinoma; Recurrent Breast Carcinoma; Recurrent Cervical Carcinoma; Recurrent Colon Carcinoma; Recurrent Colorectal Carcinoma; Recurrent Esophageal Carcinoma; Recurrent Gastric Carcinoma; Recurrent Glioma; Recurrent Head and Neck Carcinoma; Recurrent Liver Carcinoma; Recurrent Lung Carcinoma; Recurrent Lymphoma; Recurrent Malignant Solid Neoplasm; Recurrent Malignant Uterine Corpus Neoplasm; Recurrent Melanoma; Recurrent Multiple Myeloma; Recurrent Ovarian Carcinoma; Recurrent Pancreatic Carcinoma; Recurrent Prostate Carcinoma; Recurrent Rectal Carcinoma; Recurrent Skin Carcinoma; Recurrent Thyroid Gland Carcinoma; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma; Skin Carcinoma; Thyroid Gland Carcinoma
National Cancer Institute (NCI)
2015-08-17 PHASE2
NCT05678673 ACTIVE_NOT_RECRUITING
Non-Clear Cell Renal Cell Carcinoma
Exelixis
2023-01-01 PHASE3
NCT05687123 RECRUITING
Metastatic Pancreatic Neuroendocrine Tumor; Pancreatic Neoplasm; Stage III Pancreatic Neuroendocrine Tumor AJCC v8; Stage IV Pancreatic Neuroendocrine Tumor AJCC v8; Unresectable Pancreatic Neuroendocrine Tumor
National Cancer Institute (NCI)
2024-08-14 PHASE1
NCT03463460 ACTIVE_NOT_RECRUITING
Thymic Carcinoma
Dwight Owen
2018-06-19 PHASE2
NCT06222593 Not yet recruiting
Carcinoma Renal Cell
State University of New York at Buffalo
2024-06-01 Phase 1|Phase 2
NCT06208748 Not yet recruiting
Gastrointestinal Stromal Tumors|GIST
Sarcoma Alliance for Research through Collaboration|Cogent Biosciences Inc.|Dana-Farber Cancer Institute|The Life Raft Group
2024-03 Phase 2
NCT02761057 COMPLETED
Locally Advanced Papillary Renal Cell Carcinoma; Metastatic Papillary Renal Cell Carcinoma; Stage III Renal Cell Cancer AJCC v7; Stage IV Renal Cell Cancer AJCC v7; Type 1 Papillary Renal Cell Carcinoma; Type 2 Papillary Renal Cell Carcinoma; Unresectable Renal Cell Carcinoma
National Cancer Institute (NCI)
2016-07-25 PHASE2
NCT00813423 COMPLETED
Adult Solid Neoplasm
National Cancer Institute (NCI)
2010-02-19 PHASE1
NCT05745142 Completed
Carcinoma Renal Cell|Clear-cell Metastatic Renal Cell Carcinoma
Pfizer
2023-02-23 --
NCT05043090 Recruiting
Papillary Renal Cell Carcinoma
AstraZeneca
2021-10-28 Phase 3
NCT03909724 UNKNOWN
Colorectal Cancer; Metastasis
Amsterdam UMC, location VUmc
2019-10-01 PHASE2; PHASE3
NCT04669366 Completed
Kidney Neoplasms
Pfizer
2021-01-20 --
NCT03953079 COMPLETED
Neovascular Age-Related Macular Degeneration
Graybug Vision
2019-09-26 PHASE2
NCT01664182 COMPLETED
Advanced Renal Cell Carcinoma; Advanced Sarcomatoid Renal Cell Carcinoma; Stage III Renal Cell Cancer AJCC v7; Stage IV Renal Cell Cancer AJCC v7
National Cancer Institute (NCI)
2012-08-01 PHASE2
NCT04085341 COMPLETED
Diabetic Macular Edema; Retina Vein Occlusion
Graybug Vision
2019-09-11 PHASE2
NCT00478426 COMPLETED
Endometrial Adenocarcinoma; Endometrial Endometrioid Adenocarcinoma; Endometrial Serous Adenocarcinoma; Recurrent Uterine Corpus Carcinoma; Stage IVA Uterine Corpus Cancer AJCC v7; Stage IVB Uterine Corpus Cancer AJCC v7; Uterine Carcinosarcoma; Uterine Corpus Carcinosarcoma
National Cancer Institute (NCI)
2007-04-30 PHASE2
NCT05800106 COMPLETED
Gastrointestinal Stromal Tumors; Renal Cell Carcinoma; Pancreatic Neuroendocrine Tumor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
2018-12-04 PHASE1
NCT03249740 COMPLETED
Neovascular Age-Related Macular Degeneration
Graybug Vision
2017-08-29 PHASE1
NCT02779283 COMPLETED
Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia
OHSU Knight Cancer Institute
2016-01-13 PHASE1
NCT01005472 COMPLETED
Metastatic Melanoma
Jonsson Comprehensive Cancer Center
2008-12-01 PHASE1
NCT02626754 TERMINATED
Renal Cell Carcinoma
vghtpe user
2015-08-12 PHASE2
NCT01396148 COMPLETED
Gastrointestinal Stromal Tumors
Pfizer
2012-06 PHASE2
NCT01164202 COMPLETED
Liver Cancer
Federation Francophone de Cancerologie Digestive
2010-07 PHASE2; PHASE3
NCT01620216 TERMINATED
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia; Recurrent Acute Lymphoblastic Leukemia; Recurrent Acute Myeloid Leukemia; Refractory Acute Lymphoblastic Leukemia; Refractory Acute Myeloid Leukemia
OHSU Knight Cancer Institute
2012-05-11 PHASE2
NCT00381641 COMPLETED
Differentiated Thyroid Gland Carcinoma; Recurrent Thyroid Gland Carcinoma; Refractory Thyroid Gland Carcinoma; Stage III Thyroid Gland Follicular Carcinoma AJCC v7; Stage III Thyroid Gland Medullary Carcinoma AJCC v7; Stage IV Thyroid Gland Follicular Carcinoma AJCC v7; Stage IV Thyroid Gland Medullary Carcinoma AJCC v7; Stage IV Thyroid Gland Papillary Carcinoma AJCC v7; Stage IVA Thyroid Gland Follicular Carcinoma AJCC v7; Stage IVA Thyroid Gland Medullary Carcinoma AJCC v7; Stage IVA Thyroid Gland Papillary Carcinoma AJCC v7; Stage IVB Thyroid Gland Follicular Carcinoma AJCC v7; Stage IVB Thyroid Gland Medullary Carcinoma AJCC v7; Stage IVB Thyroid Gland Papillary Carcinoma AJCC v7; Stage IVC Thyroid Gland Follicular Carcinoma AJCC v7; Stage IVC Thyroid Gland Medullary Carcinoma AJCC v7; Stage IVC Thyroid Gland Papillary Carcinoma AJCC v7; Thyroid Gland Oncocytic Carcinoma; Unresectable Thyroid Gland Carcinoma
National Cancer Institute (NCI)
2006-08-29 PHASE2
NCT01835158 COMPLETED
Clear Cell Renal Cell Carcinoma; Metastatic Kidney Carcinoma; Stage III Renal Cell Cancer AJCC v7; Stage IV Renal Cell Cancer AJCC v7
National Cancer Institute (NCI)
2013-07-08 PHASE2
NCT00375674 COMPLETED
Kidney Neoplasms
Pfizer
2007-08-01 PHASE3
NCT01525550 COMPLETED
Well-differentiated Pancreatic Neuroendocrine Tumor
Pfizer
2012-06-06 PHASE4
NCT01061411 COMPLETED
Clear Cell Sarcoma of the Kidney; Recurrent Renal Cell Carcinoma; Stage III Renal Cell Cancer; Stage IV Renal Cell Cancer
Roswell Park Cancer Institute
2010-02-06 PHASE1
NCT00326898 COMPLETED
Clear Cell Renal Cell Carcinoma; Stage I Renal Cell Cancer AJCC v6 and v7; Stage II Renal Cell Cancer AJCC v7; Stage III Renal Cell Cancer AJCC v7
National Cancer Institute (NCI)
2006-04-24 PHASE3
NCT00519896 COMPLETED
Recurrent Thyroid Cancer; Stage IVA Follicular Thyroid Cancer; Stage IVA Papillary Thyroid Cancer; Stage IVB Follicular Thyroid Cancer; Stage IVB Papillary Thyroid Cancer; Stage IVC Follicular Thyroid Cancer; Stage IVC Papillary Thyroid Cancer; Thyroid Gland Medullary Carcinoma
University of Washington
2007-07 PHASE2
NCT00465179 COMPLETED
Renal Cell Cancer; Kidney Cancer
M.D. Anderson Cancer Center
2007-03 PHASE2
NCT00631527 COMPLETED
Prostate Cancer
M.D. Anderson Cancer Center
2008-02 PHASE1
NCT00912912 TERMINATED
Genitourinary Disease
M.D. Anderson Cancer Center
2009-05 PHASE2
NCT00943839 COMPLETED
Kidney Cancer
Centre Antoine Lacassagne
2009-02
NCT01089088 COMPLETED
Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer
Cardiff University
2009-04 PHASE2
NCT00428220 COMPLETED
Metastatic Breast Cancer; Advanced Breast Cancer; Metastatic Castration Resistant Prostate Cancer; Metastatic Renal Cell Cancer; Non-Small Cell Lung Cancer; Thyroid Cancer; Advanced/Metastatic Non-Small Cell Lung Cancer; Advanced Gastric Cancer; Gastrointestinal Stromal Tumor; Hepatocellular Carcinoma; Pancreatic Islet Cell Carcinoma; Pancreatic Neuroendocrine Tumor
Pfizer
2007-07
NCT00463060 COMPLETED
Cancer
Icahn School of Medicine at Mount Sinai
2007-01 PHASE1; PHASE2
NCT00747305 TERMINATED
Kidney Cancer
Harry Drabkin
2008-10 PHASE1
NCT00499135 COMPLETED
Adult Solid Neoplasm; Clear Cell Renal Cell Carcinoma; Recurrent Renal Cell Carcinoma; Stage III Renal Cell Cancer; Stage IV Renal Cell Cancer
National Cancer Institute (NCI)
2007-05-22 PHASE1
NCT00979992 COMPLETED
Ovarian Clear Cell Adenocarcinoma; Recurrent Ovarian Carcinoma
National Cancer Institute (NCI)
2010-04-19 PHASE2
NCT00793871 COMPLETED
Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors
Pfizer
2008-11 PHASE4
NCT01740154 TERMINATED
Fatigue; Recurrent Renal Cell Cancer; Stage IV Renal Cell Cancer
Case Comprehensive Cancer Center
2012-09
NCT00853125 TERMINATED
Kidney Cancer
Rutgers, The State University of New Jersey
2009-02 PHASE2
NCT01243359 COMPLETED
Clear Cell Renal Cell Carcinoma; Recurrent Renal Cell Cancer; Stage I Renal Cell Cancer; Stage II Renal Cell Cancer; Stage III Renal Cell Cancer; Stage IV Renal Cell Cancer; Unspecified Adult Solid Tumor, Protocol Specific
National Cancer Institute (NCI)
2010-10 PHASE1
NCT01462695 COMPLETED
Childhood Cerebellar Anaplastic Astrocytoma; Childhood Cerebral Anaplastic Astrocytoma; Childhood Cerebral Astrocytoma; Childhood Infratentorial Ependymoma; Childhood Mixed Glioma; Childhood Oligodendroglioma; Childhood Supratentorial Ependymoma; Recurrent Childhood Cerebellar Astrocytoma; Recurrent Childhood Cerebral Astrocytoma; Recurrent Childhood Ependymoma; Recurrent Childhood Subependymal Giant Cell Astrocytoma
National Cancer Institute (NCI)
2012-01 PHASE2
NCT00693992 COMPLETED
Stage IIIB Lung Non-Small Cell Cancer AJCC v7; Stage IV Non-Small Cell Lung Cancer AJCC v7
National Cancer Institute (NCI)
2008-06-15 PHASE3
NCT00702884 COMPLETED
Esophageal Cancer
Tony Bekaii-Saab
2008-06-30 PHASE2
NCT00524186 TERMINATED
Esophageal Cancer; Gastric Cancer
Roswell Park Cancer Institute
2007-05 PHASE1
NCT00453154 COMPLETED
Extensive Stage Lung Small Cell Carcinoma; Recurrent Lung Small Cell Carcinoma
National Cancer Institute (NCI)
2007-03-15 PHASE1; PHASE2
NCT01158222 COMPLETED
Clear Cell Renal Cell Carcinoma; Stage IV Renal Cell Cancer
Case Comprehensive Cancer Center
2010-08-18 PHASE2
NCT00891878 COMPLETED
Adenocarcinoma of the Gastroesophageal Junction; Esophageal Cancer
Alliance for Clinical Trials in Oncology
2009-08 PHASE2
NCT00489944 UNKNOWN
Intraocular Melanoma
San Diego Pacific Oncology & Hematology Associates
2007-05 PHASE2
NCT00387920 COMPLETED
Central Nervous System Metastases; Childhood Central Nervous System Choriocarcinoma; Childhood Central Nervous System Embryonal Tumor; Childhood Central Nervous System Germ Cell Tumor; Childhood Central Nervous System Germinoma; Childhood Central Nervous System Mixed Germ Cell Tumor; Childhood Central Nervous System Teratoma; Childhood Central Nervous System Yolk Sac Tumor; Recurrent Childhood Central Nervous System Embryonal Tumor; Unspecified Childhood Solid Tumor, Protocol Specific
National Cancer Institute (NCI)
2006-10 PHASE1
NCT00672594 COMPLETED
Prostate Cancer; Prostatectomy
Duke University
2006-07 PHASE2
NCT00906360 TERMINATED
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma; Recurrent Metastatic Squamous Neck Cancer With Occult Primary; Recurrent Salivary Gland Cancer; Recurrent Squamous Cell Carcinoma of the Hypopharynx; Recurrent Squamous Cell Carcinoma of the Larynx; Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity; Recurrent Squamous Cell Carcinoma of the Nasopharynx; Recurrent Squamous Cell Carcinoma of the Oropharynx; Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Recurrent Verrucous Carcinoma of the Larynx; Recurrent Verrucous Carcinoma of the Oral Cavity; Salivary Gland Squamous Cell Carcinoma; Stage III Salivary Gland Cancer; Stage III Squamous Cell Carcinoma of the Hypopharynx; Stage III Squamous Cell Carcinoma of the Larynx; Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage III Squamous Cell Carcinoma of the Nasopharynx; Stage III Squamous Cell Carcinoma of the Oropharynx; Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage III Verrucous Carcinoma of the Larynx; Stage III Verrucous Carcinoma of the Oral Cavity; Stage IV Salivary Gland Cancer; Stage IV Squamous Cell Carcinoma of the Hypopharynx; Stage IV Squamous Cell Carcinoma of the Larynx; Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IV Squamous Cell Carcinoma of the Nasopharynx; Stage IV Squamous Cell Carcinoma of the Oropharynx; Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IV Verrucous Carcinoma of the Larynx; Stage IV Verrucous Carcinoma of the Oral Cavity; Tongue Cancer; Untreated Metastatic Squamous Neck Cancer With Occult Primary
National Cancer Institute (NCI)
2008-07 PHASE1
NCT00606008 COMPLETED
Anaplastic Astrocytoma; Glioblastoma
H. Lee Moffitt Cancer Center and Research Institute
2007-03 PHASE2
NCT00513695 COMPLETED
Inflammatory Breast Cancer; Male Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer
University of Washington
2007-06 PHASE2
NCT00864721 COMPLETED
Non Small Cell Lung Cancer
US Oncology Research
2009-02 PHASE2
NCT00357318 COMPLETED
Unspecified Adult Solid Tumor, Protocol Specific
National Cancer Institute (NCI)
2006-06 PHASE1
NCT01118351 TERMINATED
Recurrent Bladder Cancer; Transitional Cell Carcinoma of the Bladder
Case Comprehensive Cancer Center
2008-10 PHASE2
NCT00753727 UNKNOWN
Soft Tissue Sarcoma
Australasian Sarcoma Study Group
2008-09 PHASE1; PHASE2
NCT01258348 COMPLETED
Metastatic Renal Cell Cancer
Eli Lilly and Company
2008-07 PHASE1
NCT00397488 COMPLETED
Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer
Memorial Sloan Kettering Cancer Center
2006-09 PHASE2
NCT00434109 COMPLETED
Neuroendocrine Tumor; Islet Cell Tumor
H. Lee Moffitt Cancer Center and Research Institute
2006-11 PHASE2
NCT00910039 TERMINATED
Cognitive/Functional Effects; Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific
Case Comprehensive Cancer Center
2009-04 PHASE2
NCT00392496 COMPLETED
Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Stage IV Adult Diffuse Large Cell Lymphoma
National Cancer Institute (NCI)
2007-02 PHASE2
NCT00388037 COMPLETED
Recurrent Fallopian Tube Cancer; Recurrent Ovarian Epithelial Cancer; Recurrent Primary Peritoneal Cavity Cancer; Stage IIIA Fallopian Tube Cancer; Stage IIIA Ovarian Epithelial Cancer; Stage IIIA Primary Peritoneal Cavity Cancer; Stage IIIB Fallopian Tube Cancer; Stage IIIB Ovarian Epithelial Cancer; Stage IIIB Primary Peritoneal Cavity Cancer; Stage IIIC Fallopian Tube Cancer; Stage IIIC Ovarian Epithelial Cancer; Stage IIIC Primary Peritoneal Cavity Cancer; Stage IV Fallopian Tube Cancer; Stage IV Ovarian Epithelial Cancer; Stage IV Primary Peritoneal Cavity Cancer
National Cancer Institute (NCI)
2007-01 PHASE2
NCT00392444 COMPLETED
Advanced Malignant Mesothelioma; Recurrent Malignant Mesothelioma
National Cancer Institute (NCI)
2007-02 PHASE2
NCT00698815 COMPLETED
Recurrent Non-Small Cell Lung Carcinoma; Stage IIIB Non-Small Cell Lung Cancer AJCC v7; Stage IV Non-Small Cell Lung Cancer AJCC v7
National Cancer Institute (NCI)
2008-04-15 PHASE2
NCT00400569 COMPLETED
Liposarcoma; Leiomyosarcoma; Fibrosarcoma; Malignant Fibrous Histiocytoma
H. Lee Moffitt Cancer Center and Research Institute
2006-11 PHASE2
NCT00699374 TERMINATED
Carcinoma, Hepatocellular
Pfizer
2008-07 PHASE3
NCT00480935 TERMINATED
Renal Cell Carcinoma
University Health Network, Toronto
2007-10 PHASE2
NCT00931450 UNKNOWN
Breast Cancer
Institut Català d'Oncologia
2009-03 PHASE1; PHASE2
NCT00879619 TERMINATED
Prostate Cancer; Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage III Prostate Cancer; Stage IV Prostate Cancer
John P. Fruehauf
2009-07 PHASE1; PHASE2
NCT00451048 COMPLETED
Chronic Myelomonocytic Leukemia; de Novo Myelodysplastic Syndromes; Myelodysplastic Syndromes; Secondary Myelodysplastic Syndromes
National Cancer Institute (NCI)
2007-02 PHASE2
NCT00853372 COMPLETED
Advanced Renal Cell Carcinoma
Amgen
2009-05-28 PHASE2
NCT00706706 COMPLETED
Carcinoma, Renal Cell
Pfizer
2008-07 PHASE4
NCT00520533 TERMINATED
Renal Cell Carcinoma (RCC)
Ludwig Institute for Cancer Research
2008-02 PHASE1
NCT00792025 COMPLETED
Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter
Institut Curie
2008-12 PHASE2
NCT00330564 TERMINATED
Von Hippel-Lindau Syndrome; Renal Cell Carcinoma; Hemangioblastoma
M.D. Anderson Cancer Center
2006-05 PHASE2
NCT00890747 COMPLETED
Accelerated Phase Chronic Myelogenous Leukemia; Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome; Acute Undifferentiated Leukemia; Adult Acute Lymphoblastic Leukemia in Remission; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Grade III Lymphomatoid Granulomatosis; Adult Langerhans Cell Histiocytosis; Adult Nasal Type Extranodal NK/T-cell Lymphoma; Aggressive NK-cell Leukemia; AIDS-related Diffuse Large Cell Lymphoma; AIDS-related Diffuse Mixed Cell Lymphoma; AIDS-related Diffuse Small Cleaved Cell Lymphoma; AIDS-related Immunoblastic Large Cell Lymphoma; AIDS-related Lymphoblastic Lymphoma; AIDS-related Malignancies; AIDS-related Small Noncleaved Cell Lymphoma; Anaplastic Large Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative; Chronic Eosinophilic Leukemia; Chronic Myelomonocytic Leukemia; Chronic Neutrophilic Leukemia; Chronic Phase Chronic Myelogenous Leukemia; Clear Cell Renal Cell Carcinoma; Cutaneous B-cell Non-Hodgkin Lymphoma; de Novo Myelodysplastic Syndromes; Essential Thrombocythemia; Extramedullary Plasmacytoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Hepatosplenic T-cell Lymphoma; HIV Infection; HIV-associated Hodgkin Lymphoma; Intraocular Lymphoma; Isolated Plasmacytoma of Bone; Light Chain Deposition Disease; Mast Cell Leukemia; Myelodysplastic Syndrome With Isolated Del(5q); Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Myeloid/NK-cell Acute Leukemia; Nodal Marginal Zone B-cell Lymphoma; Noncutaneous Extranodal Lymphoma; Osteolytic Lesions of Multiple Myeloma; Peripheral T-cell Lymphoma; Plasma Cell Neoplasm; Polycythemia Vera; Post-transplant Lymphoproliferative Disorder; Previously Treated Myelodysplastic Syndromes; Primary Myelofibrosis; Primary Systemic Amyloidosis; Progressive Hairy Cell Leukemia, Initial Treatment; Prolymphocytic Leukemia; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Acute Myeloid Leukemia; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Grade III Lymphomatoid Granulomatosis; Recurrent Adult Hodgkin Lymphoma; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Adult T-cell Leukemia/Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Recurrent Renal Cell Cancer; Recurrent Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia; Refractory Hairy Cell Leukemia; Refractory Multiple Myeloma; Relapsing Chronic Myelogenous Leukemia; Stage IV Renal Cell Cancer; T-cell Large Granular Lymphocyte Leukemia; Testicular Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific; Waldenström Macroglobulinemia
National Cancer Institute (NCI)
2009-08 PHASE1
NCT00859339 TERMINATED
Transitional Cell Carcinoma of the Bladder
Noah Hahn, M.D.
2009-03 PHASE2
NCT00616122 TERMINATED
Breast Cancer
University of California, San Francisco
2006-03-01 PHASE1; PHASE2
NCT00459979 COMPLETED
Kidney Cancer
Case Comprehensive Cancer Center
2007-03 PHASE2
NCT00541008 COMPLETED
Kidney Cancer
UNICANCER
2007-09-05 PHASE2
NCT00673816 TERMINATED
Von Hippel-Lindau Syndrome
National Eye Institute (NEI)
2008-05 PHASE1; PHASE2
NCT00626509 UNKNOWN
Kidney Cancer
Gruppo Italiano Carcinoma Renale
2008-02 PHASE2
NCT00814021 COMPLETED
Kidney Cancer; Metastatic Cancer
Institut Claudius Regaud
2009-04 PHASE2
NCT01118039 UNKNOWN
Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer
Hospital del Mar
2006-07 PHASE2
NCT00524316 TERMINATED
Liver Cancer
Roswell Park Cancer Institute
2007-04 PHASE2
NCT00495625 TERMINATED
Liver Cancer
H. Lee Moffitt Cancer Center and Research Institute
2006-10 PHASE2
NCT00824538 TERMINATED
Breast Cancer
University of California, San Francisco
2009-02 PHASE2
NCT00459875 COMPLETED
Kidney Cancer
Memorial Sloan Kettering Cancer Center
2007-03 PHASE2
NCT00474994 COMPLETED
Adult Malignant Fibrous Histiocytoma of Bone; Desmoid Tumor; Endometrial Cancer; Ovarian Cancer; Sarcoma; Small Intestine Cancer
Memorial Sloan Kettering Cancer Center
2007-04 PHASE2
NCT00521092 WITHDRAWN
AIDS-related Kaposi Sarcoma; Classic Kaposi Sarcoma
National Cancer Institute (NCI)
2009-01 PHASE2
NCT00656669 COMPLETED
Breast Cancer
Indiana University
2008-04
NCT00555620 COMPLETED
Stomach Neoplasms
Pfizer
2008-05 PHASE1
NCT00425386 COMPLETED
Kidney Cancer
OHSU Knight Cancer Institute
2006-08 PHASE2
NCT01024205 COMPLETED
Kidney Cancer
Barts and the London School of Medicine and Dentistry
2007-08 PHASE2
NCT00717587 UNKNOWN
Kidney Cancer
Abramson Cancer Center at Penn Medicine
2008-06 PHASE2
NCT00953459 TERMINATED
Lung Cancer
European Organisation for Research and Treatment of Cancer - EORTC
2009-02 PHASE2
NCT00471276 COMPLETED
Breast Neoplasms
Pfizer
2007-08 PHASE2
NCT00267748 COMPLETED
Carcinoma, Renal Cell
Pfizer
2005-12 PHASE2
NCT00462553 COMPLETED
Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific
National Cancer Institute (NCI)
2007-03 PHASE1
NCT00787787 TERMINATED
Adult Primary Hepatocellular Carcinoma; Advanced Adult Primary Liver Cancer; Localized Unresectable Adult Primary Liver Cancer; Recurrent Adult Primary Liver Cancer
University of Washington
2008-09 PHASE2
NCT00936832 WITHDRAWN
Colorectal Cancer; Metastatic Cancer
Federation Francophone de Cancerologie Digestive
2009-04 PHASE2
NCT00482755 COMPLETED
Breast Cancer
NCIC Clinical Trials Group
2009-04-08 PHASE2
NCT00387335 COMPLETED
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma; Recurrent Metastatic Squamous Neck Cancer With Occult Primary; Recurrent Squamous Cell Carcinoma of the Hypopharynx; Recurrent Squamous Cell Carcinoma of the Larynx; Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity; Recurrent Squamous Cell Carcinoma of the Nasopharynx; Recurrent Squamous Cell Carcinoma of the Oropharynx; Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IV Squamous Cell Carcinoma of the Hypopharynx; Stage IV Squamous Cell Carcinoma of the Larynx; Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IV Squamous Cell Carcinoma of the Nasopharynx; Stage IV Squamous Cell Carcinoma of the Oropharynx; Stage IV Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity
National Cancer Institute (NCI)
2006-08 PHASE2
NCT00730353 COMPLETED
Esophageal Cancer
Hoosier Cancer Research Network
2008-08 PHASE2
NCT00526656 COMPLETED
Bladder Cancer
Case Comprehensive Cancer Center
2007-09 PHASE2
NCT00393939 COMPLETED
Breast Neoplasms
Pfizer
2007-02 PHASE3
NCT00555672 COMPLETED
Stomach Neoplasms
Pfizer
2008-08 PHASE1
NCT00662025 COMPLETED
Advanced/Metastatic Breast Cancer
Pfizer
2008-04 PHASE2
NCT00372567 TERMINATED
Gastrointestinal Stromal Tumor
Pfizer
2007-06 PHASE3
NCT00373113 TERMINATED
Breast Neoplasms
Pfizer
2006-11 PHASE3
NCT00573404 TERMINATED
Gastrointestinal Stromal Tumor
Vanderbilt-Ingram Cancer Center
2007-07 PHASE1
NCT00849186 COMPLETED
Kidney Cancer
Roswell Park Cancer Institute
2007-08
NCT00417885 TERMINATED
Breast Neoplasms
Pfizer
2007-06 PHASE1; PHASE2
NCT00411151 COMPLETED
Gastric Adenocarcinoma; Barrett Esophagus
Johannes Gutenberg University Mainz
2006-12 PHASE2
NCT00599313 COMPLETED
Metastatic Prostate Cancer
US Oncology Research
2007-03 PHASE2
NCT00499473 COMPLETED
Adult Anaplastic Astrocytoma; Adult Diffuse Astrocytoma; Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Adult Mixed Glioma; Adult Oligodendroglioma; Adult Pineal Gland Astrocytoma
National Cancer Institute (NCI)
2007-06 PHASE2
NCT00338884 COMPLETED
Carcinoma, Renal Cell
Pfizer
2006-09 PHASE2
NCT00482911 TERMINATED
Intraocular Melanoma; Malignant Conjunctival Neoplasm
National Institutes of Health Clinical Center (CC)
2007-04 PHASE2
NCT00428597 TERMINATED
Carcinoma, Islet Cell; Carcinoma, Pancreas
Pfizer
2007-06 PHASE3
NCT00514137 COMPLETED
Refractory Multiple Myeloma; Stage I Multiple Myeloma; Stage II Multiple Myeloma; Stage III Multiple Myeloma
National Cancer Institute (NCI)
2007-09 PHASE2
NCT00389974 COMPLETED
Cervical Adenocarcinoma; Cervical Adenosquamous Cell Carcinoma; Cervical Squamous Cell Carcinoma; Recurrent Cervical Cancer; Stage IVB Cervical Cancer
National Cancer Institute (NCI)
2007-01 PHASE2
NCT00387426 TERMINATED
Accelerated Phase Chronic Myelogenous Leukemia; Acute Undifferentiated Leukemia; Adult Acute Lymphoblastic Leukemia in Remission; Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative; Blastic Phase Chronic Myelogenous Leukemia; Chronic Myelomonocytic Leukemia; Chronic Phase Chronic Myelogenous Leukemia; Mast Cell Leukemia; Meningeal Chronic Myelogenous Leukemia; Primary Myelofibrosis; Progressive Hairy Cell Leukemia, Initial Treatment; Prolymphocytic Leukemia; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Acute Myeloid Leukemia; Refractory Chronic Lymphocytic Leukemia; Refractory Hairy Cell Leukemia; Relapsing Chronic Myelogenous Leukemia; Secondary Acute Myeloid Leukemia; Stage I Chronic Lymphocytic Leukemia; Stage II Chronic Lymphocytic Leukemia; Stage III Chronic Lymphocytic Leukemia; Stage IV Chronic Lymphocytic Leukemia; T-cell Large Granular Lymphocyte Leukemia; Untreated Adult Acute Lymphoblastic Leukemia; Untreated Adult Acute Myeloid Leukemia; Untreated Hairy Cell Leukemia
National Cancer Institute (NCI)
2006-09 PHASE2
NCT00399152 COMPLETED
Renal Cancer; GIST
AEterna Zentaris
2006-10 PHASE1
NCT00444314 COMPLETED
Metastatic Renal Cell Carcinoma
CASI pharmaceuticals, Inc.
2007-02 PHASE2
NCT00398112 COMPLETED
B-cell Chronic Lymphocytic Leukemia; Recurrent Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia
National Cancer Institute (NCI)
2007-08 PHASE2
NCT00453310 COMPLETED
Extragonadal Germ Cell Tumor; Ovarian Cancer; Teratoma; Testicular Germ Cell Tumor
Memorial Sloan Kettering Cancer Center
2007-03 PHASE2
NCT00462982 COMPLETED
Kidney Cancer; Melanoma (Skin); Metastatic Cancer
Memorial Sloan Kettering Cancer Center
2007-03 PHASE2
NCT00457743 COMPLETED
Gastrointestinal Stromal Tumors
Pfizer
2005-01 PHASE1; PHASE2
NCT00514228 COMPLETED
Liver Cancer
Swiss Cancer Institute
2007-07 PHASE2
NCT00748163 WITHDRAWN
Lung Cancer
Masonic Cancer Center, University of Minnesota
2008-08 PHASE2
NCT00402415 TERMINATED
Tumors
Yale University
2006-02 PHASE1
NCT00397787 COMPLETED
Acinar Cell Adenocarcinoma of the Pancreas; Duct Cell Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage IV Pancreatic Cancer
National Cancer Institute (NCI)
2006-11 PHASE2
NCT00378911 COMPLETED
Recurrent Uterine Sarcoma; Uterine Leiomyosarcoma
National Cancer Institute (NCI)
2006-10 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-06-12)

Check the Sunitinib (SU11248) Malate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sunitinib malate functions as a potent multi-targeted receptor tyrosine kinase inhibitor that binds to VEGFRs, PDGFRs, FLT3, and c-Kit, thereby suppressing receptor autophosphorylation and downstream pro-survival signaling pathways. This biochemical blockade inhibits endothelial cell proliferation and vascular endothelial growth factor-driven angiogenesis, leading to suppressed tumor vascularization and tumor growth inhibition in studied clinical indications such as renal cell carcinoma and gastrointestinal stromal tumors.

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.