Panobinostat has been evaluated across numerous clinical trials spanning Phase 1 through Phase 4, sponsored by academic institutions, cooperative groups, and pharmaceutical companies like Novartis and Celgene. Ranging in status from completed landmark Phase 3 studies to terminated, withdrawn, or unknown protocols, these trials primarily target hematologic malignancies, including multiple myeloma, acute myeloid leukemia, myelodysplastic syndromes, and Hodgkin's lymphoma. Additionally, research addresses pediatric and adult solid tumors such as diffuse intrinsic pontine glioma, melanoma, and non-small cell lung cancer.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05725200 | RECRUITING | Metastatic Colorectal Cancer |
Oslo University Hospital |
2022-09-27 | PHASE2 |
| NCT02386800 | ACTIVE_NOT_RECRUITING | Primary Myelofibrosis; Polycythemia Vera; Graft Versus Host Disease; Acute Myeloid Leukemia; Thalassemia |
Novartis Pharmaceuticals |
2015-03-05 | PHASE4 |
| NCT01245179 | RECRUITING | Sickle Cell Disease |
Abdullah Kutlar |
2010-11 | PHASE1 |
| NCT03632317 | WITHDRAWN | Glioma; Diffuse Intrinsic Pontine Glioma |
University of Michigan Rogel Cancer Center |
2019-10 | PHASE2 |
| NCT06240520 | UNKNOWN | Hiv |
Erasmus Medical Center |
2024-04 | PHASE1; PHASE2 |
| NCT02506959 | COMPLETED | Plasma Cell Leukemia; Plasmacytoma; Recurrent Plasma Cell Myeloma; Refractory Plasma Cell Myeloma |
M.D. Anderson Cancer Center |
2015-09-14 | PHASE2 |
| NCT04897880 | TERMINATED | Rhabdoid Tumor; Atypical Teratoid/Rhabdoid Tumor; Malignant Rhabdoid Tumor; Recurrent Brain Tumor, Childhood |
Australian & New Zealand Children's Haematology/Oncology Group |
2019-01-09 | PHASE2 |
| NCT04341311 | TERMINATED | Diffuse Intrinsic Pontine Glioma; Pediatric Brainstem Glioma; Pediatric Brainstem Gliosarcoma, Recurrent; Pediatric Cancer; Pediatric Brain Tumor; Diffuse Glioma |
Dana-Farber Cancer Institute |
2020-08-10 | PHASE1 |
| NCT04315064 | COMPLETED | Medulloblastoma |
The University of Texas Health Science Center, Houston |
2020-04-21 | EARLY_PHASE1 |
| NCT04326764 | TERMINATED | Acute Myeloid Leukaemia (AML); Myelodysplastic Syndromes (MDS) |
Goethe University |
2018-07-24 | PHASE3 |
| NCT02471430 | COMPLETED | HIV Infection |
Massachusetts General Hospital |
2016-05 | PHASE1; PHASE2 |
| NCT04956302 | TERMINATED | Recurrent Plasma Cell Myeloma; Refractory Plasma Cell Myeloma |
Abdullah Khan |
2021-09-27 | PHASE1 |
| NCT04804709 | TERMINATED | Diffuse Intrinsic Pontine Glioma; Diffuse Pontine and Thalamic Gliomas; Diffuse Midline Glioma, H3 K27M-Mutant |
Columbia University |
2021-07-28 | PHASE1 |
| NCT02890069 | COMPLETED | Colorectal Cancer, Non-small Cell Lung Carcinoma (Adenocarcinoma), Triple Negative Breast Cancer, Renal Cell Carcinoma |
Novartis Pharmaceuticals |
2016-10-14 | PHASE1 |
| NCT02717455 | COMPLETED | Glioma |
Pediatric Brain Tumor Consortium |
2016-06-28 | PHASE1 |
| NCT02961816 | WITHDRAWN | Lymphoma |
M.D. Anderson Cancer Center |
2017-06 | PHASE2 |
| NCT03982134 | WITHDRAWN | Melanoma; Non Small Cell Lung Cancer |
Muhammad Furqan |
2019-09 | PHASE1 |
| NCT03566199 | COMPLETED | Diffuse Intrinsic Pontine Glioma |
Sabine Mueller, MD, PhD |
2018-05-22 | PHASE1; PHASE2 |
| NCT03256045 | TERMINATED | Recurrent Plasma Cell Myeloma; Refractory Plasma Cell Myeloma |
University of Washington |
2018-02-08 | PHASE2 |
| NCT02756663 | WITHDRAWN | Multiple Myeloma |
Novartis Pharmaceuticals |
2016-12 | PHASE2 |
| NCT03878524 | TERMINATED | Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Anatomic Stage IV Breast Cancer AJCC v8; Anemia; Ann Arbor Stage III Hodgkin Lymphoma; Ann Arbor Stage III Non-Hodgkin Lymphoma; Ann Arbor Stage IV Hodgkin Lymphoma; Ann Arbor Stage IV Non-Hodgkin Lymphoma; Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative; Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Castration-Resistant Prostate Carcinoma; Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Hematopoietic and Lymphoid System Neoplasm; Locally Advanced Pancreatic Adenocarcinoma; Metastatic Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Pancreatic Adenocarcinoma; Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Primary Myelofibrosis; Recurrent Acute Lymphoblastic Leukemia; Recurrent Acute Myeloid Leukemia; Recurrent Chronic Lymphocytic Leukemia; Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Recurrent Hematologic Malignancy; Recurrent Hodgkin Lymphoma; Recurrent Myelodysplastic Syndrome; Recurrent Myelodysplastic/Myeloproliferative Neoplasm; Recurrent Myeloproliferative Neoplasm; Recurrent Non-Hodgkin Lymphoma; Recurrent Plasma Cell Myeloma; Recurrent Small Lymphocytic Lymphoma; Refractory Acute Lymphoblastic Leukemia; Refractory Acute Myeloid Leukemia; Refractory Chronic Lymphocytic Leukemia; Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Refractory Chronic Myelomonocytic Leukemia; Refractory Hematologic Malignancy; Refractory Hodgkin Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Myelodysplastic Syndrome; Refractory Myelodysplastic/Myeloproliferative Neoplasm; Refractory Non-Hodgkin Lymphoma; Refractory Plasma Cell Myeloma; Refractory Primary Myelofibrosis; Refractory Small Lymphocytic Lymphoma; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8; Unresectable Pancreatic Adenocarcinoma |
OHSU Knight Cancer Institute |
2020-04-01 | PHASE1 |
| NCT01496118 | COMPLETED | Multiple Myeloma |
SCRI Development Innovations, LLC |
2011-12 | PHASE1; PHASE2 |
| NCT02802163 | WITHDRAWN | Multiple Myeloma |
H. Lee Moffitt Cancer Center and Research Institute |
2017-06 | PHASE1; PHASE2 |
| NCT04341311 | Terminated | Diffuse Intrinsic Pontine Glioma|Pediatric Brainstem Glioma|Pediatric Brainstem Gliosarcoma Recurrent|Pediatric Cancer|Pediatric Brain Tumor|Diffuse Glioma |
Dana-Farber Cancer Institute|Celgene|Secura Bio Inc. |
2020-08-10 | Phase 1 |
| NCT01433445 | COMPLETED | Idiopathic Myelofibrosis; Post Essential Thrombocythemia Myelofibrosis; Post Polycythemia-Vera Myelofibrosis |
Novartis Pharmaceuticals |
2011-11-01 | PHASE1 |
| NCT02722941 | COMPLETED | Multiple Myeloma |
H. Lee Moffitt Cancer Center and Research Institute |
2016-06-10 | PHASE2 |
| NCT01301807 | COMPLETED | Non-Secretory Plasma Cell Myeloma; Plasmacytosis; Recurrent Plasma Cell Myeloma; Refractory Plasma Cell Myeloma |
M.D. Anderson Cancer Center |
2011-07-28 | PHASE1 |
| NCT02654990 | COMPLETED | Multiple Myeloma |
pharmaand GmbH |
2016-04-27 | PHASE2 |
| NCT03632317 | Withdrawn | Glioma|Diffuse Intrinsic Pontine Glioma |
University of Michigan Rogel Cancer Center |
2019-10 | Phase 2 |
| NCT03982134 | Withdrawn | Melanoma|Non Small Cell Lung Cancer |
Muhammad Furqan|Novartis Pharmaceuticals|University of Iowa |
2019-09 | Phase 1 |
| NCT00946647 | COMPLETED | Myelodysplastic Syndromes; Chronic Myelomonocytic Leukemia; Acute Myeloid Leukemia |
Novartis Pharmaceuticals |
2009-12-02 | PHASE1; PHASE2 |
| NCT01965353 | COMPLETED | Multiple Myeloma in Relapse |
Dana-Farber Cancer Institute |
2013-10 | PHASE1 |
| NCT01440582 | COMPLETED | Myeloma |
M.D. Anderson Cancer Center |
2013-02-18 | PHASE1 |
| NCT02588339 | COMPLETED | Graft Versus Host Disease; GVHD |
H. Lee Moffitt Cancer Center and Research Institute |
2016-03-04 | PHASE2 |
| NCT01802879 | COMPLETED | Hematologic Neoplasms |
Novartis Pharmaceuticals |
2013-06-24 | PHASE2 |
| NCT04326764 | Terminated | Acute Myeloid Leukaemia (AML)|Myelodysplastic Syndromes (MDS) |
Goethe University|Stichting Hemato-Oncologie voor Volwassenen Nederland|Polish Adult Leukemia Group|Schweizerische Arbeitsgemeinschaft für klinische Krebsforschung |
2018-07-24 | Phase 3 |
| NCT01693601 | COMPLETED | Myelofibrosis |
John Mascarenhas |
2013-01 | PHASE1; PHASE2 |
| NCT02057640 | COMPLETED | Multiple Myeloma; Kahler Disease; Plasma-Cell Myeloma; Myelomatosis |
Jason Valent |
2014-05-22 | PHASE1; PHASE2 |
| NCT02676323 | TERMINATED | Acute Myeloid Leukemia; Myelodysplastic Syndrome |
St. Jude Children's Research Hospital |
2016-05-03 | PHASE1 |
| NCT03515915 | Unknown status | Patients With Recurrent or Refractory Multiple Myeloma |
University Hospital Montpellier|Poitiers University Hospital |
2018-04-23 | -- |
| NCT01451268 | UNKNOWN | Myelodysplastic Syndrome; Acute Myeloid Leukemia |
Johann Wolfgang Goethe University Hospital |
2011-01 | PHASE1; PHASE2 |
| NCT02518750 | TERMINATED | Acute Lymphoblastic Leukemia; Lymphoma, Non-Hodgkin's; Leukemia, T-Cell; Leukemia, B-Cell |
St. Jude Children's Research Hospital |
2016-11-23 | PHASE2 |
| NCT02290431 | COMPLETED | Relapse/Refractory Multiple Myeloma |
Novartis Pharmaceuticals |
2014-12-16 | PHASE2 |
| NCT00532675 | COMPLETED | Multiple Myeloma |
Novartis Pharmaceuticals |
2008-04-22 | PHASE1 |
| NCT02032810 | COMPLETED | Melanoma; Skin Cancer |
H. Lee Moffitt Cancer Center and Research Institute |
2014-01-07 | PHASE1 |
| NCT02720510 | TERMINATED | Multiple Myeloma |
Novartis Pharmaceuticals |
2016-06-14 | PHASE2 |
| NCT01169636 | COMPLETED | Hodgkin's Lymphoma |
M.D. Anderson Cancer Center |
2011-01-31 | PHASE1; PHASE2 |
| NCT01032148 | TERMINATED | Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma |
Roswell Park Cancer Institute |
2009-12 | PHASE1 |
| NCT01336842 | COMPLETED | Solid Tumors; Non-Small Cell Lung Cancer (NSCLC) |
University of California, Davis |
2011-04 | PHASE1 |
| NCT01651039 | COMPLETED | Multiple Myeloma |
Ajai Chari |
2012-07 | PHASE2 |
| NCT01460940 | COMPLETED | Adult Lymphocyte Depletion Hodgkin Lymphoma; Adult Lymphocyte Predominant Hodgkin Lymphoma; Adult Mixed Cellularity Hodgkin Lymphoma; Adult Nodular Lymphocyte Predominant Hodgkin Lymphoma; Adult Nodular Sclerosis Hodgkin Lymphoma; Recurrent Adult Hodgkin Lymphoma |
Ohio State University Comprehensive Cancer Center |
2011-10-13 | PHASE2 |
| NCT01341834 | UNKNOWN | Nasopharyngeal Carcinoma, Lymphomas, Any EBV+ Solid Tumour |
National Cancer Centre, Singapore |
2010-03 | PHASE1 |
| NCT01261247 | COMPLETED | Adult Nasal Type Extranodal NK/T-cell Lymphoma; Anaplastic Large Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Hepatosplenic T-cell Lymphoma; Nodal Marginal Zone B-cell Lymphoma; Peripheral T-cell Lymphoma; Post-transplant Lymphoproliferative Disorder; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Adult T-cell Leukemia/Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Recurrent Small Lymphocytic Lymphoma; Small Intestine Lymphoma; Splenic Marginal Zone Lymphoma; Waldenstrom Macroglobulinemia |
Mayo Clinic |
2011-01-17 | PHASE2 |
| NCT00840346 | COMPLETED | Acute Myeloblastic Leukaemia |
PETHEMA Foundation |
2009-09 | PHASE1; PHASE2 |
| NCT01549431 | COMPLETED | Multiple Myeloma |
Emory University |
2012-01 | PHASE1 |
| NCT01238692 | COMPLETED | Diffuse Large B Cell Lymphoma |
Sarit Assouline |
2010-11 | PHASE2 |
| NCT00918333 | COMPLETED | Adult Nasal Type Extranodal NK/T-cell Lymphoma; Anaplastic Large Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; B-cell Adult Acute Lymphoblastic Leukemia; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Hepatosplenic T-cell Lymphoma; Nodal Marginal Zone B-cell Lymphoma; Post-transplant Lymphoproliferative Disorder; Primary Central Nervous System Non-Hodgkin Lymphoma; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Hodgkin 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 Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia; Refractory Multiple Myeloma; Splenic Marginal Zone Lymphoma; T-cell Adult Acute Lymphoblastic Leukemia; Waldenström Macroglobulinemia |
Mayo Clinic |
2009-06 | PHASE1; PHASE2 |
| NCT01463046 | COMPLETED | Acute Myeloid Leukemia; Advanced Myelodysplastic Syndrome |
University of California, San Francisco |
2012-01 | PHASE1 |
| NCT01582009 | TERMINATED | Clear Cell Renal Cell Carcinoma; Recurrent Renal Cell Cancer; Stage III Renal Cell Cancer; Stage IV Renal Cell Cancer |
Roswell Park Cancer Institute |
2010-03 | PHASE1; PHASE2 |
| NCT01321346 | COMPLETED | Lymphoblastic Leukemia, Acute, Childhood; Myelogenous Leukemia, Acute, Childhood; Hodgkin's Disease; Non-Hodgkin's Lymphoma |
Therapeutic Advances in Childhood Leukemia Consortium |
2011-03 | PHASE1 |
| NCT01111526 | COMPLETED | Graft-Versus-Host Disease |
H. Lee Moffitt Cancer Center and Research Institute |
2010-04 | PHASE1; PHASE2 |
| NCT01023308 | COMPLETED | Multiple Myeloma |
Novartis Pharmaceuticals |
2009-12-21 | PHASE3 |
| NCT01298934 | UNKNOWN | Primary Myelofibrosis; Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase; Post-Essential Thrombocythemia Related Myelofibrosis |
Ronald Hoffman |
2009-09 | PHASE1; PHASE2 |
| NCT00907179 | TERMINATED | Non-Small Cell Lung Cancer |
University of Pittsburgh |
2009-07 | PHASE1 |
| NCT02145715 | UNKNOWN | Multiple Myeloma |
Prof Jamie Cavenagh |
2013-01 | PHASE1; PHASE2 |
| NCT00978432 | TERMINATED | Diffuse Large B-cell Lymphoma |
Anne Beaven, MD |
2012-02 | PHASE2 |
| NCT00985946 | TERMINATED | Neuroendocrine Tumors |
University of Wisconsin, Madison |
2010-05 | PHASE2 |
| NCT00777049 | COMPLETED | Breast Cancer |
Translational Research in Oncology |
2009-02 | PHASE2 |
| NCT01658241 | COMPLETED | Nodal Lymphoma; Lymphoma With Cutaneous Involvement; Lymphoma in Leukemic Phase; Marrow Involvement With Lymphoma; Multiple Myeloma |
Peter MacCallum Cancer Centre, Australia |
2012-07-16 | PHASE2 |
| NCT00878436 | COMPLETED | Prostate Cancer; Prostatic Neoplasms |
NYU Langone Health |
2009-06 | PHASE1; PHASE2 |
| NCT01238965 | TERMINATED | Recurrent Colon Cancer; Recurrent Rectal Cancer; Stage IV Colon Cancer; Stage IV Rectal Cancer |
University of Southern California |
2010-10 | PHASE1 |
| NCT00925132 | TERMINATED | Metastatic Melanoma |
University of Iowa |
2009-12 | PHASE1; PHASE2 |
| NCT01504776 | COMPLETED | Mantle Cell Lymphoma |
Anand Jillella |
2011-04 | PHASE1 |
| NCT00997399 | COMPLETED | Advanced Solid Tumors |
Novartis Pharmaceuticals |
2010-03 | PHASE1 |
| NCT01242774 | COMPLETED | Acute Myeloid Leukemia (AML) |
Novartis Pharmaceuticals |
2010-10 | PHASE1 |
| NCT01613976 | COMPLETED | Myelodysplastic Syndromes (MDS); Chronic Myelomonocytic Leukemia (CMML); Acute Myeloid Leukemia (AML) |
Novartis Pharmaceuticals |
2012-08 | PHASE1 |
| NCT01884428 | UNKNOWN | Hodgkin's Lymphoma |
Armando Santoro, MD |
2011-07 | PHASE1 |
| NCT01005797 | COMPLETED | Renal Cancer; Non Small Cell Lung Cancer (NSCLC); Soft Tissue Sarcoma |
Medical University of South Carolina |
2009-11 | PHASE1 |
| NCT00967044 | COMPLETED | Lymphoma |
M.D. Anderson Cancer Center |
2009-11 | PHASE1; PHASE2 |
| NCT01083602 | COMPLETED | Relapsed and Bortezomib Refractory Multiple Myeloma; Refractory Multiple Myeloma; Multiple Myeloma in Relapse |
Novartis Pharmaceuticals |
2010-06 | PHASE2 |
| NCT01194908 | TERMINATED | Breast Cancer; Breast Tumors; Breast Neoplasms |
Emory University |
2010-07 | PHASE1; PHASE2 |
| NCT00901147 | COMPLETED | Peripheral T-cell Lymphoma (Not Otherwise Specified); Angioimmunoblastic T-cell Lymphoma; Extranodal NK/T-cell Lymphoma Nasal Type; Enteropathy- Type T-cell Lymphoma; Hepatosplenic T-cell Lymphoma; Anaplastic Large Cell Lymphoma (ALCL) (ALK-1 Negative); Relapsed ALCL (ALK-1 Positive) Post Autologous Transplant |
Singapore General Hospital |
2009-11 | PHASE2 |
| NCT01523834 | COMPLETED | Diffuse Large B-cell Lymphoma |
Fondazione Italiana Linfomi - ETS |
2011-02 | PHASE2 |
| NCT01175109 | UNKNOWN | Chordoma |
Deric M Park MD |
2011-10 | PHASE1 |
| NCT00532389 | COMPLETED | Multiple Myeloma |
Novartis Pharmaceuticals |
2007-10 | PHASE1 |
| NCT01324635 | TERMINATED | Recurrent Glioma; High-grade Meningioma; Brain Metastasis |
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University |
2012-05 | PHASE1 |
| NCT00859222 | COMPLETED | Malignant Glioma |
Patrick Y. Wen, MD |
2009-03 | PHASE1; PHASE2 |
| NCT01680094 | COMPLETED | HIV Infection |
University of Aarhus |
2012-09 | PHASE1; PHASE2 |
| NCT00742027 | COMPLETED | Classical Hodgkin's Lymphoma |
Novartis Pharmaceuticals |
2008-09-16 | PHASE2 |
| NCT01013597 | COMPLETED | Thyroid Carcinoma |
University of Wisconsin, Madison |
2010-01 | PHASE2 |
| NCT01105312 | COMPLETED | Breast Cancer |
Alliance for Clinical Trials in Oncology |
2010-09 | PHASE1; PHASE2 |
| NCT00738751 | COMPLETED | Lung Cancer; Head and Neck Cancer |
H. Lee Moffitt Cancer Center and Research Institute |
2008-11 | PHASE1 |
| NCT01282476 | TERMINATED | Diffuse Large B Cell Lymphoma |
Massachusetts General Hospital |
2011-06 | PHASE2 |
| NCT00891033 | TERMINATED | Multiple Myeloma |
University of Arkansas |
2009-04 | PHASE1 |
| NCT00691938 | COMPLETED | Leukemia, Myeloid, Acute; Myelodysplastic Syndromes |
Washington University School of Medicine |
2008-06 | PHASE1; PHASE2 |
| NCT00939159 | TERMINATED | Myelodysplastic Syndrome |
M.D. Anderson Cancer Center |
2009-08 | PHASE2 |
| NCT00425555 | COMPLETED | Cutaneous T-Cell Lymphoma |
Novartis Pharmaceuticals |
2007-01 | PHASE2 |
| NCT00878904 | COMPLETED | Unspecified Adult Solid Tumor, Protocol Specific |
University of California, San Francisco |
2009-09-13 | PHASE1 |
| NCT00686218 | COMPLETED | Leukemia |
City of Hope Medical Center |
2008-05 | PHASE1 |
| NCT01065467 | COMPLETED | Melanoma; Malignant Melanoma |
Dana-Farber Cancer Institute |
2010-02 | PHASE1 |
| NCT01528501 | TERMINATED | Metastatic Gastric Cancer |
Technical University of Munich |
2009-06 | PHASE2 |
| NCT00962507 | COMPLETED | Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm |
City of Hope Medical Center |
2009-07 | PHASE1 |
| NCT00743288 | COMPLETED | Multiple Myeloma |
Oncotherapeutics |
2008-07 | PHASE1; PHASE2 |
| NCT01007968 | COMPLETED | Advanced Solid Tumors |
Novartis Pharmaceuticals |
2010-03 | PHASE1 |
| NCT01034657 | TERMINATED | Myelodysplastic Syndrome (MDS) |
Novartis Pharmaceuticals |
2009-11 | PHASE2 |
| NCT01034163 | COMPLETED | Hodgkin's Lymphoma |
Novartis Pharmaceuticals |
2010-06 | PHASE3 |
| NCT01055483 | COMPLETED | Acute Myeloid Leukemia |
Novartis Pharmaceuticals |
2009-09 | PHASE1 |
| NCT00880269 | COMPLETED | Refractory Leukemia; Acute Myelogenous Leukemia |
Novartis Pharmaceuticals |
2009-08 | PHASE2 |
| NCT01136499 | COMPLETED | Soft Tissue Sarcoma |
Centre Leon Berard |
2010-01 | PHASE2 |
| NCT00690677 | COMPLETED | Colorectal Cancer |
Swedish Medical Center |
2008-06 | PHASE2 |
| NCT01159418 | UNKNOWN | Advanced Solid Tumors |
Southern Europe New Drug Organization |
2008-06 | PHASE1 |
| NCT00663832 | COMPLETED | Prostate Cancer |
Novartis Pharmaceuticals |
2008-02 | PHASE1 |
| NCT00936611 | COMPLETED | Waldenstrom's Macroglobulinemia |
Dana-Farber Cancer Institute |
2009-07 | PHASE2 |
| NCT00931762 | TERMINATED | Primary Myelofibrosis; Post-Polycythemia Vera; Post-Essential Thrombocytopenia |
Novartis Pharmaceuticals |
2009-08-31 | PHASE2 |
| NCT01055795 | COMPLETED | Advanced Solid Tumors |
Herbert Hurwitz |
2010-03 | PHASE1 |
| NCT00958022 | TERMINATED | Small Cell Lung Cancer |
Ahmad Tarhini |
2009-09 | PHASE1 |
| NCT00567879 | TERMINATED | Breast Cancer |
Novartis Pharmaceuticals |
2008-04 | PHASE1; PHASE2 |
| NCT01115036 | WITHDRAWN | Recurrent Glioblastoma |
Duke University |
2010-04 | PHASE2 |
| NCT01090973 | TERMINATED | Non-Hodgkin's Lymphoma |
H. Lee Moffitt Cancer Center and Research Institute |
2010-03 | PHASE2 |
| NCT00594230 | TERMINATED | Myelodysplastic Syndromes (MDS) |
SCRI Development Innovations, LLC |
2008-01 | PHASE2 |
| NCT00570284 | COMPLETED | Cancer |
Novartis Pharmaceuticals |
2007-11 | PHASE1 |
| NCT01056601 | TERMINATED | Pancreatic Cancer |
Masonic Cancer Center, University of Minnesota |
2010-09 | PHASE2 |
| NCT00823290 | TERMINATED | Hepatocellular Carcinoma |
University of Erlangen-Nürnberg Medical School |
2009-01 | PHASE1 |
| NCT00667862 | COMPLETED | Prostate Cancer |
Novartis Pharmaceuticals |
2008-03-18 | PHASE2 |
| NCT01160731 | WITHDRAWN | Lung Cancer |
Cancer Trials Ireland |
2009-11 | PHASE1 |
| NCT00723203 | TERMINATED | Leukemia |
City of Hope Medical Center |
2008-04 | PHASE2 |
| NCT00993642 | WITHDRAWN | Breast Cancer |
Tulane University Health Sciences Center |
2009-09 | EARLY_PHASE1 |
| NCT00788931 | COMPLETED | HER-2 Positive Breast Cancer; Metastatic Breast Cancer |
Novartis Pharmaceuticals |
2008-12 | PHASE1 |
| NCT00556088 | COMPLETED | Solid Tumors |
SCRI Development Innovations, LLC |
2007-12 | PHASE1 |
| NCT00873002 | TERMINATED | Liver Cancer |
Case Comprehensive Cancer Center |
2009-03 | PHASE1 |
| NCT00503451 | COMPLETED | Non-Hodgkin Lymphoma; Neoplasms |
Novartis Pharmaceuticals |
2007-09 | PHASE1 |
| NCT00550277 | COMPLETED | Renal Cell Carcinoma |
SCRI Development Innovations, LLC |
2008-01 | PHASE2 |
| NCT00777335 | TERMINATED | Breast Cancer |
Translational Research in Oncology |
2009-02 | PHASE2 |
| NCT00550199 | TERMINATED | Solid Tumors |
SCRI Development Innovations, LLC |
2007-11 | PHASE1 |
| NCT00670553 | COMPLETED | Prostate Cancer; Head & Neck Cancer; Esophageal Cancer |
Novartis Pharmaceuticals |
2008-09 | PHASE1 |
| NCT00621244 | COMPLETED | Lymphoma; Leukemia; Multiple Myeloma |
Novartis Pharmaceuticals |
2003-03-01 | PHASE1; PHASE2 |
| NCT00739414 | COMPLETED | Cancer; Advanced Solid Tumor |
Novartis Pharmaceuticals |
2008-07 | PHASE1 |
| NCT00490776 | TERMINATED | Cutaneous T-Cell Lymphoma |
Novartis Pharmaceuticals |
2007-07-05 | PHASE2 |
| NCT01222936 | COMPLETED | Small Cell Lung Carcinoma |
Southern Europe New Drug Organization |
2008-05 | PHASE2 |
| NCT00848523 | TERMINATED | Recurrent Malignant Gliomas |
Neurological Surgery, P.C. |
2008-11 | PHASE2 |
| NCT00632489 | COMPLETED | Breast Cancer |
SCRI Development Innovations, LLC |
2008-05 | PHASE1 |
| NCT00535951 | COMPLETED | Carcinoma, Non-Small-Cell Lung; Mesothelioma |
Novartis Pharmaceuticals |
2007-11 | PHASE1 |
| NCT00699296 | TERMINATED | Cutaneous T-Cell Lymphoma; Leukemia-Lymphoma, Adult T-Cell |
Novartis Pharmaceuticals |
2008-05 | PHASE2 |
| NCT00493766 | TERMINATED | Hormone Refractory Prostate Cancer |
Novartis Pharmaceuticals |
2006-05 | PHASE1 |
| NCT00472368 | COMPLETED | Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological Malignancies |
Novartis Pharmaceuticals |
2007-05 | PHASE1 |
| NCT00445068 | TERMINATED | Multiple Myeloma |
Novartis Pharmaceuticals |
2007-04-16 | PHASE2 |
| NCT00412997 | COMPLETED | Tumors; Cutaneous T-Cell Lymphoma |
Novartis |
2006-11 | PHASE1 |
| NCT00451035 | TERMINATED | Chronic Myeloid Leukemia in Chronic Phase |
Novartis Pharmaceuticals |
2007-02-19 | PHASE2 |
| NCT00449761 | TERMINATED | Leukemia, Myeloid, Chronic |
Novartis Pharmaceuticals |
2007-02-23 | PHASE2 |
| NCT00419536 | TERMINATED | Hormone Refractory Prostate Cancer Disease |
Novartis Pharmaceuticals |
2006-05 | PHASE1 |
| NCT01028313 | WITHDRAWN | Chronic Graft-Versus-Host Disease |
SCRI Development Innovations, LLC |
PHASE2 |
(data from https://clinicaltrials.gov, updated on 2023-02-21)
Mechanism and Biochemical Profile
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>).
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