PLX3397: Clinical Trials

22 trials of PLX3397, newest first

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14 completed, 5 terminated, 1 active not recruiting, 1 recruiting. 12 Phase 1, 12 Phase 2, 2 Phase 3, 1 Not applicable, 1 Phase 4.

By phase and status

PhaseTrialsStatus
Phase 112Completed 8, Terminated 3, Withdrawn 1
Phase 212Completed 7, Terminated 4, Recruiting 1
Phase 32Active not recruiting 1, Completed 1
Not applicable1Completed 1
Phase 41Completed 1

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Trials newest first · largest first

Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.

TrialPhaseStatusSponsorEnrollmentStartUpdated
A Study of Pexidartinib in Tenosynovial Giant Cell Tumor in Japan
Pexidartinib - Tenosynovial Giant Cell Tumor
Phase 2CompletedDaiichi Sankyo Co., Ltd.92021-03-152026-06-24
Study to Evaluate Discontinuation and Re-Treatment in Participants With Tenosynovial Giant Cell Tumor (TGCT) Previously Treated With Pexidartinib
Pexidartinib - Tenosynovial Giant Cell Tumor
Phase 4CompletedDaiichi Sankyo322020-10-202024-12-30
A Study of the Efficacy and Safety of Pexidartinib in Adult Subjects With TGCT
Pexidartinib - Tenosynovial Giant Cell Tumor
Phase 3Active not recruitingDaiichi Sankyo Co., Ltd.402020-09-252026-06-26
A Study of PLX3397 in Patients With Unresectable or Metastatic KIT-mutated Melanoma
PLX3397 - Melanoma
Not applicableCompletedDaiichi Sankyo Co., Ltd.62017-01-312026-01-13
Evaluation of Safety and Activity of an Anti-PDL1 Antibody (DURVALUMAB) Combined With CSF-1R TKI (PEXIDARTINIB) in Patients With Metastatic/Advanced Pancreatic or Colorectal Cancers
Pexidartinib, Durvalumab - Colorectal Cancer, Pancreatic Cancer
Phase 1CompletedCentre Leon Berard482016-06-012021-09-05
PLX3397 Plus Sirolimus in Unresectable Sarcoma and Malignant Peripheral Nerve Sheath Tumors
PLX3397, sirolimus - Sarcoma, Malignant Peripheral Nerve Sheath Tumors
Phase 1 / Phase 2TerminatedGulam Manji392015-11-042025-03-21
PLX3397 KIT in Acral aNd mucOsal Melanoma
PLX3397 - Malignant Melanoma
Phase 2CompletedThe Christie NHS Foundation Trust72015-10-012021-08-12
A Combination Clinical Study of PLX3397 and Pembrolizumab To Treat Advanced Melanoma and Other Solid Tumors
PLX3397, Pembrolizumab - Melanoma, Non-small Cell Lung Cancer
Phase 1 / Phase 2TerminatedDaiichi Sankyo782015-07-022020-03-05
PLX3397, Radiation Therapy, and Antihormone Therapy in Treating Patients With Intermediate- or High-Risk Prostate Cancer
Antiandrogen Therapy, Laboratory Biomarker Analysis, Multitargeted Tyrosine Kinase Inhibitor PLX3397 - Stage I Prostate Adenocarcinoma, Stage II Prostate Adenocarcinoma
Phase 1CompletedBarbara Ann Karmanos Cancer Institute82015-06-012020-10-06
Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS)
Pexidartinib, Placebo - Pigmented Villonodular Synovitis, Giant Cell Tumors of the Tendon Sheath
Phase 3CompletedDaiichi Sankyo1202015-05-112022-05-11
CGT9486 (Formerly Known as PLX9486) as a Single Agent and in Combination With PLX3397 (Pexidartinib) or Sunitinib in Participants With Advanced Solid Tumors
CGT9486, Pexidartinib, Sunitinib - Gastrointestinal Stromal Tumors
Phase 1 / Phase 2CompletedCogent Biosciences, Inc.512015-03-062025-02-14
A Phase 1b Open Label, Dose Escalation Study of PLX3397 in Combination With Vemurafenib in V600-mutated BRAF Melanoma
PLX3397, vemurafenib - V600-mutated BRAF Unresectable Melanoma, V600-mutated BRAF Metastatic Melanoma
Phase 1TerminatedDaiichi Sankyo132013-11-052020-05-28
A Phase 1b/2 Study of PLX3397 + Radiation Therapy + Temozolomide in Patients With Newly Diagnosed Glioblastoma
PLX3397, Radiation Therapy, Temozolomide - Patients With Newly Diagnosed Glioblastoma
Phase 1 / Phase 2CompletedDaiichi Sankyo652013-07-182020-06-30
Phase Ib/II Study of PLX 3397 and Eribulin in Patients With Metastatic Breast Cancer
PLX3397, Eribulin - Metastatic Breast Cancer
Phase 1 / Phase 2CompletedHope Rugo, MD672012-07-122020-07-17
Pilot Study of PLX3397 in Patients With Advanced Castration-Resistant Prostate Cancer (CRPC)
PLX3397 - Prostate Cancer
Phase 2TerminatedDaiichi Sankyo62012-05-252020-03-04
Safety Study of PLX3397 and Paclitaxel in Patients With Advanced Solid Tumors
PLX3397, Paclitaxel - Solid Tumors
Phase 1CompletedDaiichi Sankyo742012-05-012020-07-16
A Phase 2 Study of PLX3397 in Patients With Recurrent Glioblastoma
PLX3397 - Recurrent Glioblastoma
Phase 2TerminatedDaiichi Sankyo382011-12-032020-03-03
Phase 1/2 Safety and Efficacy of PLX3397 in Adults With Relapsed or Refractory Acute Myeloid Leukemia (AML)
PLX3397 - Acute Myeloid Leukemia
Phase 1 / Phase 2CompletedDaiichi Sankyo902011-11-212020-03-02
Safety and Efficacy Study of PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma
PLX3397 - Hodgkin Lymphoma
Phase 2CompletedDaiichi Sankyo202011-03-032020-06-30
Safety, Pharmacokinetic (PK), Pharmcodynamic (PD), and Drug-Drug Interaction of PLX3397 in Patients With Rheumatoid Arthritis Who Are Receiving Methotrexate
PLX3397 - Rheumatoid Arthritis
Phase 1WithdrawnPlexxikon2010-05-012015-03-17

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Conditions studied

Giant Cell Tumor of Tendon Sheath (4)  ·  Melanoma (3)  ·  Breast Neoplasms (2)  ·  Gastrointestinal Stromal Tumors (2)  ·  Glioblastoma (2)  ·  Neoplasm Metastasis (2)  ·  Neoplasms (2)  ·  Synovitis, Pigmented Villonodular (2)  ·  Arthritis, Rheumatoid (1)  ·  Brain Neoplasms (1)  ·  Carcinoma, Non-Small-Cell Lung (1)  ·  Colorectal Neoplasms (1)  ·  Hemangiosarcoma (1)  ·  Hodgkin Disease (1)  ·  Leukemia, Myeloid, Acute (1)

Sponsors

Daiichi Sankyo (11)  ·  Daiichi Sankyo Co., Ltd. (3)  ·  Barbara Ann Karmanos Cancer Institute (1)  ·  Centre Leon Berard (1)  ·  Cogent Biosciences, Inc. (1)  ·  Gulam Manji (1)  ·  Hope Rugo, MD (1)  ·  Plexxikon (1)  ·  QuantumLeap Healthcare Collaborative (1)  ·  The Christie NHS Foundation Trust (1)

Countries

United States (17)  ·  France (3)  ·  Australia (2)  ·  China (2)  ·  Germany (2)  ·  Hungary (2)  ·  Italy (2)  ·  Netherlands (2)  ·  Spain (2)  ·  Taiwan (2)  ·  United Kingdom (2)  ·  Canada (1)  ·  Denmark (1)  ·  Japan (1)  ·  Poland (1)

Top investigators

Alexander Perl, MD (1)  ·  Catherine Smith, MD (1)  ·  Elisabeth I. Heath, M.D. (1)  ·  Eunice Wang, MD (1)  ·  Gail Roboz, MD (1)  ·  Gulam A. Manji, MD (1)  ·  Hope S. Rugo, MD (1)  ·  Jessica Sachs, MD (1)  ·  John Pagel, MD, PhD (1)  ·  Laura Esserman, MD, MBA (1)  ·  Mark Levis, MD, PhD (1)

Results publications

PMID 33289960, PMID 21796368, PMID 22198468, PMID 22623692, PMID 22649152, PMID 24101040, PMID 24552317, PMID 26222558, PMID 27041409, PMID 27406346, PMID 27406347, PMID 28851423, PMID 31229240, PMID 32031889, PMID 32053137, PMID 32330242, PMID 32450725, PMID 32701140, PMID 32755241, PMID 34236401, PMID 34321280, PMID 34529000, PMID 34716196, PMID 34741021, PMID 35623341, PMID 35993306, PMID 36001000, PMID 36069821, PMID 36456573, PMID 37029329, PMID 37325931, PMID 37505107, PMID 38086377, PMID 38180338, PMID 38266104, PMID 38745646, PMID 39158353, PMID 39277671, PMID 39277672, PMID 39613746, PMID 39625569, PMID 40526879, PMID 40551254, PMID 40639409, PMID 40679371, PMID 40777112, PMID 40841499, PMID 41879562, PMID 42132251, PMID 42530945

NIH funding

2014 (1), 2015 (1), P30CA022453 (1)