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Last Updated: November 2, 2024

CLINICAL TRIALS PROFILE FOR PEXIDARTINIB HYDROCHLORIDE


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All Clinical Trials for PEXIDARTINIB HYDROCHLORIDE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01349036 ↗ A Phase 2 Study of PLX3397 in Patients With Recurrent Glioblastoma Terminated Plexxikon Phase 2 2011-12-03 The objective of this study is to evaluate the response of subjects with recurrent glioblastoma to continuous therapy of PLX3397.
NCT01349036 ↗ A Phase 2 Study of PLX3397 in Patients With Recurrent Glioblastoma Terminated Daiichi Sankyo, Inc. Phase 2 2011-12-03 The objective of this study is to evaluate the response of subjects with recurrent glioblastoma to continuous therapy of PLX3397.
NCT01525602 ↗ Safety Study of PLX3397 and Paclitaxel in Patients With Advanced Solid Tumors Completed Plexxikon Phase 1 2012-05-01 This was a 3-part study designed to explore the safety and tolerability of escalating doses of PLX3397 with weekly paclitaxel to establish a recommended Phase 2 dose (RP2D), to confirm RP2D in participants with advanced non-resectable solid tumors, and to determine the efficacy of PLX3397 600 mg twice daily (BID) administered in combination with weekly paclitaxel in participants with advanced, metastatic or non-resectable, platinum-resistant or -refractory epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
NCT01525602 ↗ Safety Study of PLX3397 and Paclitaxel in Patients With Advanced Solid Tumors Completed Daiichi Sankyo, Inc. Phase 1 2012-05-01 This was a 3-part study designed to explore the safety and tolerability of escalating doses of PLX3397 with weekly paclitaxel to establish a recommended Phase 2 dose (RP2D), to confirm RP2D in participants with advanced non-resectable solid tumors, and to determine the efficacy of PLX3397 600 mg twice daily (BID) administered in combination with weekly paclitaxel in participants with advanced, metastatic or non-resectable, platinum-resistant or -refractory epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
NCT01790503 ↗ A Phase 1b/2 Study of PLX3397 + Radiation Therapy + Temozolomide in Patients With Newly Diagnosed Glioblastoma Completed Plexxikon Phase 1/Phase 2 2013-07-18 The study objectives are to assess the potential for PLX3397 to improve the efficacy of standard of care radiation therapy (RT) + temozolomide in patients with newly diagnosed glioblastoma (GBM).
NCT01790503 ↗ A Phase 1b/2 Study of PLX3397 + Radiation Therapy + Temozolomide in Patients With Newly Diagnosed Glioblastoma Completed Daiichi Sankyo, Inc. Phase 1/Phase 2 2013-07-18 The study objectives are to assess the potential for PLX3397 to improve the efficacy of standard of care radiation therapy (RT) + temozolomide in patients with newly diagnosed glioblastoma (GBM).
NCT02371369 ↗ Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS) Completed Daiichi Sankyo Inc. Phase 3 2015-05-11 This is a Phase 3 clinical study, which aims to evaluate the effectiveness of an investigational drug called pexidartinib for the treatment of certain tumors for which surgical removal could cause more harm than good. The main purpose of this study is to gather information about the investigational drug pexidartinib, which may help to treat tumors of pigmented villonodular synovitis (PVNS) or giant cell tumor of the tendon sheath (GCT-TS). The study consists of two parts with a follow-up period. In Part 1, eligible study participants will be assigned to receive either pexidartinib or matching placebo for 24 weeks. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. MRI scans will be used to evaluate the response of the tumors to the treatment. Some subjects, assigned to placebo in Part 1 transitioned to pexidartinib for Part 2. Then a protocol amendment was written to allow only pexidartinib patients to continue into Part 2. Part 2 is a long-term treatment phase in which all participants receive open-label pexidartinib. There was also a follow-up period added to Part 2.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for PEXIDARTINIB HYDROCHLORIDE

Condition Name

Condition Name for PEXIDARTINIB HYDROCHLORIDE
Intervention Trials
Tenosynovial Giant Cell Tumor 4
Melanoma 2
Gastrointestinal Stromal Tumor (GIST) 2
Giant Cell Tumors of the Tendon Sheath 1
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Condition MeSH

Condition MeSH for PEXIDARTINIB HYDROCHLORIDE
Intervention Trials
Giant Cell Tumors 4
Giant Cell Tumor of Tendon Sheath 4
Gastrointestinal Stromal Tumors 3
Neoplasms 3
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Clinical Trial Locations for PEXIDARTINIB HYDROCHLORIDE

Trials by Country

Trials by Country for PEXIDARTINIB HYDROCHLORIDE
Location Trials
United States 68
Korea, Republic of 6
Australia 5
Taiwan 4
Italy 3
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Trials by US State

Trials by US State for PEXIDARTINIB HYDROCHLORIDE
Location Trials
New York 8
Massachusetts 7
California 7
Texas 6
Michigan 5
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Clinical Trial Progress for PEXIDARTINIB HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for PEXIDARTINIB HYDROCHLORIDE
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for PEXIDARTINIB HYDROCHLORIDE
Clinical Trial Phase Trials
Completed 11
Terminated 2
Active, not recruiting 2
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Clinical Trial Sponsors for PEXIDARTINIB HYDROCHLORIDE

Sponsor Name

Sponsor Name for PEXIDARTINIB HYDROCHLORIDE
Sponsor Trials
Plexxikon 13
Daiichi Sankyo, Inc. 11
Daiichi Sankyo Co., Ltd. 4
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Sponsor Type

Sponsor Type for PEXIDARTINIB HYDROCHLORIDE
Sponsor Trials
Industry 35
Other 2
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