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 | >Sponsor | >Phase | >Start Date | >Summary |
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