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Last Updated: May 11, 2021

DrugPatentWatch Database Preview

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
NCT01525602 Safety Study of PLX3397 and Paclitaxel in Patients With Advanced Solid Tumors Recruiting Plexxikon Phase 1 2012-05-01 The goal of this clinical study is to learn how PLX3397 and paclitaxel work together to affect the growth of cancer cells in advanced solid tumors.
NCT02734433 Study of Pexidartinib in Asian Subjects With Advanced Solid Tumors Recruiting Quintiles, Inc. Phase 1 2016-06-01 This is a Phase 1, non-randomized, open-label, multiple dose study of pexidartinib in Asian subjects with advanced solid tumors. The study will be conducted in a dose escalation to assess the safety and tolerability, PK and PD, and preliminary antitumor activity of pexidartinib.
NCT02734433 Study of Pexidartinib in Asian Subjects With Advanced Solid Tumors Recruiting Daiichi Sankyo Co., Ltd. Phase 1 2016-06-01 This is a Phase 1, non-randomized, open-label, multiple dose study of pexidartinib in Asian subjects with advanced solid tumors. The study will be conducted in a dose escalation to assess the safety and tolerability, PK and PD, and preliminary antitumor activity of pexidartinib.
NCT02777710 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 Recruiting AstraZeneca Phase 1 2016-06-01 Colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC) are the most common gastrointestinal cancers in Western countries and are both associated with significant morbidity and mortality. An intriguing similarity between CRC and PDAC is the fact that the newly developed immune checkpoint inhibitors, especially PD1/PDL1 inhibitors, seem to have limited efficacy as single agents in both of these tumor types. Recent preclinical studies point towards alternatively activated (M2-type) macrophages as possible culprits in inducing local immune protection from cytotoxic T cells and resistance to PD1/PD-L1 targeted agents. We hypothesize that CSF1R blockade will deplete the tumor microenvironment of M2 macrophages, thus favoring the induction of a cytotoxic anti-tumor T-cell response following PD-L1 blockade with an anti-PD-L1 monoclonal antibody. So we propose to conduct a Phase I dose escalation study in order to evaluate the safety and clinical activity of a combined treatment associating an anti-CSF1R (PEXIDARTINIB) with an anti-PD-L1 (DURVALUMAB) in patients with advanced/metastatic colorectal or pancreatic cancers. Dose escalation part will determine the Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of Pexidartinib given in combination with Durvalumab. Extension part will evaluate the clinical activity of the combination at the RP2D.
NCT02777710 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 Recruiting Plexxikon Phase 1 2016-06-01 Colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC) are the most common gastrointestinal cancers in Western countries and are both associated with significant morbidity and mortality. An intriguing similarity between CRC and PDAC is the fact that the newly developed immune checkpoint inhibitors, especially PD1/PDL1 inhibitors, seem to have limited efficacy as single agents in both of these tumor types. Recent preclinical studies point towards alternatively activated (M2-type) macrophages as possible culprits in inducing local immune protection from cytotoxic T cells and resistance to PD1/PD-L1 targeted agents. We hypothesize that CSF1R blockade will deplete the tumor microenvironment of M2 macrophages, thus favoring the induction of a cytotoxic anti-tumor T-cell response following PD-L1 blockade with an anti-PD-L1 monoclonal antibody. So we propose to conduct a Phase I dose escalation study in order to evaluate the safety and clinical activity of a combined treatment associating an anti-CSF1R (PEXIDARTINIB) with an anti-PD-L1 (DURVALUMAB) in patients with advanced/metastatic colorectal or pancreatic cancers. Dose escalation part will determine the Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of Pexidartinib given in combination with Durvalumab. Extension part will evaluate the clinical activity of the combination at the RP2D.
NCT02777710 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 Recruiting Centre Leon Berard Phase 1 2016-06-01 Colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC) are the most common gastrointestinal cancers in Western countries and are both associated with significant morbidity and mortality. An intriguing similarity between CRC and PDAC is the fact that the newly developed immune checkpoint inhibitors, especially PD1/PDL1 inhibitors, seem to have limited efficacy as single agents in both of these tumor types. Recent preclinical studies point towards alternatively activated (M2-type) macrophages as possible culprits in inducing local immune protection from cytotoxic T cells and resistance to PD1/PD-L1 targeted agents. We hypothesize that CSF1R blockade will deplete the tumor microenvironment of M2 macrophages, thus favoring the induction of a cytotoxic anti-tumor T-cell response following PD-L1 blockade with an anti-PD-L1 monoclonal antibody. So we propose to conduct a Phase I dose escalation study in order to evaluate the safety and clinical activity of a combined treatment associating an anti-CSF1R (PEXIDARTINIB) with an anti-PD-L1 (DURVALUMAB) in patients with advanced/metastatic colorectal or pancreatic cancers. Dose escalation part will determine the Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of Pexidartinib given in combination with Durvalumab. Extension part will evaluate the clinical activity of the combination at the RP2D.
>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 3
Healthy Volunteers 1
Solid Tumors 1
Gastrointestinal Stromal Tumor (GIST) 1
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Condition MeSH

Condition MeSH for Pexidartinib Hydrochloride
Intervention Trials
Giant Cell Tumors 3
Giant Cell Tumor of Tendon Sheath 3
Neoplasm Metastasis 1
Colorectal Neoplasms 1
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Clinical Trial Locations for Pexidartinib Hydrochloride

Trials by Country

Trials by Country for Pexidartinib Hydrochloride
Location Trials
United States 24
Taiwan 3
Korea, Republic of 3
Australia 2
China 2
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Trials by US State

Trials by US State for Pexidartinib Hydrochloride
Location Trials
California 3
New York 3
Florida 2
Massachusetts 2
Arizona 2
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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 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Pexidartinib Hydrochloride
Clinical Trial Phase Trials
Not yet recruiting 6
Recruiting 5
Completed 1
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Clinical Trial Sponsors for Pexidartinib Hydrochloride

Sponsor Name

Sponsor Name for Pexidartinib Hydrochloride
Sponsor Trials
Plexxikon 4
Daiichi Sankyo, Inc. 4
Daiichi Sankyo Co., Ltd. 3
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Sponsor Type

Sponsor Type for Pexidartinib Hydrochloride
Sponsor Trials
Industry 15
Other 2
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