Pimicotinib for Giant Cell Tumor

Recruiting in Palo Alto (17 mi)

+39 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Abbisko Therapeutics Co, Ltd

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests Pimicotinib, a new drug, in patients with Tenosynovial Giant Cell Tumor (TGCT). The drug aims to stop the tumor from growing by blocking signals that help tumor cells grow. The study will check if the drug works well and is safe for these patients.

Eligibility Criteria

Adults over 18 with a confirmed diagnosis of Tenosynovial Giant Cell Tumor (TGCT) that can't be surgically removed and have at least one measurable lesion. They must understand the study, sign consent, have stable pain medication needs, adequate organ and bone marrow function, and an ECOG performance status of 0 or 1.

Inclusion Criteria

Participants should complete stiffness and pain scales during the screening period, and symptomatic disease because of active TGCT should meet minimum requirements as outlined in study protocol

I am fully active or restricted in physically strenuous activity but can do light work.

I am 18 years old or older.

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Exclusion Criteria

Known allergy or hypersensitivity to any components of the investigational drug product

Any other clinically significant comorbidities, which in the judgment of the Investigator, could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the patient to safety risks

I have been treated with specific inhibitors but not those targeting CSF-1/CSF-1R, except imatinib and nilotinib are okay.

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Treatment Details

Interventions

Pimicotinib(ABSK021) (Tyrosine Kinase Inhibitor)
Placebo (Other)

Trial OverviewThe trial is testing Pimicotinib (ABSK021), comparing it to a placebo to see if it's effective and safe for TGCT patients. Part one lasts about 24 weeks with either Pimicotinib or placebo; part two continues with Pimicotinib for another 24 weeks.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 1/Part 2/Part 3- Pimicotinib(ABSK021)/ Pimicotinib(ABSK021)Experimental Treatment1 Intervention

Participants receive the blinded treatment of ABSK021 for 24 weeks in Part 1 and continue on the open-label Pimicotinib(ABSK021) in Part 2 and Part 3.

Group II: Part 1- Placebo/ Pimicotinib(ABSK021)Placebo Group2 Interventions

Participants receive the blinded treatment of matching placebo for 24 weeks in Part 1 and have option to receive the open-label Pimicotinib(ABSK021) in Part 2.