Musculoskeletal Diseases

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Wounds and Injuries

Nervous System Diseases

Rare Diseases

Synovitis

Giant Cell Tumors

Giant Cell Tumor of Tendon Sheath

Synovitis, Pigmented Villonodular

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Joint Diseases

Tendinopathy

Muscular Diseases

Pigmented Villonodular Synovitis

Participants with TGCT who will receive oral pexidartinib 800 mg (400 mg twice daily \[BID\]).

400 mg twice daily for a total daily dose of 800 mg (each capsule contains 200 mg of pexidartinib for oral administration)

Pexidartinib

Daiichi Sankyo Contact for Clinical Trial Information

See Central Contact

Global Clinical Leader

This phase 2, multicenter, two-part, open-label, single-arm study will be conducted in Japan and will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of pexidartinib in adult participants with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitation and not amenable to improvement with surgery.

This study will consist of 2 parts. In Part 1, pexidartinib 800 mg/day (400 mg twice a day \[BID\]) will be administered on an empty stomach and tolerability and PK of pexidartinib will be evaluated to determine the initiation of Part 2. In Part 2, pexidartinib 800 mg/day (400 mg BID) will be administered on an empty stomach and efficacy, safety, and PK of pexidartinib will be evaluated.

A Study of Pexidartinib in Tenosynovial Giant Cell Tumor in Japan

A Phase 2, Multicenter, Two-Part, Open-Label Study of Pexidartinib in Adult Subjects With Tenosynovial Giant Cell Tumor in Japan

The number of participants with dose-limiting toxicities will be assessed.

Cmax is the maximum concentration of pexidartinib and ZAAD-1006a in plasma.

AUClast is the area under the concentration-time curve from time zero to time of last measurable concentration of pexidartinib and ZAAD-1006a in plasma.

AUCinf is the area under the concentration-time curve up to infinity of pexidartinib and ZAAD-1006a in plasma.

Tmax is the time to reach maximum concentration of pexidartinib and ZAAD-1006a in plasma.

ORR will be assessed by centrally reviewed MRI scan based on RECIST version 1.1.

ORR will be assessed by centrally reviewed MRI scan based on TVS.

Mean change from baseline in ROM of the affected joint, relative to a reference standard for the same joint will be assessed.

Mean change from baseline score in the PROMIS Physical Function Scale will be assessed.

Proportion of responders will be assessed based on the BPI Worst Pain NRS item and analgesic use by BPI-30 definition (ie, 30% or more improvement in average NRS).

BOR will be assessed by centrally reviewed magnetic resonance imaging (MRI) scan based on RECIST version 1.1.

BOR will be assessed by centrally reviewed MRI scan based on TVS.

DoR will be assessed by centrally reviewed MRI scan based on RECIST version 1.1.

DoR will be assessed by centrally reviewed MRI scan based on TVS.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Pexidartinib in Tenosynovial Giant Cell Tumor in Japan	NCT04703322	Tenosynovial Gi...	Pexidartinib	20 Years -	Daiichi Sankyo
A Study of Pexidartinib in Tenosynovial Giant Cell Tumor in Japan	NCT04703322	Tenosynovial Gi...	Pexidartinib	20 Years -	Daiichi Sankyo
A Study of Pexidartinib in Tenosynovial Giant Cell Tumor in Japan	NCT04703322	Tenosynovial Gi...	Pexidartinib	20 Years -	Daiichi Sankyo

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Every month we try and update this database with for gctts cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gctts cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.