A Study of Pexidartinib in Tenosynovial Giant Cell Tumor in Japan

Launched by DAIICHI SANKYO CO., LTD. · Jan 8, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a medication called pexidartinib to see how safe and effective it is for adults with a condition known as tenosynovial giant cell tumor (TGCT). TGCT can cause severe pain and limit movement, and the study focuses on patients who cannot improve with surgery. The trial is taking place in Japan and is currently active, although it is not recruiting new participants at this time.

To be eligible for this study, participants need to be at least 20 years old and have a confirmed diagnosis of TGCT that causes significant symptoms. They must also have measurable disease that can be seen on an MRI scan. However, patients who have TGCT that has spread to other parts of the body or have certain liver or other serious health issues will not be able to participate. Throughout the study, participants will be monitored closely to assess how well they respond to the treatment and if there are any side effects. This trial is an important step in finding better options for managing TGCT when surgery is not a viable option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥20 years
• • A diagnosis of TGCT (i) that has been histologically confirmed by a pathologist1 and (ii) associated with severe morbidity or functional limitations and not amenable to improvement with surgery determined consensually by qualified personnel (eg, 2 surgeons or a multi-disciplinary tumor board).
• • Measurable disease as defined by RECIST version 1.1 (except that a minimal size of 2 cm is required), assessed from MRI scan by a central radiologist.
• Exclusion Criteria:
• • Known metastatic TGCT.
• • Pre-existing increased serum transaminases; total bilirubin or direct bilirubin (\>upper limit of normal); or active liver or biliary tract disease, including increased alkaline phosphatase.
• • Significant concomitant arthropathy in the affected joint, serious illness, uncontrolled infection, or a medical or psychiatric history that, in the Investigator's opinion, would likely interfere with a participant's study participation or the interpretation of his or her results.
• • Use of strong cytochrome P450 3A inducers, including St John's wort, proton pump inhibitors and potassium-competitive acid blockers, or other products known to cause hepatotoxicity.