Tenosynovial giant cell tumor
Conditions
Interventions
pexidartinib 400 mg twice a day, oral administration
Sponsors
Inoguchi Akihiro
Eligibility
Sex/Gender
All
Inclusion 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 1.1 (except that a minimal size of 2 cm is required), assessed from MRI scan by a central radiologist.
Exclusion criteria
Exclusion criteria: - Known metastatic TGCT. - Pre-existing increased serum transaminases; total bilirubin or direct bilirubin (>ULN); or active liver or biliary tract disease, including increased ALP. - 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 subject`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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Dose-limiting toxicity, pharmacokinetics parameters Part 2: Objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1, Part 2: Treatment-emergent adverse events (TEAEs) and other safety parameters during the study Part 2: Tumor volume score, Range of motion, Patient-Reported Outcomes Measurement Information System (PROMIS) physical function scale,Brief Pain Inventory (BPI) | — |
Contacts
Public ContactContact for Clinical Trial Information
DAIICHI SANKYO Co.,Ltd.
Outcome results
None listed