A Phase 3 Double Blind Randomised Study of Orally Administered PLX3397
Research type
Research Study
Full title
A Double-blind, Randomized, Placebo-controlled Phase 3 Study of Orally Administered PLX3397 in Subjects with Pigmented Villonodular Synovitis or Giant Cell Tumor of the Tendon Sheath
IRAS ID
173624
Contact name
Robin Jones
Contact email
Sponsor organisation
Daiichi Sankyo, Inc
Eudract number
2014-000148-14
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 8 months, 16 days
Research summary
The purpose of this study is to determine how safe and effective PLX3397 is in treating patients with Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS). Approximately 126 patients are planned to be recruited across 45 study sites internationally in the US, Canada, EU and Australia.
There will be two parts to the study; Part 1 will be a period of up to 24 weeks and Part 2 will be at least 24 weeks. The duration of Part 2 will vary among subjects, as this portion of the trial will continue until all subjects either complete 24 weeks of treatment or withdraw from the study. Subjects who complete Part 2 without experiencing progression or intolerability will be eligible to enter a separate protocol to continue receiving PLX3397.
In Part 1, patients will receive either PLX3397 or placebo for 24 weeks. Subjects will receive 1000 mg PLX3397 or matching placebo daily for the first 2 weeks. Patients will then take either take 800mg of PLX3397 or placebo daily for the rest of Part 1. Each treatment cycle is 28 days and subjects will be treated for up to 6 Cycles. Patients will commence Part 2 if considered safe to do so by the patient’s clinician. In Part 2, patients will receive a maximum starting dose of 800mg PLX3397 daily.
Patients will attend a number of clinic visits in which procedures will be conducted in order to assess the safety and efficacy of PLX3397. Study procedures include demographics, medical history, vital signs, weight, physical examination, range of motion assessment, 12-lead ECG, echocardiogram, blood tests, urine sampling, MRI scan and requesting patients to complete a series of questionnaires about how they are feeling.REC name
London - Riverside Research Ethics Committee
REC reference
15/LO/0924
Date of REC Opinion
7 Jul 2015
REC opinion
Further Information Favourable Opinion