Conditions: Metastatic Leiomyosarcoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 20
Healthy volunteers: no

Brief summary:
This is an open-label, multi-center, Phase II trial studying the combination of mocetinostat and gemcitabine in patients who have previously demonstrated disease progression either while, or within six months after, receiving chemotherapy with a gemcitabine-based regimen.

Detailed description:

Arms:
arm 1: For each 21-day cycle, gemcitabine is administered on days 5 and 12 and mocetinostat is administered 3 days a week.

Interventions: intervention 1: Mocetinostat intervention 2: Gemcitabine
Intervention descriptions: intervention 1: Mocetinostat is taken orally at 70 mg/dose, 3 days per week, during cycle 1. Dose is increased to 90 mg starting at cycle 2. intervention 2: Gemcitabine is administered via intravenous infusion at 1,000 mg/m2 at a rate of approximately 10 mg/m2/minute, on days 5 and 12 of every cycle.

Protocol document: