At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 20 enrolled

Drug / intervention

Mocetinostat +1 moredrug

Likely dose

Mocetinostat 70 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02303262

NCT02303262Phase 2Completed

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A Phase II Study of Mocetinostat Administered With Gemcitabine for Patients With Metastatic Leiomyosarcoma With Progression or Relapse Following Prior Treatment With Gemcitabine-Containing Therapy

Sarcoma Alliance for Research through Collaboration·interventional·Posted Nov 27, 2014·Updated Jan 29, 2019

In Brief

A Phase 2 clinical trial evaluating Mocetinostat and Gemcitabine for Metastatic Leiomyosarcoma. Completed, enrolled 20 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMetastatic Leiomyosarcoma

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

201520162017201820192020202120222023202420252026

First PostedNov 2014

Enrollment StartNov 2015

Primary CompletionDec 2016

TodayJul 2026

First PostedNov 27, 2014

Enrollment StartNov 12, 2015

Primary CompletionDec 1, 2016

TodayJul 2, 2026

Enrollment to primary: 1.1 yearsPosted 11.6 years ago

Interventions

Mocetinostatdrug

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.

Gemcitabinedrug

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.