Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Disease Progression

Leiomyosarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Sarcoma

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Mocetinostat

Antimetabolites

Histone Deacetylase Inhibitors

Enzyme Inhibitors

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

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.

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.

Edwin Choy, MD, PhD

Shreyas Patel, MD

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.

SARC018: A Study of Mocetinostat and Gemcitabine in Patients With Metastatic Leiomyosarcoma

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

Response rate (CR or PR) will be calculated by the number of patients achieving a response divided by the number of patients having been evaluated for response. Per Response Evaluation Criteria in Solid Tumors (RECIST): Complete Response (CR) is the disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of longest diameters of all target lesions.

The duration of objective response will be measured from the time measurement criteria are first met until disease progression is objectively documented.

Progression free survival is defined as the time from treatment initiation to the earlier date of assessment of objective progression or death by any cause in the absence of progression. Progression Free Survival (PFS) is defined as the time from treatment initiation to the earlier date of assessment of objective progression or death by any cause in the absence of progression. Progression will be assessed by RECIST v. 1.1.

Sarcoma Alliance for Research through Collaboration

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

Mocetinostat: 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.

Gemcitabine: 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.

Spots Global Cancer Trial Database for SARC018: A Study of Mocetinostat and Gemcitabine in Patients With Metastatic Leiomyosarcoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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