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

Study Description

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Brief Summary:

The purpose of this study is to assess the response rate (per RECIST 1.1) in participants who receive mocetinostat and gemcitabine after documented progression of leiomyosarcoma on a gemcitabine containing regimen.

Condition or disease	Intervention/treatment	Phase
Metastatic Leiomyosarcoma	Drug: Mocetinostat; Drug: Gemcitabine	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	20 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	September 2015
Actual Primary Completion Date :	November 2016
Actual Study Completion Date :	November 2016

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Mocetinostat and gemcitabine	Drug: Mocetinostat Drug: Gemcitabine

Outcome Measures

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Primary Outcome Measures :

1. Response rate (per RECIST 1.1) in participants who receive mocetinostat and gemcitabine [ Time Frame: 27 months ]
   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.

Secondary Outcome Measures :

1. Duration of response in participants who receive mocetinostat and gemcitabine [ Time Frame: 27 months ]
   The duration of objective response will be measured from the time measurement criteria are first met until disease progression is objectively documented.
2. Progression free survival (PFS) in participants who receive mocetinostat and gemcitabine [ Time Frame: 27 months ]
   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.
3. Number and type of Adverse Events related to oral mocetinostat when given in combination with infusional gemcitabine at a rate of 10 mg/m2/min. [ Time Frame: 27 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Age ≥ 18 years
• Histologically documented leiomyosarcoma
• Prior systemic therapy with a gemcitabine containing regimen
• ECOG Performance Status of ≤ 1
• Measurable metastatic disease with a target lesion that has increased in size by 20% in maximal dimension either during or within six months after treatment with chemotherapy using a gemcitabine containing regimen
• Adequate organ function within 14 days of study entry
• Patients or their legal representative must be able to read (or have read to them), understand, and sign a written informed consent (approved by the institutional review board) within 14 days prior to start of treatment.

Exclusion Criteria:

• Concurrent, clinically significant, active malignancies (excluding basal cell carcinoma or cervical intraepithelial neoplasia [CIN] in situ or melanoma in situ) (Stage II portion only)
• Patients with baseline QTcF ≥ 480 msec
• Patients with uncontrolled concurrent illness, active infection requiring i.v. antibiotics, or uncontrolled infections, or a fever > 38.5°C on the day of scheduled dosing
• Patients with serious illnesses, medical conditions, or other medical history, including a prior history of pericarditis/pericardial effusion, or abnormal laboratory results, which, in the investigator's opinion, would be likely to interfere with a patient's participation in the study, or with the interpretation of the results
• Patients who have received any investigational drug within 28 days prior to Day 1 of study entry (an investigational drug is one for which there is no approved indication), or who are receiving concurrent treatment with other experimental drugs or anti-cancer therapy
• Pregnant or lactating women. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test documented within 72 hours prior to starting study drug or a urine pregnancy test shall be done on Day 1 of Cycle 1
• Women of child bearing potential and their partners must use an acceptable method of contraception while enrolled on this study, and for a period of 3 months following study drug treatment. Patients unwilling or unable to follow this guideline will be excluded. Investigators should follow their Institutional standard regarding acceptable methods of contraception.
• Known hypersensitivity to HDAC inhibitors or to any of the components of mocetinostat
• Known hypersensitivity to gemcitabine
• Any condition that will put the patient at undue risk or discomfort as a result of adherence to study procedures. For example, consider requirement to take mocetinostat with water and recommendation to avoid agents that increase gastric pH
• Any condition (e.g., known or suspected poor compliance, psychological instability, geographical location, etc) that, in the judgment of the investigator, may affect the patient's ability to sign the informed consent and undergo study procedures.

Contacts and Locations

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Locations

United States, Massachusetts
Massachusetts General Hospital/Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

Sarcoma Alliance for Research through Collaboration

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Sarcoma Alliance for Research through Collaboration
ClinicalTrials.gov Identifier:	NCT02303262 History of Changes
Other Study ID Numbers:	SARC018
First Posted:	November 27, 2014
Last Update Posted:	February 16, 2018
Last Verified:	August 2016

Additional relevant MeSH terms:

Leiomyosarcoma; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Gemcitabine; Mocetinostat; Antimetabolites, Antineoplastic; Antimetabolites	Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antiviral Agents; Anti-Infective Agents; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Histone Deacetylase Inhibitors