SARC018: A Study of Mocetinostat and Gemcitabine in Patients With Metastatic Leiomyosarcoma
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| ClinicalTrials.gov Identifier: NCT02303262 |
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Recruitment Status :
Completed
First Posted : November 27, 2014
Last Update Posted : February 16, 2018
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Sponsor:
Sarcoma Alliance for Research through Collaboration
Information provided by (Responsible Party):
Sarcoma Alliance for Research through Collaboration
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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 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 |
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| Arm | Intervention/treatment |
|---|---|
| Experimental: Mocetinostat and gemcitabine |
Drug: Mocetinostat Drug: Gemcitabine |
Primary Outcome Measures :
- 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 :
- 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.
- 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.
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02303262
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
| 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 Key Record Dates |
| Last Update Posted: | February 16, 2018 |
| Last Verified: | August 2016 |
Additional relevant MeSH terms:
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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 |