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

NCT02303262 | Completed Phase 2 Results DMC

• 1 other identifier: SARC018
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 5

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.

Conditions

Metastatic Leiomyosarcoma

Outcome Measures

Primary Outcomes (1)

• Response Rate (Per RECIST 1.1)

  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.

  27 months

Secondary Outcomes (2)

• Duration of Response

  27 months

• Progression Free Survival (PFS)

  27 months

Study Arms (1)

Mocetinostat and gemcitabine

EXPERIMENTAL

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

Drug: Mocetinostat; Drug: Gemcitabine

Interventions

Mocetinostat DRUG

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.

Mocetinostat and gemcitabine

Gemcitabine DRUG

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.

Mocetinostat and gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sarcoma Alliance for Research through Collaboration: lead

Study Sites (5)

Massachusetts General Hospital/Dana Farber Cancer Institute

Boston, Massachusetts, 02114, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Leiomyosarcoma

Interventions

mocetinostat; Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: SARC
• Organization: SARC

sarc@sarctrials.org

(734) 930-7600

Study Officials

• Edwin Choy, MD, PhD

  MGH, Dana Farber/Harvard Cancer Center

  PRINCIPAL INVESTIGATOR

• Shreyas Patel, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: November 27, 2014
• Study Start: November 12, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 29, 2019
• Results First Posted: January 29, 2019

Record last verified: 2018-11

Locations

US (5)