SARC018: A Study of Mocetinostat and Gemcitabine in Patients With Metastatic Leiomyosarcoma
Condition: Metastatic Leiomyosarcoma
MeSH terms: Leiomyosarcoma
Intervention: Mocetinostat; Gemcitabine
Intervention description: 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.
Intervention MeSH terms: Gemcitabine; Mocetinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility 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.