Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer

Status: Recruiting
Phase:
Diagnosis: GYN: Ovarian, Fallopian, Peritoneal Cancer
NCT ID: NCT01936363 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-376

 

This is a double blind, randomized, placebo-controlled, 2-arm, Phase 2 trial investigating the efficacy and safety of combination therapy of pimasertib plus SAR245409 and pimasertib placebo administered once per day compared to pimasertib administered twice per day plus SAR245409 placebo administered once per day in subjects with previously treated unresectable low-grade ovarian cancer.

 

Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital

Overall PI:
Joyce Liu, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Michael Birrer, MD, PhD, Massachusetts General Hospital

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Christin Whalen, 617-582-7738, cwhalen@partners.org

Eligibility Criteria

Inclusion Criteria: - The female subject has a diagnosis of one of the following: a) low-grade serous ovarian or peritoneal carcinoma, or grade 1 serous ovarian or peritoneal carcinoma or well-differentiated serous ovarian or peritoneal carcinoma or b) serous borderline ovarian or peritoneal tumor, ovarian or peritoneal tumor of low-malignant potential, ovarian or peritoneal atypical proliferative serous tumor that recurs as low grade serous carcinoma or has invasive peritoneal implants. - The subject had at least one prior line of systemic therapy and has a tumor, which is not amenable to potentially curative surgical resection. - The subject has measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. - The subject is at least 18 years old. - The subject has read and understood the written informed consent form (ICF) and is willing and able to give informed consent, fully understands the requirements of the trial and is willing to comply with all trial visits and assessments, including completion of patient-reported measures. Consent must be given before any trial related activities. - Subjects of childbearing potential must have a negative serum pregnancy test at the screening visit. - Subjects of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for 2 weeks prior to screening, during and at least 4 weeks after the last dose of trial medication. - Other protocol defined inclusion criteria may apply. Exclusion Criteria: - The subject has previously been treated with a PI3K inhibitor and taken off treatment due to treatment related AEs. - The subject has been previously treated with a Mitogen-activated protein/extracellular signal-regulated kinase (MEK) inhibitor. - The subject has received chemotherapy, immunotherapy, hormonal therapy, biologic therapy, or any other anti-cancer therapy within 28 days or within 5 times the half life of a relevant agent prior to day 1 of trial drug treatment, whichever is shorter, or has been treated with nitrosoureas or mitomycin C within the last 6 weeks. - The subject has not recovered from toxicity due to prior therapy to Baseline level or National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI CTCAE v4.0) Grade 1 or less (except alopecia). - The subject has poor organ and marrow function as defined in the protocol. - The subject has creatine phosphokinase (CPK) elevation NCI CTCAE grade >=2, and/or a previous history of myositis or rhabdomyolysis. - The subject has difficulty swallowing, malabsorption or other chronic gastrointestinal disease or conditions that may hamper compliance and/or absorption of the trial drug. - The subject has a history of delayed healing/open wounds or diabetic ulcers. - The subject has a history of congestive heart failure, unstable angina, myocardial infarction, cardiac conduction abnormalities including corrected QT interval prolongation of > 480ms or a pacemaker, clinically relevant impaired cardiovascular function (New York Heart Association (NYHA) class III/IV) or stroke within 3 months prior to enrollment. - The subject has a history of retinal degenerative disease (hereditary retinal degeneration or age-related macular degeneration), uveitis or retinal vein occlusion (RVO), or has other relevant abnormalities identified on screening opthalmologic examination, which may increase the risk of serous retinal detachment (SRD) or RVO. - The subject has a history of uncontrolled intercurrent illness including but not limited to an active infection, hypertension, or uncontrolled diabetes (e.g. glycosylated hemoglobin >= 8%) that would limit compliance with treatment requirements. - Other protocol defined exclusion criteria may apply.
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