Swedish Medical Center Seattle - CRC 11043: Merck ovarian

CRC 11043: A Randomized, Phase II Study Evaluating MK-1775 in Combination with Paclitaxel and Carboplatin versus Paclitaxel and Carboplatin Alone in Adult Patients with Platinum Sensitive p53 Mutant Ovarian Cancer

Type of Study

Cancer (Oncology) - Fallopian tube, Cancer (Oncology) - Gynecologic, Cancer (Oncology) - Ovarian, Cancer (Oncology) - Peritoneal

Location

Swedish Cancer Institute

Short Description

Purpose: This is a study of the safety and efficacy of MK-1775 in combination with paclitaxel + carboplatin in the treatment of ovarian tumors with the P53 mutation. Participants will be randomly assigned to receive either MK-1775 + paclitaxel + carboplatin or placebo + paclitaxel + carboplatin

Status

Open to Enrollment

Principal Investigator

Saul Rivkin, M.D.

Eligibility Notes

Histologically confirmed non-low grade, non-borderline (low malignant potential) ovarian, fallopian tube, primary peritoneal cancer which has progressed after paclitaxel / platinum-based therapy.
Platinum-sensitive disease. The earliest evidence of progression must have occurred at least 6 months following the completion of the most recent platinum-based treatment.
Must have available tumor sample(s) for central testing.
Performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
No active central nervous system (CNS) metastases and/or carcinomatous meningitis.
No primary CNS tumor.
No known hypersensitivity to the components of potential study therapy (paclitaxel, carboplatin, MK-1775) or its analogs (i.e. cremophor, mannitol, etc).
No required use of medications or products that are metabolized by, or inhibit, or induce Cytochrome P450 3A (CYP3A4).
No ongoing peripheral neuropathies ≥Grade 2 and related to previous treatment.

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