A Study of Adavosertib (MK-1775) in Combination With Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin Alone for Participants With Platinum-Sensitive Ovarian Tumors With the P53 Gene Mutation (MK-1775-004)
Ovarian Cancer
About this trial
This is an interventional treatment trial for Ovarian Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed non-low grade, non-borderline (low malignant potential) ovarian, fallopian tube, or primary peritoneal cancer which has progressed after paclitaxel / platinum-based therapy.
- Platinum-sensitive disease. Radiological progression must have occurred 6 months or more after the completion of the most recent platinum-based treatment.
- Measurable disease.
- Available tumor sample(s).
- Performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Adequate organ function.
Exclusion Criteria:
- Pregnancy or the intention to become pregnant during the course of the study.
- Participation in a study with an investigational compound or device within 28 days of receiving first dose of study medication.
- Active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Primary CNS tumor.
- Known hypersensitivity or contraindications to the components of potential study therapy (paclitaxel, carboplatin, MK-1775) or its analogs (i.e. cremophor, mannitol, etc.).
- Participant requires the use of medications or products that are metabolized by, or inhibit, or induce Cytochrome P450 3A (CYP3A4).
- Ongoing peripheral neuropathies ≥Grade 2 and related to previous treatment.
- Known psychiatric or substance abuse disorders.
- Regular use (including "recreational use") of any illicit drugs or recent history (within the last year) of drug or alcohol abuse.
- HIV positive.
- Active Hepatitis B or C.
- Symptomatic ascites or pleural effusion.
- Clinical history suggestive of Li Fraumeni Syndrome.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Part 1: adavosertib 225 mg + paclitaxel +carboplatin
Part 2: adavosertib 225 mg + paclitaxel +carboplatin
Part 2: Placebo + paclitaxel +carboplatin
During the open-label run-in, participants receive 225 mg adavosertib twice daily (BID) starting on Day 1 of Cycle 1 (cycle=21 days) for a total of 5 doses. Participants receive adavosertib in combination with paclitaxel (175 mg/m2) and carboplatin (area under the curve [AUC] 5).
During Part 2, participants receive 225 mg adavosertib BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants receive adavosertib in combination with paclitaxel (175 mg/m2) and carboplatin (AUC 5).
During Part 2, participants receive matched placebo to adavosertib BID starting on Day 1 of each 21 day cycle for a total of 5 doses. Participants receive placebo in combination with paclitaxel (175 mg/m2) and carboplatin (AUC 5).