Clareo Health | 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)
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)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Merck Sharp & Dohme LLC
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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, adavosertib) 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.
