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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)
Not Recruiting
Trial ID: NCT01357161
Purpose
This is a study of the safety and efficacy of adavosertib in combination with paclitaxel plus
carboplatin in the treatment of ovarian, fallopian tube, and primary peritoneal tumors with
the P53 mutation. In Part 1, a small group of participants will receive adavosertib along
with paclitaxel plus carboplatin to establish the tolerability of adavosertib with this
combination. In Part 2, participants will be randomly assigned to receive either adavosertib
plus paclitaxel and carboplatin OR placebo plus paclitaxel and carboplatin to assess efficacy
of adavosertib compared to placebo. The primary hypothesis of the study (Part 2) is that
administration of adavosertib in combination with paclitaxel plus carboplatin in participants
with platinum sensitive p53 mutant ovarian cancer will result in improvement in progression
free survival (PFS) per enhanced Response Evaluation Criteria In Solid Tumors version 1.1
(enhanced RECIST 1.1) compared to participants treated with paclitaxel plus carboplatin
alone.
Official Title
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
Stanford Investigator(s)
Jonathan S. Berek, MD, MMSc
Laurie Kraus Lacob Professor
Eligibility
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, 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.
Intervention(s):
drug: Placebo
drug: paclitaxel
drug: carboplatin
drug: adavosertib
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061