A Study of 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)
Status: | Completed |
---|---|
Conditions: | Ovarian Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/5/2014 |
Start Date: | July 2011 |
End Date: | February 2015 |
Contact: | Toll Free Number |
Phone: | 1-888-577-8839 |
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
This is a study of the safety and efficacy of MK-1775 in combination with paclitaxel +
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 MK-1775 along with
paclitaxel and carboplatin to find the maximum tolerable MK-1775 dose for this combination.
Pharmacokinetics will also be assessed during this period. In Part 2, participants will be
randomly assigned to receive either MK-1775 + paclitaxel + carboplatin or placebo +
paclitaxel + carboplatin.
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 MK-1775 along with
paclitaxel and carboplatin to find the maximum tolerable MK-1775 dose for this combination.
Pharmacokinetics will also be assessed during this period. In Part 2, participants will be
randomly assigned to receive either MK-1775 + paclitaxel + carboplatin or placebo +
paclitaxel + carboplatin.
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.
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