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

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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.


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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