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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Time Frame:

Imaging will be performed every 6 weeks from the start date of study therapy until documentation of progression or death

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

1775-004

NCT ID:

NCT01357161

Start Date:

July 2011

Completion Date:

September 2014

Related Keywords:

  • Ovarian Cancer
  • Ovarian Neoplasms

Name

Location

Call for Information (Investigational Site 0060)Tampa, Florida  33612
Call for Information (Investigational Site 0005)New Brunswick, New Jersey  08901
Call for Information (Investigational Site 0003)Oklahoma City, Oklahoma  73104
Call for Information (Investigational Site 0008)Houston, Texas  77030
Call for Information (Investigational Site 0004)Seattle, Washington  98104
Call for Information (Investigational Site 0065)Saint Louis, Missouri  63110
Call for Information (Investigational Site 0059)Milwaukee, Wisconsin  53226