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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01357161
First received: May 18, 2011
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Drug: MK-1775
Drug: Placebo
Drug: paclitaxel
Drug: carboplatin
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: Imaging will be performed every 6 weeks from the start date of study therapy until documentation of progression or death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate (ORR) [ Time Frame: Imaging will be performed every 6 weeks from the start date of study therapy until documentation of progression or death ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: From randomization (baseline) to death due to any cause ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: July 2011
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-1775 + paclitaxel + carboplatin Drug: MK-1775
MK-1775 capsules, orally, twice a day (BID) for a total of 5 doses starting on Day 1 of each 3-week cycle
Drug: paclitaxel
paclitaxel, intravenous (IV) infusion on Day 1 of each 3-week cycle
Other Name: Taxol
Drug: carboplatin
carboplatin, IV infusion on Day 1 of each 3-week cycle
Other Name: paraplatin
Placebo Comparator: Placebo + paclitaxel + carboplatin Drug: Placebo
placebo to MK-1775, capsule, orally, BID for a total of 5 doses, starting on Day 1 of each 3-week cycle
Drug: paclitaxel
paclitaxel, intravenous (IV) infusion on Day 1 of each 3-week cycle
Other Name: Taxol
Drug: carboplatin
carboplatin, IV infusion on Day 1 of each 3-week cycle
Other Name: paraplatin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01357161     History of Changes
Other Study ID Numbers: 1775-004
Study First Received: May 18, 2011
Last Updated: August 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Carboplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014