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 AM5)
This study is currently recruiting participants.
Verified May 2013 by Merck
Sponsor:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01357161
First received: May 18, 2011
Last updated: May 16, 2013
Last verified: May 2013
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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:
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: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01357161
Contacts
| Contact: Toll Free Number | 1-888-577-8839 |
Locations
| United States, Florida | |
| Call for Information (Investigational Site 0060) | Recruiting |
| Tampa, Florida, United States, 33612 | |
| United States, Missouri | |
| Call for Information (Investigational Site 0065) | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| Call for Information (Investigational Site 0005) | Recruiting |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, Oklahoma | |
| Call for Information (Investigational Site 0003) | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Texas | |
| Call for Information (Investigational Site 0008) | Recruiting |
| Houston, Texas, United States, 77030 | |
| United States, Washington | |
| Call for Information (Investigational Site 0004) | Recruiting |
| Seattle, Washington, United States, 98104 | |
| United States, Wisconsin | |
| Call for Information (Investigational Site 0059) | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Canada, Quebec | |
| Merck Frosst Canada | Recruiting |
| Kirkland, Quebec, Canada, H9H 3L1 | |
| Contact: Mauricio Ede 1-514-428-3044 | |
| Germany | |
| Merck Sharp & Dohme GmbH | Recruiting |
| Haar, Germany | |
| Contact: Kristian Lobner 49 89 4561 1102 | |
| Hungary | |
| MSD Pharma Hungary Kft. | Recruiting |
| Budapest, Hungary | |
| Contact: Simona Martinkova 36 1 457 8522 | |
| Israel | |
| Merck Sharp & Dohme Co. Ltd. | Recruiting |
| Hod Hasharon, Israel | |
| Contact: Ofer Sharon 972�9 9539310 | |
| Russian Federation | |
| Merck Sharp & Dohme IDEA, Inc. | Recruiting |
| Moscow, Russian Federation | |
| Contact: Maria Koroleva 7 0959410000 | |
| Sweden | |
| MSD | Recruiting |
| Sollentuna, Sweden | |
| Contact: Tryggve Ljung 46 (0)70 545 28 66 | |
| United Kingdom | |
| Merck Sharp & Dohme Ltd. | Recruiting |
| Hoddesdon, United Kingdom | |
| Contact: Paul Robinson 44 1992452396 | |
Sponsors and Collaborators
Merck
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01357161 History of Changes |
| Other Study ID Numbers: | 1775-004 |
| Study First Received: | May 18, 2011 |
| Last Updated: | May 16, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 22, 2013