MK1775 in Comb. with Paclitaxel&Carboplatin vs Paclitaxel&Carboplatin Alone

Phase 1

• Conditions: Ovarian, Fallopian Tube, or Peritoneal cancer; MedDRA version: 14.1Level: LLTClassification code 10033130Term: Ovarian cancer NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-002803-13-HU
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-28
• Last Update Posted: 29 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 119

Inclusion Criteria

(1) Patient must have a histologically confirmed non-low grade, non-borderline (low malignant potential) ovarian, fallopian tube, or primary peritoneal cancer that has progressed after paclitaxel / platinum based therapy.
(2) Patients must have platinum sensitive disease. Progression must have occurred 6 months or more after the completion of the most recent platinum based treatment.
(3) Patient is able to provide a baseline tumor sample. The submitted tumor sample must have tested positive for a loss-of-function p53 mutation (as defined in the assay charter) and the result must be documented by a core lab for the study.
(4) Part 1 - Patient may not have received more than two platinum containing treatment regimens for their cancer. Part 2 - Patient may not have received more than three separate regimens of platinum containing treatment for their cancer.
(5) Any biologic therapy or radiation must have been completed four weeks prior to receiving study therapy. With the exception of alopecia, the patient must have recovered to = Grade 1 from adverse events due to previous agents administered. Biologic maintenance therapy (i.e. bevacizumab) is allowable within this six month period. Any biologic maintenance therapy must have been discontinued 28 days prior to the patient starting study therapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 119
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 119

Exclusion Criteria

(1) Patient is currently participating or has participated in a study with an investigational compound or device within 28 days of receiving first dose of study medication.
(2) Patients with active CNS metastases and/or carcinomatous meningitis are excluded. However, patients with CNS metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for 1 month prior to entry as defined as: (1) no evidence of new or enlarging CNS metastasis (2) off steroids or on a stable dose of steroids for at least 2 weeks.
(3) Patient with a primary central nervous system tumor.
(4) Patient has known hypersensitivity or contraindications to the components of potential study therapy (paclitaxel, carboplatin, MK-1775) or its analogs (i.e. cremophor, mannitol, etc). The MK-1775 Investigator Brochure can be referenced for information regarding study therapy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified