Platinum sensitive recurrent ovarian cancer
Conditions
Interventions
Product Name: Omnitarg™ (rhuMAb 2C4, pertuzumab)
Product Code: RO4368451
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN:
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - ECOG performance status of 0 or 1. - Life expectancy of = 12 weeks. - Histologically confirmed platinum-sensitive recurrent ovarian cancer, as defined by a progression-free interval of greater than 6 months after completion of a platinum-based regimen - Only one previous regimen which must be platinum-based. - At least one measurable lesion according to RECIST or non-measurable disease. If non-measurable disease must have an elevated CA 125 level of = 2 x ULN documented by two measurements. - Availability of paraffin embedded tumor tissue tumor tissue sample for biomarker assessment - Baseline LVEF = 50% (measured by echocardiography or in exceptional cases by MUGA scan). - For women of childbearing potential, a negative pregnancy test must be available and they must use an effective method of contraception. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - History of CNS metastasis or with clinical evidence of CNS metastases. - Prior radiotherapy. - Inadequate bone marrow, liver function and renal function parameters as described in protocol. Prior treatment with any targeted therapy. - Prior exposure to anthracyclines as defined in protocol. - History of congestive heart failure NYHA grade > 2, unstable angina, evidence of transmural infarction on ECG, poorly controlled hypertension (systolic > 180 mm Hg and/or diastolic > 100 mm Hg), or hemodynamically significant valvular disease. - Patient with serious uncontrolled intercurrent illness - Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary efficacy endpoint is progression-free survival, defined as the time from date of first dose of study drug (study day 1) to documented disease progression or death, whichever occurs earlier. ;Main Objective: To make a preliminary assessment of the efficacy of pertuzumab in combination with carboplatin-based standard chemotherapy as compared to carboplatin-based standard chemotherapy alone, in patients with platinum-sensitive recurrent ovarian cancer, based on progression-free survival. ; Secondary Objective: - To evaluate the objective response rate (ORR) for each treatment arm as defined by RECIST in patients with measurable disease or by CA 125 (GCIG amendment to RECIST) in all patients. - To evaluate the safety profile of pertuzumab in combination with carboplatin-based standard chemotherapy. - To determine the duration of response, time to progression and the overall survival for both treatment arms. - To evaluate biomarkers that may be associated with clinical benefit due to pertuzumab in combination with carboplatin-based chemotherapy. | — |
Countries
Belgium, Hungary, Italy, Spain, United Kingdom
Outcome results
None listed