advanced (FIGO stage III-IV), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer (who responded to front-line platinum-based chemotherapy) MedDRA version: 20.0 Level: PT Classification code 10016180 Term: Fallopian tube cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10061328 Term: Ovarian epithelial cancer System Organ Class: 10029104 - Neoplasms benign, malign
Conditions
Interventions
Trade Name: Rubraca 200 mg film-coated tablets
Product Name: Rucaparib 200mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Rucaparib
CAS Number: 283173-50-2
Current Sponsor code: CO-338
Sponsors
pharmaand GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Newly diagnosed advanced (FIGO stage III-IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer • Completed cytoreductive surgery, including at least a bilateral salpingo-oophorectomy and partial omentectomy, either prior to chemotherapy (primary surgery) or following neoadjuvant chemotherapy (interval debulking) • Completed first-line platinum-based chemotherapy and surgery with a response, in the opinion of the Investigator • Sufficient tumor tissue for planned analysis • ECOG performance status of 0 or 1 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 650 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 350
Exclusion criteria
Exclusion criteria: • Pure sarcomas or borderline tumors or mucinous tumors • Active second malignancy • Known central nervous system brain metastases • Any prior treatment for ovarian cancer, other than the first-line platinum regimen • Evidence of interstitial lung disease, active pneumonitis, myocarditis or a history of myocarditis • Active, known or suspected autoimmune disease (e.g. autoimmune hepatitis) • Condition requiring active systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate PFS by Response Evaluation Criteria in Solid Tumors (RECIST), as assessed by the investigator (invPFS), using the following separate comparisons: - Monotherapy: Arm B (oral rucaparib+ intravenous [IV] placebo) versus Arm D (placebo [oral and IV) in the HRD and intent-to-treat (ITT) sub/populations - Combination: Arm A (oral rucaparib+ IV nivolumab) versus Arm B (oral rucaparib+IV placebo) in the ITT Population;Secondary Objective: • To evaluate PFS by RECIST, as assessed by the blinded independent central review (BICR; bicrPFS) • To evaluate survival benefit • To evaluate the objective response rate (ORR) and duration of response (DOR), as assessed by the investigator, in patients with measurable disease at baseline • To evaluate safety;Primary end point(s): The primary efficacy endpoint for the study is investigator-determined progression-free survival (PFS) by RECIST v1.1. Investigator-determined PFS is defined as the time from randomization to disease progression, according to RECIST v1.1 criteria as assessed by the investigator, or death due to any cause, whichever occurs first. ;Timepoint(s) of evaluation of this end point: Tumor assessment measurements will be performed at screening, at the end of every 12 weeks of treatment (up to 7 days prior permitted) relative to Cycle 2 Day 1 for the first 3 years and then every 24 weeks thereafter until objective radiological disease progression, and as clinically indicated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoints: Progression-free survival (PFS) as assessed by blinded independent central review (BICR) by RECIST will be tested as a stand-alone secondary endpoint, outside of the step-down procedure for multiplicity adjustment, due to it being supportive of the primary endpoint. BicrPFS is defined as the time from randomization to disease progression, according to RECIST v1.1 criteria as assessed by BICR, or death due to any cause, whichever occurs first. Only tumor scans prior to start of any subsequent anti-cancer treatment are included. Overall survival is defined as the time from randomization to death due to any cause. Analyses of objective response rate (ORR) will be performed in the subgroup of patients with measurable disease at baseline and will be summarized with frequencies and percentages. Duration of response (DOR) will be tested as a stand-alone secondary endpoint, outside of the step-down procedure for multiplicity adjustment. DOR is defined as the interval from the first documentation of objective response (RECIST v1.1) to the earlier of the first documentation of disease progression (per RECIST v1.1) or death from any cause. Safety Analysis: Adverse events, clinical laboratory results, vital signs, ECOG performance status, body weight, and concomitant medications/procedures;Timepoint(s) of evaluation of this end point: Efficacy: as for primary endpoint; (Overall survival is monitored continuously) Safety: at every study visit | — |
Countries
Australia, Belgium, Canada, Czechia, Czech Republic, Denmark, Finland, Germany, Greece, Ireland, Israel, Italy, Japan, Korea, Republic of, New Zealand, Poland, Romania, Russian Federation, Singapore, Spain, Sweden, Taiwan, Türkiye, United Kingdom, United States
Contacts
Public ContactDany Shih
pharmaand GmbH
Outcome results
None listed