Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer MedDRA version: 14.1 Level: PT Classification code 10061269 Term: Malignant peritoneal neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: HLT Classification code 10016181
Conditions
Interventions
Product Name: Rucaparib
Product Code: CO-338
Pharmaceutical Form: Tablet
INN or Proposed INN: Rucaparib camsylate
CAS Number: 283173-50-
Sponsors
Clovis Oncology, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: . Signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form prior to any study-specific evaluation 2. Be ?18 years of age at the time the informed consent form is signed 3. Have a histologically confirmed diagnosis of high-grade epithelial ovarian (serous or endometrioid histology), fallopian tube, or primary peritoneal cancer ? For mixed histology, >50% of the primary tumor must be confirmed to be high-grade serous or endometrioid upon re-review by local pathology 4. Have relapsed/progressive disease as confirmed by radiologic assessment 5. Received prior platinum-based therapy and have platinum-sensitive disease a. Received ?1 prior platinum-based treatment regimen; AND b. Received a platinum-based regimen as their last treatment; continuous or switch maintenance treatment as part of this regimen is permitted; AND c. Was sensitive to the last platinum regimen. Platinum-sensitive disease is defined as documented radiologic progression >6 months after the last dose of platinum administered in the treatment setting. 6. If 100 × 109/L iii. Hemoglobin ?9 g/dL b. Hepatic Function i. Aspartate aminotransferase (AST) and alanine aminotransferase
Exclusion criteria
Exclusion criteria: 1. History of a prior malignancy except: a. Curatively treated non-melanoma skin cancer b. Breast cancer treated curatively >3 years ago, or other solid tumor treated curatively >5 years ago, without evidence of recurrence 2. Prior treatment with any PARP inhibitor, including oral or intravenous rucaparib. Patients who previously received iniparib are eligible 3. Symptomatic and/or untreated central nervous system (CNS) metastases. Patients with asymptomatic previously treated CNS metastases are eligible provided they have been clinically stable for at least 4 weeks 4. Prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with absorption of rucaparib 5. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or history of chronic hepatitis B or C 6. Pregnant or breast feeding. Women of childbearing potential must have a negative serum pregnancy test NCI CTCAE Grade 1 8. Received administration of strong CYP1A2 or CYP3A4 inhibitors ?7 days prior to first dose of rucaparib or have on-going requirements for these medications 9. Non-study related minor surgical procedure ?5 days, or major surgical procedure ?21 days, prior to first dose of rucaparib; in all cases, the patient must be sufficiently recovered and stable before treatment administration 10. Presence of any other condition that may increase the risk associated with study participation or may interfere with the interpretation of study results, and, in the opinion of the investigator, would make the patient inappropriate for entry into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1.To determine the efficacy of rucaparib in homologous recombination deficiency (HRD) subgroups defined by homologous recombination (HR) gene mutations ; Secondary Objective: 1.To assess duration of response (DOR) 2.To evaluate progression-free survival (PFS) 3.To evaluate the safety and tolerability of rucaparib 4.To evaluate steady state trough level pharmacokinetics (PK) ;Primary end point(s): 1. ORR per RECIST v1.1 and GCIG CA-125 criteria. HRD subgroup as determined by a central laboratory next generation sequencing (NGS) test that assesses HR gene mutations; Timepoint(s) of evaluation of this end point: Tumor assessment will be performed at Screening and at the end of every 2nd cycle of treatment (within 7 days prior to the next cycle) and at the end of Treatment visit. If a CT scan is not performed at the End of Treatment visit and the patient did not have a CT scan within 28 days of the End of Treatment visit, a CT scan should be performed at the End of Study visit. CA-125 will be collected at Screening, on Day 1 of every cycle, and at the End of Treatment visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. DOR by RECIST v1.1 2. PFS defined as the occurrence of disease progression according to RECIST v1.1, as assessed by the investigator, or death from any cause 3. The incidence of adverse events (AEs), clinical laboratory abnormalities, and dose modifications 4. Trough (Cmin) level rucaparib concentrations ; Timepoint(s) of evaluation of this end point: 1.DOR assessments will be as per tumor assessments for primary endpoint 2.PFS will be assessed as per tumor assessments for primary endpoint 3.ORR by RECIST will be assessed as per tumor assessments for primary endpoint 4.ORR by GCIG CA-125 criteria will be assessed as per CA-125 assessments for primary endpoint 5.AEs will be recorded at Screening, on Day 1 of each cycle, at end of treatment, and end of study visit (28±3 days after last dose). Ongoing SAEs will be followed to resolution. Clinical laboratory abnormalities will be recorded at Screening, on Day 1 of each cycle, and at end of treatment (urinalysis performed at Screening). Dose modifications to be recorded as needed 6.Samples for rucaparib PK to be taken prior to dosing on Day 15 of Cycle 1 and Day 1 of Cycles 2, 3, and 4 | — |
Countries
Australia, Canada, France, Spain, United Kingdom, United States
Contacts
Public ContactVP Clinical Development
Clovis Oncology UK Ltd
Outcome results
None listed