Phase 2
Completed N=136
A Study of Oral Rucaparib in Patients With a Solid Tumor (Phase I) or With gBRCA Mutation Ovarian Cancer (Phase II)
Ovarian Cancer · Fallopian tube cancer · Peritoneal Cancer · Advanced Solid Tumor With Evidence of Germline or Somatic BRCA
Source: ClinicalTrials.gov NCT01482715 ↗
Enrolled (actual)
136
Serious AEs
38.2%
Results posted
Dec 2020
Primary outcomePrimary: Overall Response Rate Per RECIST Version 1.1 (Part 2) — 25; 7 Participants
Summary
Part 1 (Completed Enrollment) - The purpose of the first part of the study was to evaluate the safety of different doses and dosing regimens of oral rucaparib administered daily to patients with solid tumors.
Part 2A (Completed Enrollment) and Part 2B (Completed Enrollment) - The purpose of the second part of the study is to determine the safety and clinical activity of the RP2D of oral rucaparib administered daily to patients with a known deleterious BRCA mutation (germline or somatic).
Part 3 (Completed Enrollment) - The purpose of the third part of the study is to further evaluate PK of higher dose strength tablets at the RP2D in patients with any advanced solid tumor, inclusive of lymphoma, with evidence of a BRCA mutation (germline or somatic).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate Per RECIST Version 1.1 (Part 2) |
25; 7 | — |
| PRIMARY Number of Participants With a Dose Limiting Toxicity (DLT) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY PK Profile of Rucaparib - Cmax (Part 1) |
120; 119; 255; 700; 699; 132 | — |
| PRIMARY PK Profile of Rucaparib - Tmax (Part 1) |
2.5; 1.5; 4; 2.5; 4; 6 | — |
| PRIMARY PK Profile of Rucaparib - AUC Last (Part 1) |
915; 916; 2730; 5820; 7670; 875 | — |
| SECONDARY Progression-free Survival (PFS) According to RECIST v1.1, as Assessed by the Investigator (Part 2) |
260; 280 | — |
| SECONDARY Duration of Response Per RECIST Version 1.1 (Part 2) |
270; 318 | — |
| SECONDARY Overall Survival (Part 2B) |
764 | — |
| SECONDARY Food Effect on PK of Rucaparib - Cmax (Part 1 and Part 3) |
57.6; 424; 585; 71.1; 393; 746 | — |
| SECONDARY Food Effect on PK of Rucaparib - Tmax (Part 1 and Part 3) |
4; 4.09; 4.02; 2.55; 5.95; 7.83 | — |
| SECONDARY Food Effect on PK of Rucaparib - AUC Last (Part 1 and Part 3) |
468; 5410; 7050; 794; 6000; 10900 | — |
| SECONDARY QTcF Value Change From Baseline (Part 1) |
5; 3; 4; 9; 3; 3 | — |
Eligibility Criteria
The following eligibility criteria below pertain to patients enrolling into Part 2B of the study.
Inclusion Criteria
- Have a known deleterious BRCA mutation (gBRCA or sBRCA) (as determined by a local laboratory that has received an international or country-specific, quality standards certification)
- Have evidence of measurable disease as defined by RECIST Version 1.1
- Have sufficient archival FFPE tumor tissue available for planned analyses. Archival tissue from the most recently collected biopsy or debulking surgery should be provided, if available.
- Have a histologically confirmed diagnosis of high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Have received at least three prior chemotherapy regimens and have relapsed disease confirmed by radiologic assessment
Exclusion Criteria
- Active second malignancy, i.e., patient known to have potentially fatal cancer present for which she may be (but not necessarily) currently receiving treatment
a. Patients with a history of malignancy that has been completely treated, with no evidence of that cancer currently, are permitted to enroll in the trial provided all chemotherapy was completed >6 months prior and/or bone marrow transplant (BMT) >2 years prior to first dose of rucaparib
- Prior treatment with any PARP inhibitor.
- Untreated or symptomatic central nervous system (CNS) metastases. Patients with asymptomatic CNS metastases are eligible provided they have been clinically stable for at least 4 weeks.
- Received treatment with chemotherapy, radiation, antibody therapy or other immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, or experimental drugs 14 days prior to first dose of rucaparib and/or ongoing adverse effects from such treatment > NCI CTCAE Grade 1 (Grade 2 non-hematologic toxicity to most recent treatment may be permitted with prior advanced approval from Sponsor).
- Hospitalization for bowel obstruction within 3 months prior to enrollment.
Data sourced from ClinicalTrials.gov (NCT01482715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.