| General information |
| Database: | DB00525 |
| Objective: | They studied the clinical activity and toxicity of veliparib in ovarian cancer patients carrying a germline BRCA1 or BRCA2 mutation (gBRCA). |
| Authors: | Coleman RL, et al |
| Title: | a phase II evaluation of the potent, highly selective PARP inhibitor veliparib in the treatment of persistent or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who carry a germline BRCA1 or BRCA2 mutation An NRG Oncology/Gynecologic Oncology Group study. |
| Journal: | Gynecol Oncol. |
| Year: | 2015 |
| PMID: | 25818403 |
| Trial Design |
| Clinical Trial Id: | NCT01540565 |
| Agent: | veliparib
|
| Target: | Poly [ADPribose] polymerase1
|
| Cancer Type: | ovarian, primary peritoneal, or fallopian tube carcinoma |
| Cancer Subtype: | primary ovarian, fallopian tube, or primary peritoneal cancer |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase II |
| Key Patients Feature: | Eligible patients had histologic documentation of primary ovarian, fallopian tube, or primary peritoneal cancer by central pathology review[Gynecologic Oncology Group (GOG) Pathology Committee] and carrieda deleterious mutation in BRCA1 or BRCA2 (confirmation was requiredvia clinical report, BRCAnalysis, Myriad Genetics, Salt Lake City, UT).Up to 3 prior cytotoxic regimens were allowed. GOG performance status0-2 was allowed for one previous regimen; 0-1, for 2-3 regimens. Priorbiological therapy was allowed.All patients were required to have measurable disease by Response Evaluation Criteria in Solid Tumors(RECIST 1.1), have discontinued prior chemotherapy (more than and equal to 3 weeks) andhormonal therapy (more than and equal to 1 week) before registration, and recovered fromeffects of recent surgery, radiotherapy, or chemotherapy |
| Biomarker: | germline BRCA1 or BRCA2 mutation |
| Biomark Analysis: | The single agent efficacy and tolerability of veliparib for BRCA mutationassociated recurrent ovarian cancer warrants further investigation. |
| Control Group Info: | single arm |
| Treatment Info: | Veliparib was administered at 400mg orally BID with one cycle being 28days. The twostage Simon design was capable of detecting a 25% response probability with 90% potheyr while controlling alpha=10% (at a 10% assumed null response probability). |
| Primary End Point: | objective tumor response |
| Secondary End Point: | PFS, event free survival (EFS) and overall survival (OS), the proportion of patients who survived progression free/eventfree for at least six months (PFS6/EFS6), and the frequency and severity of treatmentrelated adverse events. |
| Patients Number: | 50 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 8.18 months |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | There was one grade 4 thrombocytopenia. Grade 3 adverse events were: fatigue (n = 3), nausea (2), leukopenia (1), neutropenia (1), dehydration (1), and ALT (1). Grade 2 events >10% were: nausea (46%), fatigue (26%), vomiting (18%), and anemia (14%). |
| Conclusions: | The single agent efficacy and tolerability of veliparib for BRCA mutationassociated recurrent ovarian cancer warrants further investigation. |