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D0810C00042

Olaparib monotherapy in patients with advanced cancer and a germline BRCA1/2 mutation

Phase 2N = 298NCT01078662

Population
Germline BRCA1/2 mutation with recurrent platinum-resistant ovarian, breast, pancreatic or prostate cancer; 298 patients were treated and evaluable
Design
Multicentre phase 2 study of olaparib 400 mg twice daily in patients with a germline BRCA1/2 mutation and recurrent cancer: platinum-resistant ovarian cancer; breast cancer after at least three chemotherapy regimens for metastatic disease; pancreatic cancer after gemcitabine; or prostate cancer progressing on hormonal and one systemic therapy. Primary efficacy end point tumour response rate.
Primary endpoint
ORR
Arms
  • Olaparib (experimental, n = 298): Olaparib 400 mg twice daily
People
Kaufman B
Show the numbers
Results reported for D0810C00042
EndpointAnalysisOlaparibControlEffect
ORROvarian cancer cohort (platinum-resistant; n=193)primaryKaufman 201531.1% (24.6–38.1%)—Tumour response rate, 60 of 193 patients. Overall across tumour types: 26.2% (78 of 298; 95% CI 21.3-31.6).
Results reported for D0810C00042
EndpointAnalysisOlaparibControlEffect
ORROvarian cancer cohort (platinum-resistant; n=193)primaryKaufman 201531.1% (24.6–38.1%)—Tumour response rate, 60 of 193 patients. Overall across tumour types: 26.2% (78 of 298; 95% CI 21.3-31.6).
Primary publication: Kaufman B, Shapira-Frommer R, Schmutzler RK, Audeh MW, Friedlander M, Balmaña J, et al. Olaparib monotherapy in patients with advanced cancer and a germline BRCA1/2 mutation. J Clin Oncol. 2015;33(3):244-50. PubMedDOI

Appears in

Sources

  1. Kaufman B, Shapira-Frommer R, Schmutzler RK, Audeh MW, Friedlander M, Balmaña J, et al. Olaparib monotherapy in patients with advanced cancer and a germline BRCA1/2 mutation. J Clin Oncol. 2015;33(3):244-50.

    PubMedDOI