Open Label Study to Assess Efficacy and Safety of Olaparib in Confirmed Genetic BRCA1 or BRCA2 Mutation Pats

Brief summary public domain (ClinicalTrials.gov)

To assess the efficacy of oral olaparib in patients with advanced cancer who have a confirmed genetic BRCA1 and/or BRCA2 mutation, by assessment of tumour response

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Tumour Response Rate [Tumour assessments carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months]. Number, Percentage of participants (95% Confidence Interval). Breast Cancer (n=62): 12.9 (5.74 to 23.85); Ovarian Cancer (n=193): 31.1 (24.64 to 38.13); Pancreatic Cancer (n=23): 21.7 (7.46 to 43.7); Prostate Cancer (n=8): 50 (15.7 to 84.3); Other Cancers (n=12): 8.3 (0.21 to 38.48); All Patients (n=298): 26.2 (21.27 to 31.55).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Objective Response Rate [Tumour assessments carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months]. Number, Percentage of participants (95% Confidence Interval). Breast Cancer (n=58): 13.8 (6.15 to 25.38); Ovarian Cancer (n=167): 35.9 (28.66 to 43.7); Pancreatic Cancer (n=23): 21.7 (7.46 to 43.7); Prostate Cancer (n=7): 57.1 (18.41 to 90.1); Other Cancers (n=11): 9.1 (0.23 to 41.28); All Patients (n=266): 29.3 (23.92 to 35.19).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Progression Free Survival [Tumour assessments are carried out at baseline ie 28 days before first study drug dose and then every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until objective disease progression, assessed maximum up to 29 months]. Median, months (Inter-Quartile Range). Breast Cancer (n=62): 3.68 (1.76 to 7.52); Ovarian Cancer (n=193): 7.03 (3.65 to 11.24); Pancreatic Cancer (n=23): 4.55 (1.81 to 8.21); Prostate Cancer (n=8): 7.15 (2.63 to 17.45).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival [Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed maximum up to 29 months]. Median, months (Inter-Quartile Range). Breast Cancer (n=62): 11.01 (5.68 to 24.18); Ovarian Cancer (n=193): 16.62 (9.43 to NA) [No enough data to calculate upper limit]; Pancreatic Cancer (n=23): 9.81 (3.84 to 16.62); Prostate Cancer (n=8): 18.38 (6.24 to 25.46).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival Rate at 12 Months [Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed maximum up to 29 months]. Number, Percentage of participants. Breast Cancer (n=62): 44.7 (5.68 to 24.18); Ovarian Cancer (n=193): 64.4 (9.43 to NA); Pancreatic Cancer (n=23): 40.9 (3.84 to 16.62); Prostate Cancer (n=8): 50 (6.24 to 25.46).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Duration of Response [From onset of first occurrence of complete or partial response till documented progression or death by any cause in the absence of progression, assessed maximum up to 29 months]. Median, days (Inter-Quartile Range). Breast Cancer (n=8): 204 (149.5 to 405); Ovarian Cancer (n=60): 225 (143 to 410); Pancreatic Cancer (n=5): 134 (131 to 141); Prostate Cancer (n=4): 326.5 (164 to 476); Other Cancers (n=1): 165 (165 to 165); All Patients (n=78): 208 (134 to 410).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Disease Control Rate at Week 16 [Tumour assessments carried out at baseline ie 28 days before first study drug dose and then at week 8 and week 16]. Number, Percentage of participants (95% Confidence Interval). Breast Cancer (n=62): 37.1 (25.16 to 50.31); Ovarian Cancer (n=193): 58 (50.73 to 65.08); Pancreatic Cancer (n=23): 47.8 (26.82 to 69.41); Prostate Cancer (n=8): 62.5 (24.49 to 91.48); Other Cancers (n=12): 33.3 (9.92 to 65.11); All Patients (n=298): 52 (46.18 to 57.81).