Phase 2
N=298
Open Label Study to Assess Efficacy and Safety of Olaparib in Confirmed Genetic BRCA1 or BRCA2 Mutation Pats
Ovarian · Breast · Prostate · Pancreatic · Advanced Tumours
Bottom Line
View on ClinicalTrials.gov: NCT01078662 ↗Enrolled (actual)
298
Serious AEs
30.2%
Results posted
May 2015
Primary outcome: Primary: Tumour Response Rate — 12.9; 31.1; 21.7; 50 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- olaparib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tumour Response Rate |
12.9; 31.1; 21.7; 50; 8.3; 26.2 | — |
| SECONDARY Objective Response Rate |
13.8; 35.9; 21.7; 57.1; 9.1; 29.3 | — |
| SECONDARY Progression Free Survival |
3.68; 7.03; 4.55; 7.15 | — |
| SECONDARY Overall Survival |
11.01; 16.62; 9.81; 18.38 | — |
| SECONDARY Overall Survival Rate at 12 Months |
44.7; 64.4; 40.9; 50 | — |
| SECONDARY Duration of Response |
204; 225; 134; 326.5; 165; 208 | — |
| SECONDARY Disease Control Rate at Week 16 |
37.1; 58; 47.8; 62.5; 33.3; 52 | — |
Summary
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
Eligibility Criteria
Inclusion Criteria
- Confirmed documented deleterious or suspected deleterious BRCA mutation. (The presence of a loss-of-function germline mutation in the BRCA1 and/or BRCA2 gene must be confirmed prior to consent according to local practice).
- Confirmed malignant solid tumours for which no standard treatment exists
- At least one lesion (measurable and/or non measurable) at baseline that can be accurately assessed by CT/MRI and is suitable for repeated assessment at follow up visits
Exclusion Criteria
- Any previous treatment with a PARP inhibitor, including olaparib
- Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication
- Patients receiving any systematic chemotherapy, radiotherapy (except for palliative reasons) within 2 weeks from the last dose prior to study treatment (or a longer period depending on the defined characteristics of the agents used)
Data sourced from ClinicalTrials.gov (NCT01078662). 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.