Overview

This trial is active, not recruiting.

Conditions ovarian, breast, prostate, pancreatic, advanced tumours
Treatment olaparib
Phase phase 2
Target PARP
Sponsor AstraZeneca
Start date February 2010
End date July 2012
Trial size 318 participants
Trial identifier NCT01078662, D0810C00042

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
olaparib 400mg BD
olaparib
400mg (8 x 50mg capsules), oral BID until progression of the disease

Primary Outcomes

Measure
Tumour Response Rate
time frame: 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

Secondary Outcomes

Measure
Objective Response Rate
time frame: 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
Progression Free Survival
time frame: 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
Overall Survival
time frame: 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
Overall Survival Rate at 12 Months
time frame: 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
Duration of Response
time frame: 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
Disease Control Rate at Week 16
time frame: Tumour assessments carried out at baseline ie 28 days before first study drug dose and then at week 8 and week 16

Eligibility Criteria

Male or female participants from 18 years up to 130 years old.

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)

Additional Information

Official title A Phase II, Open Label, Non Randomised, Non Comparative, Multicentre Study to Assess the Efficacy and Safety of Olaparib Given Orally Twice Daily in Patients With Advanced Cancers Who Have a Confirmed Genetic BRCA 1 and/or BRCA2 Mutation
Principal investigator Bella Kaufman, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.