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

Phase 2

Completed

• Conditions: Prostate; Pancreatic; Breast; Advanced Tumours; Ovarian
• Interventions: Drug: olaparib

• Registration Number: NCT01078662
• Lead Sponsor: AstraZeneca

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-21
• Study First Submitted: 2010-03-01
• Study First Submitted QC: 2010-03-01
• Study First Posted: 2010-03-02
• Primary Completion: 2012-07-31
• Disposition First Submitted: 2013-05-09
• Disposition First Submitted QC: 2013-05-09
• Disposition First Posted: 2013-05-16
• Results First Submitted: 2015-01-13
• Results First Submitted QC: 2015-05-21
• Results First Posted: 2015-05-22
• Study Completion: 2024-08-12
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-18
• Last Update Posted: 2024-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 298

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	olaparib	Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose recommended by Investigator. Full dose: 300 mg twice daily (bid) or Reduced doses: 200 mg twice daily (bid) or 100 mg twice daily (bid). The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions.

Primary Outcome Measures

Name	Time	Method
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	Tumour response rate is the proportion of patients who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).

Secondary Outcome Measures

Name	Time	Method
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	Progression free survival is defined as the duration from first dose till objective progression or death. In absence of progression or death, the time is calculated from first dose till last evaluable scanning visit.
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	Overall survival rate at 12 months is defined as the proportion of patients who are alive 12 months after date of first dose
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	Duration of response is calculated from the date of first documented response (complete or partial) until date of documented progression (as defined by RECIST 1.1) or death (by any cause) in the absence of disease progression.
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	Objective response rate is the proportion of patients with at least one measurable lesion at baseline, who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1).
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	Overall survival is defined as the duration from first dose till death. In absence of death, the time is calculated from first dose till the date subject last known to be alive.
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	Disease control rate is the proportion of patients with best response of complete or partial response or stable disease according to definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1) till week 16.

Trial Locations

Locations (1)

Research Site; 🇸🇪 Lund, Sweden