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

Prostate Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01078662
• Other study ID #: D0810C00042
• Secondary ID: 2010-022278-15
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 21, 2010
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 298
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

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)

Related Conditions & MeSH terms

• Advanced Tumours
• Breast
• Ovarian
• Pancreatic
• Prostate

Intervention

Drug:
• olaparib
Tablets Oral BID

Locations

Country	Name	City	State
Australia	Research Site	Melbourne
Australia	Research Site	Randwick
Germany	Research Site	Köln
Israel	Research Site	Haifa
Israel	Research Site	Jerusalem
Israel	Research Site	Jerusalem
Israel	Research Site	Petah Tikva
Spain	Research Site	Madrid
Sweden	Research Site	Lund

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Australia,  Germany,  Israel,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumour Response Rate	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).	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	Objective Response Rate	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).	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	Progression Free Survival	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.	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
Secondary	Overall Survival	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.	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
Secondary	Overall Survival Rate at 12 Months	Overall survival rate at 12 months is defined as the proportion of patients who are alive 12 months after date of first dose	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
Secondary	Duration of Response	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.	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
Secondary	Disease Control Rate at 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.	Tumour assessments carried out at baseline ie 28 days before first study drug dose and then at week 8 and week 16

External Links

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