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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01078662
Recruitment Status : Active, not recruiting
First Posted : March 2, 2010
Results First Posted : May 22, 2015
Last Update Posted : December 11, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE March 1, 2010
First Posted Date  ICMJE March 2, 2010
Results First Submitted Date  ICMJE January 13, 2015
Results First Posted Date  ICMJE May 22, 2015
Last Update Posted Date December 11, 2019
Actual Study Start Date  ICMJE February 21, 2010
Actual Primary Completion Date July 31, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2015)
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 ]
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).
Original Primary Outcome Measures  ICMJE
 (submitted: March 1, 2010)
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 [ Time Frame: at baseline, then in every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until progression ]
Change History Complete list of historical versions of study NCT01078662 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2015)
  • 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 ]
    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).
  • 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 ]
    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 [ 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 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.
  • 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 ]
    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 [ 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 ]
    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.
  • 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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2010)
  • assessment of objective response rate (ORR), progression free survival (PFS), overall survival (OS), duration of response (DOR) and disease control rate (DCR) [ Time Frame: at baseline, then in every 8 weeks up to 6 months after starting study treatment, then every 12 weeks until progression ]
  • safety and tolerability by collection of adverse events, haematology, clinical chemistry data, vital signs [ Time Frame: at screening, 3x within 1st month and then every 4 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Label Study to Assess Efficacy and Safety of Olaparib in Confirmed Genetic BRCA1 or BRCA2 Mutation Pats
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ovarian
  • Breast
  • Prostate
  • Pancreatic
  • Advanced Tumours
Intervention  ICMJE Drug: olaparib
400mg (8 x 50mg capsules), oral BID until progression of the disease
Study Arms  ICMJE Experimental: 1
olaparib 400mg BD
Intervention: Drug: olaparib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 29, 2017)
299
Original Estimated Enrollment  ICMJE
 (submitted: March 1, 2010)
150
Estimated Study Completion Date  ICMJE December 31, 2020
Actual Primary Completion Date July 31, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 130 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Germany,   Israel,   Spain,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01078662
Other Study ID Numbers  ICMJE D0810C00042
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jane Robertson, BSc, MBCHB, MD AstraZeneca
Principal Investigator: Bella Kaufman, MD Chaim Sheba Medical Centre, Tel Hashomer, Israel
PRS Account AstraZeneca
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP