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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01078662
First Posted: March 2, 2010
Last Update Posted: August 2, 2017
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.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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

Condition Intervention Phase
Ovarian Breast Prostate Pancreatic Advanced Tumours Drug: olaparib Phase 2

An investigational treatment associated with this study has been approved for sale to the public.   More info ...

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 318
Actual Study Start Date: February 21, 2010
Estimated Study Completion Date: December 29, 2017
Primary Completion Date: July 31, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
olaparib 400mg BD
Drug: olaparib
400mg (8 x 50mg capsules), oral BID until progression of the disease

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 130 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01078662


Locations
United States, California
Research Site
Los Angeles, California, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
Australia
Research Site
Melbourne, Australia
Research Site
Randwick, Australia
Germany
Research Site
Köln, Germany
Israel
Research Site
Haifa, Israel
Research Site
Jerusalem, Israel
Research Site
Petah Tikva, Israel
Research Site
Tel-Hashomer, Israel
Spain
Research Site
Barcelona, Spain
Sweden
Research Site
Lund, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Jane Robertson, BSc, MBCHB, MD AstraZeneca
Principal Investigator: Bella Kaufman, MD Chaim Sheba Medical Centre, Tel Hashomer, Israel
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01078662     History of Changes
Other Study ID Numbers: D0810C00042
First Submitted: March 1, 2010
First Posted: March 2, 2010
Results First Submitted: January 13, 2015
Results First Posted: May 22, 2015
Last Update Posted: August 2, 2017
Last Verified: March 2017

Keywords provided by AstraZeneca:
olaparib
PARP inhibitors
genetic BRCA1 mutation
BRCA2 mutation
solid tumour refractory

Additional relevant MeSH terms:
Olaparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents