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

NCT01078662 | Completed Phase 2 Results

• 2 other identifiers: D0810C000422010-022278-15
• Study Type: interventional
• Target: 298
• Locations: 6 countries
• Sites: 14

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

Conditions

Ovarian; Breast; Prostate; Pancreatic; Advanced Tumours

Keywords

olaparib; PARP inhibitors; genetic BRCA1 mutation; BRCA2 mutation; solid tumour refractory

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• 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

• 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 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

• 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

Study Arms (1)

1

EXPERIMENTAL

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.

Drug: olaparib

Interventions

olaparib DRUG

Tablets Oral BID

Also known as: Lynparza

1

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (14)

Research Site

West Hollywood, California, 90048, United States

Location

Research Site

Philadelphia, Pennsylvania, 19104, United States

Location

Research Site

Melbourne, 3000, Australia

Location

Research Site

Randwick, 2031, Australia

Location

Research Site

Cologne, 50931, Germany

Location

Research Site

Haifa, 31096, Israel

Location

Research Site

Haifa, 35152, Israel

Location

Research Site

Jerusalem, 91031, Israel

Location

Research Site

Jerusalem, 91120, Israel

Location

Research Site

Petah Tikva, 49100, Israel

Location

Research Site

Ramat Gan, 52621, Israel

Location

Research Site

Tel Aviv, Israel

Location

Research Site

Madrid, 08035, Spain

Location

Research Site

Lund, 221 85, Sweden

Location

Related Publications (2)

• Matulonis UA, Penson RT, Domchek SM, Kaufman B, Shapira-Frommer R, Audeh MW, Kaye S, Molife LR, Gelmon KA, Robertson JD, Mann H, Ho TW, Coleman RL. Olaparib monotherapy in patients with advanced relapsed ovarian cancer and a germline BRCA1/2 mutation: a multistudy analysis of response rates and safety. Ann Oncol. 2016 Jun;27(6):1013-1019. doi: 10.1093/annonc/mdw133. Epub 2016 Mar 8.

  PMID: 26961146 DERIVED

• Domchek SM, Aghajanian C, Shapira-Frommer R, Schmutzler RK, Audeh MW, Friedlander M, Balmana J, Mitchell G, Fried G, Stemmer SM, Hubert A, Rosengarten O, Loman N, Robertson JD, Mann H, Kaufman B. Efficacy and safety of olaparib monotherapy in germline BRCA1/2 mutation carriers with advanced ovarian cancer and three or more lines of prior therapy. Gynecol Oncol. 2016 Feb;140(2):199-203. doi: 10.1016/j.ygyno.2015.12.020. Epub 2015 Dec 23.

  PMID: 26723501 DERIVED

Related Links

• Protocol redacted
• CSP Redacted

MeSH Terms

Interventions

olaparib

Results Point of Contact

• Title: Anitra Fielding
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

+44 1625 517178

Study Officials

• Jane Robertson, BSc, MBCHB, MD

  AstraZeneca

  STUDY DIRECTOR

• Bella Kaufman, MD

  Chaim Sheba Medical Centre, Tel Hashomer, Israel

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: March 1, 2010
• First Posted: March 2, 2010
• Study Start: February 21, 2010
• Primary Completion: July 31, 2012
• Study Completion: August 12, 2024
• Last Updated: August 13, 2025
• Results First Posted: May 22, 2015

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

SE (1); IL (7); US (2); ES (1); AU (2); DE (1)