Roll Over Study for Patients Who Have Completed a Previous Oncology Study with Olaparib
- Conditions
- BRCA Mutated Ovarian Cancer Patients, Epithelian ovarian cancer, Metastatic Breast Cancer, Platinum Sensitive Relapsed Ovarian Cancer, Patients with gBRCA mutated metastatic pancreatic cancer,MedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10016180Term: Fallopian tube cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10014733Term: Endometrial cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-003777-26-BG
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 204
1 Provision of signed and dated, written ICF.
2 Patient is currently deriving clinical benefit, as judged by the Investigator, from continued treatment in an AZ parent study using an AstraZeneca (AZ) compound that has met its endpoints or has otherwise stopped.
3 Patient participating in a prior oncology study with an AZ compound in which they received olaparib and are continuing to receive clinical benefit from treatment; the prior study can be an open-label or blinded study, with unblinding at study close.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 97
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 107
1 Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study.
2 Currently receiving treatment with any prohibited medication(s).
3 Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
4 Permanent discontinuation from the parent study due to toxicity or disease progression
(increase in the severity of the disease under study and/or increases in the symptoms of a patient’s condition attributable to the disease, as assessed and documented by the Investigator. Physician-defined progression can be radiological [eg, RECIST] progression or clinical progression).
5 Local access to commercially-available drug at no cost to the patient, as permitted by local/country regulation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To provide continuous study treatment to patients who continue to benefit at the end of a clinical trial, while monitoring safety and tolerability.;Secondary Objective: Not applicable;Primary end point(s): SAEs and AESIs reported until 30 days after the last dose of study drug.;Timepoint(s) of evaluation of this end point: Throughout the study.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable