BRCA Mutated Ovarian Cancer Patients, Epithelian ovarian cancer, Metastatic Breast Cancer, Platinum Sensitive Relapsed Ovarian Cancer, Patients with gBRCA mutated metastatic pancreatic cancer, prostate cancer, endometrium cancer MedDRA version: 20.0 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Or
Conditions
Interventions
Trade Name: Lynparza100 mg film coatedTablet
Product Name: Olaparib 100 mg
Product Code: AZD2281
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: olaparib
CAS Number: 763113-22-0
Current S
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 is as permitted by local/country regulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Belgium, Brazil, Bulgaria, Canada, China, Czechia, Czech Republic, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Netherlands, Norway, Poland, Portugal, Russian Federation, Slovenia, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactInformation Center
AstraZeneca
Outcome results
None listed