Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Study Drug - Olaparib: Olaparib tablet, 300mg Twice Daily, Oral, Duration 182 days
Control Intervention1: nil: nil
Sponsors
AstraZeneca Pharma India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Informed consent 1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 2. Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses. 3. Subjects = 18 years of age Type of subject and disease characteristics 4. Subjects receiving olaparib for the following indications in ovarian cancer: for the maintenance treatment of adult subjects with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy 5. Subjects receiving olaparib for the following indication in breast cancer: in subjects with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Subjects with HR-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment Sex 6. Only Females will be recruited Reproduction 7. Negative pregnancy test (urine or serum) for female subjects of childbearing potential at least 72 hours prior to beginning treatment. 8. Female subjects of childbearing potential must be willing to use an adequate method of contraception for the course of the study and through 120 days after the last dose of trial treatment. Organ function 9. Have adequate organ function as defined in Table X. Specimens must be collected within 10 days prior to the start of trial treatment. Hematological Absolute neutrophil count (ANC) =1500/µL Platelets =100,000/µL Hemoglobin =9.0 g/dL or =5.6 mmol/L Renal Creatinine OR Mesaured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) =1.5 x ULN OR =30 ml/min for subject with creatinine levels >1.5 x institutional ULN Hepatic Total bilirubin =1.5 x ULN OR direct bilirubin =ULN for subjects with total bilirubin levels >1.5 x ULN AST (SGOT) and ALT (SGPT) =2.5 x ULN OR =5 x ULN for subjects with liver metastases Coagulation International normalized ratio (INR) or prothrombin time (PT) Activated partial thromboplastin time (aPTT) =1.5 x ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
Exclusion criteria
Exclusion criteria: Medical conditions 1. Subjects with either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug OR 2. pregnant and/or lactating women OR 3. Patients with a previously or currently diagnosed MDS/ AML or pneumonitis OR 4. Patients who have not recovered sufficiently from prior surgery or anticancer treatment OR 5. Patients who have known history of hepatitis B or hepatitis C OR 6. Patients with active infection such as TB Prior/concurrent clinical study experience 7. Participation in another clinical study with a study drug administered in the last 3 months Other exclusions 8. Judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements. 9. Previous enrolment in the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety of olaparib in Indian subjects with platinum sensitive relapsed ovarian cancer who are in complete or partial response following platinum-based chemotherapy, and HER – 2 negative metastatic breast cancer with germline BRCA1/2 mutation. Timepoint: End of the study period (12 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| nilTimepoint: nil | — |
Countries
India
Contacts
Public ContactAmit Kumar
AstraZeneca Pharma India Ltd
Outcome results
None listed