Health Condition 1: C577- Malignant neoplasm of other specified female genital organs
Conditions
Interventions
Intervention1: Test Product 1: Rucaparib Tablets 300mg: Dose 2 tablets of 300 mg BID for 11 days
Intervention2: Test Product 2: Rucaparib Tablets 300mg: Dose 2 tablets of 300 mg BID for 11 days
Contro
Sponsors
Watson Pharma Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and Female patientâ??s >= 18 years and 2.Understand and voluntarily sign an informed consent form prior to any study related assessments/procedures are conducted. 3.Female patients with histopathologically / cytologically confirmed recurrent epithelial ovarian or fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy and are receiving a daily regimen of Rucaparib. OR 4.Male patient associated-metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy and are receiving daily regimen of Rucaparib. 5.Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, inclusively. 6.Have stable renal function without dialysis for at least 2 months prior to Investigational Product (IP) administration defined by: 7.Have adequate bone marrow function at the screening and randomization visits as defined by: Hemoglobin >= 9 g/dL Absolute neutrophil count (ANC) >= 1.5 x 10x3/uL Platelets >= 100 x 10x3/uL 8.Have adequate hepatic function at the screening visit. 9.Able to adhere to the study visit schedule and other protocol requirements.
Exclusion criteria
Exclusion criteria: 1.Have been participated in another clinical trial or loss of 350ml (1 unit) or more blood within 90 days. 2.Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of Investigational Product. 3.Patients with Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) 4.A positive test result for any of the following: HIV, Hepatitis B surface antigen, Hepatitis C, VDRL, drugs of abuse and breath alcohol test (during check-in). 5.Received treatment with chemotherapy (except Rucaparib), radiation, antibody therapy or other immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors 6.Have ongoing clinically significant adverse event(s) due to prior treatments administered as determined by the investigator. 7.Any surgical procedure 8.Presence of any other condition that may have increased the risk associated with trial participation or may have interfered with the interpretation of trial results, and, in the opinion of the investigator, would make the patient inappropriate for entry into the trial. 9.Untreated or symptomatic central nervous system (CNS) metastases. 10.Any condition that confounds the ability to interpret data from the study 11.Impaired ability to swallow oral medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Equivalence of three formulations (Test 1 vs Reference and Test 2 Vs Reference) in relation to estimation of RucaparibTimepoint: 11 Days (PK Blood Sampling on day 9, day 10, and day 11) | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor safety and tolerability by assessing Adverse events and Laboratory abnormality during the trialTimepoint: During the trial (30 Days) | — |
Countries
India
Contacts
Public ContactMr Prafulla Pawar
Teva pharm India Pvt. Ltd
Outcome results
None listed