Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Olaparib tablets 150 mg
: The randomized Participants will receive the Test product in a crossover manner as per the randomization schedule. Each participant will receive a dose of 300
Sponsors
M/s Hetero Labs Limited
Clians Labs PrivateLimited
Eligibility
Inclusion criteria
Inclusion criteria: Participants must fulfil all the following criteria to be considered for inclusion into the study. 1.Eligible patient populations include any one of the following: A. Adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (for use as maintenance treatment). Or B. In combination with bevacizumab for the maintenance treatment of adult patients with advanced (FIGO stage III and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy, and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either: Ba. a deleterious or suspected deleterious BRCA mutation, and/or Bb. genomic instability. Or C. Adult patients with deleterious or suspected deleterious germline or somatic BRCA mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy, for use as maintenance treatment. Or D. Adjuvant treatment: For the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA mutated (g BRC Am), HER2 negative, high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Or E. Adult patients with deleterious or suspected deleterious g BRC Am, HER2 negative metastatic breast cancer, previously treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. E .a. If Patients with hormone receptor (HR)-positive breast cancer should have received prior endocrine therapy or be considered inappropriate for endocrine therapy. Or F. Adult patients with deleterious or suspected deleterious g BRC Am metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first line platinum based chemotherapy regimen. Or G. Adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene mutated metastatic castration resistant prostate cancer (m CRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Or H. Adult patients with deleterious or suspected deleterious BRCA-mutated (BRC Am) metastatic castration-resistant prostate cancer (m CRPC), in combination with abiraterone and prednisone or prednisolone. AND I. Participants who are already receiving a stable dose of Ola pa rib (300 mg tablets) twice daily for at least 14 days. 2. Able to take oral medication without crushing, dissolving, or chewing tablets. 3. Eastern Cooperative Oncology Group (ECOG) performance status less than 2 4. Absence of blood transfusion in the 28 days prior to randomization 5. Willing and able to give written informed consent. 6. Absence of disease markers of HIV 1 and 2, hepatitis B and C. 7. Able to communicate effectively with study personnel. 8. Patients may have received prior radiation therapy or surgery. However, at least 28 days must have elapsed since completion of
Exclusion criteria
Exclusion criteria: The Participants will be excluded based on the following criteria. 1. History of addiction to any recreational drug or drug dependence. 2. Psychiatric disorder that interferes with the Participant s ability to comply with the study protocol. 3. Patient found positive for HIV, Hepatitis B surface antigen or Hepatitis C antibody at screening. 4. Have ongoing clinically significant adverse events due to prior treatments administered, as determined by investigator. 5. Patients with pneumonitis 6. Patient with severe hepatic impairment (Child Pugh classification category C). 7. History of long QT syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The bioequivalence of Test product (T) Olaparib tablets 150 mg of Hetero Labs Limited, India with Reference product (R) LYNPARZA 150 mg film tabletten (Olaparib) of AstraZeneca AB SE-151 85 Sodertalje Schweden will be assessed by a statistical comparison of various pharmacokinetic parameters derived from the plasma concentration-time curves of Olaparib.Timepoint: The Pharmacokinetic parameters derived from the plasma concentration-time curves of Olaparib will be done as follows: In each study period the blood samples will be collected as following. On 6, 7, 8, 14, 15 and 16: A single pre-dose [00.00 hour] blood sample of 4 mL each will be collected within 05 minutes prior to dosing of morning doses. On Day 8 (morning dose) and 16 (morning dose): The post dose blood samples of 4 mL each will be drawn at 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.33, 2.67, 3.00, 4.00, 5.00, 6.00, 8.00, 10.00 and 12.00 hours in each study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| NilTimepoint: Nil | — |
Countries
India
Contacts
Public ContactDr Raju Lingumpelly
Clians Labs Private Limited
Outcome results
None listed