To measure the amount and the rate at which olaparib is absorbed from the olaparib 150 mg tablets and becomes available in body of cancer patients (ovarian cancer or breast cancer or pancreatic adenocarcinoma or prostate cancer).
- Conditions
- Health Condition 1: C56- Malignant neoplasm of ovary
- Registration Number
- CTRI/2024/04/065314
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Patients fulfilling all the following inclusion criteria will be included in the study:
1.Male or female patients aged 18-75 years (both inclusive).
2.Patients who are willing and able to provide written informed consent prior to any study-related activities are performed.
3.Patients who are stable on olaparib 300 mg dose (150 mg x 2). Patients who are already taking and are stable on Olaparib 300 mg dose twice daily will enter into screening part I.
OR
Patients who are not stabilized on Olaparib will undergo screening part I and enter in stabilization period for 14 days followed by screening part II. This criteria will be evaluated after stabilization phase and at screening II.
4.Patients with documented diagnosis of either of following;
•Ovarian cancer:
Patients with deleterious or suspected deleterious germline or somatic BRCA mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.
OR
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.
OR
In combination with bevacizumab for the maintenance treatment of adult patients with advanced 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 positive status defined by either a) deleterious or suspected deleterious BRCA mutation, and/or b) genomic instability.
OR
•Breast cancer:
Patients with deleterious or suspected deleterious gBRCAm human epidermal growth factor receptor 2 negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy
OR
Patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting.
OR
Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy.
OR
•Prostate cancer:
Patients with deleterious or suspected deleterious germline or somatic homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer who have progressed following prior treatment with abiraterone or enzalutamide.
OR
In combination abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer.
•Pancreatic cancer
For the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen.
5.Patients who are able to swallow and retain oral medication.
6.Patients with Eastern Cooperative Oncology Group (ECOG) performance status of more than and equal to 2.
7.Patients with life expectancy of more than 90 days.
8.Patients with acceptable
Patients fulfilling any one of the following criteria will be excluded from the study:
1. Patients with known hypersensitivity to Olaparib or to any of the excipients of Test and Reference formulation.
2.Patients with Pneumonitis.
3.Patients currently using or in whom use of any of the prohibited medications is anticipated during study participation.
4.Patients who are breastfeeding and lactating.
5.Patients with known CNS metastasis.
6.Prostate cancer patients with history of venous thromboembolic events.
7.Patients with history of myelodysplastic syndrome or acute myeloid leukemia.
8.Patients who have ongoing grade 3-4 adverse event.
9.Patients with history of any other malignancies in the last 5 years (potential patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible).
10.Patients with any other medical condition or serious intercurrent illness (including cardiovascular, respiratory, metabolic and neurological disorders) that, in the opinion of the Investigator, may make it undesirable for the patients to participate in the study.
11.Any other condition(s) which could significantly interfere with protocol compliance.
12.Patients who have participated in any clinical study within 90 days before the first dose of Investigational Product (i.e., 90 days from last dose of previous study).
13.Patients with loss of more than euqal to 350 mL (1 unit) of blood within 90 days before entering into the study.
14.Patients with positive test for urine drugs of abuse and/or urine alcohol test on the day of every check-in.
15.Patients with history of alcohol dependence, alcohol abuse or drug abuse within past 6 months.
16.Patients who consumes grapefruit/ sweet lime (mosambi) juice within 48 hours prior to first check-in and for the entire period of study.
17.Patients receiving any medications that are strong inhibitors or inducers of the CYP3A enzyme and or any drugs known to interact with Olaparib prior to study or during the study.
18.Patients with positive serology for either Hepatitis B Virus, Hepatitis C Virus, or Human Immunodeficiency Virus.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary PK parameters: Cmax,ss and AUC0-t,ssTimepoint: at day 6
- Secondary Outcome Measures
Name Time Method Cmin,ss, Cavg,ss, Degree of Fluctuation, Swing, Cpd and Tmax,ss.Timepoint: 12 hours