A Study to Assess Bioequivalence of Olaparib Tablets in Patients with CancerUnder Fasting Conditio
- Conditions
- Health Condition 1: C801- Malignant (primary) neoplasm, unspecified
- Registration Number
- CTRI/2023/09/057694
- Lead Sponsor
- Intas Pharmaceuticals Limited, India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1 Must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study and is willing to participate in the study.2 Man or woman participant must be at least 18 years of age, at the time of signing the informed consent.3 Body mass index (BMI) within the range 17 - 30 kg/m2 (inclusive).4 Participants with following disease who are eligible to received olaparib monotherapy:• Maintenance treatment advanced (FIGO stages III and IV) BRCA1/2-mutated(germline and/or somatic) epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum based chemotherapy; OR• Maintenance treatment of platinum-sensitive relapsed epithelial ovarian, fallopian tube,or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy; OR• Adjuvant treatment of patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy; OR• Patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy; OR • Maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen. OR• Treatment of adult patients with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent; OR • Participant who are eligible to received olaparib based on the tumour-specific NCCN Guidelines®-(current version and any updates thereto).Note: Documented mutation in germline BRCA1/2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function) can be assessed from any previous validated test report available for the participant. If documented BRCA1/2 test results are not available, then participants will be required to undergo BRCA1/2 testing.5 • Participants with established dosing regimen for at least 14 days who already are receiving a stable dose of olaparib tablet (2x150 mg tablets) 300 mg twice daily. OR • Participants not stabilized on olaparib/olaparib treatment naïve participants who are eligible to take olaparib tablet (2x150 mg tablets) 300 mg twice daily for dose stabilization as per PI discretion.6 An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 at screening 7 Participant has recovered from adverse events (baseline or less than or equal to CTCAE Grade 1) due to prior anti-cancer therapy, unless AE(s) is either clinically nonsignificant or stable on supportive therapy or do not constitute a safety risk to the participant as determined by the investigator 8 Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not p
Any potential participant who meets any of the following criteria will be excluded from participating in the study: 1 Documented medical history of uncontrolled, clinically significant intercurrent cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances or any other medical condition(s) for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol specified assessments. 2 Known allergies, hypersensitivity, or intolerance to any of the study interventions, or components/ excipients thereof (refer to the SmPC), or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study.Had major surgical procedure within 4 weeks before screening, or will not have fully recovered from surgical procedure, or has surgical procedure planned during the time the participant is expected to participate in the study. NOTE: Participants with any planned surgical procedure under local anaesthesia only may participate if they agree to seek prior approval from the investigator and such planned procedure is not expected to prevent, limit, or confound the protocol-specified assessments as assessed by the investigator.4 History or current evidence of pneumonitis as assessed by the investigator clinically or radiologically from the most recent scans.5 Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of investigational intervention.6 Positive hepatitis C antibody test result at screening or within 3 months prior to starting investigational intervention. NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA test is obtained. 7 Has known human immunodeficiency virus (HIV) seropositive status, or positive HIV antibody test at screening.8 History of drug or alcohol abuse within 1 year prior to screening or positive test result(s) for alcohol or drugs of abuse (including barbiturates, opiates, cocaine, cannabinoids, amphetamines and benzodiazepines) at baseline.9 History of malignancy except cancer under study within the past 5 years except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for at least 3 years since initiation of that therapy. Note: The time requirement for no evidence of disease for at least 3 years does not apply to the cancer under study for which a participant is enrolled in the study. The time requirement also does not apply to participants basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers who underwent successful definitive resection with no evidence of metastatic disease which is considered cured with minimal risk of recurrence.10 Participants with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the study 11 Past or intended use of any disallowed therapies as noted in Section 6.9,Prior and Concomitant Therapy 12 Received an investigational intervention or used an invasive investigational medical device within 30 da
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method