Health Condition 1: C00-D49- Neoplasms
Conditions
Sponsors
Intas Pharmaceuticals Limited
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study as described in Appendix 10.1.3 and in this protocol 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 18.5 to 30 kg per m2 (inclusive). 4) Participants with following disease who are eligible to received olaparib monotherapy: Maintenance treatment advanced [International Federation of Gynecology and Obstetrics (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 Participants with germline BRCA1 2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy; OR Participants with germline BRCA1 2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Participants should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless Participants were not suitable for these treatments. Participants 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 Participants 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 Participants 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. Note: Documented mutation in germline/somatic 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 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 (2 into 150 mg tablets) 300 mg twice daily. OR Participants not stabilized on olaparib olaparib treatment na ve participants who are eligible to take olaparib tablet (2 into 150 mg tablets) 300 mg twice daily for dose stabilization and are prescribed Olaparib monotherapy as per the independent judgement of PI as per local practices. 6) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2 at screening. (ECOG PS 2 will be allowed only if it is due to disease indication and not due to comorbidities) 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 inves
Exclusion criteria
Exclusion criteria: 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 SmPC1 and Health Canada Product Monograph) or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study. 3) 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 or Venous Thromboembolic Events (VTE) 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 ribonucleic acid (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) Participants who requ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the bioequivalence of olaparib-Test compared with EU Sourced Olaparib-R1 & Canada Sourced Olaparib-R2 in participants with solid tumours.Timepoint: Pre-dose (0.000) on Day 4, Day 5, Day 6, Day 10, Day 11, Day 12, Day 16, Day 17 and Day 18 Post-dose on Day 6 (Period 1), Day 12 (Period 2) and Day 18 (Period 3) at:0.500, 1.000, 1.500, 2.000, 2.333, 2.667, 3.000, 3.333, 3.667, 4.000, 4.500, 5.000 Post-dose: 6.000, 8.000, 10.000 and 12.000 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| To further characterize the additional multiple-dose pharmacokinetic profile of olaparib-Test compared with EU Sourced Olaparib-R1 & Canada Sourced Olaparib in participants with solid tumours. To compare the safety and tolerability of olaparib-Test compared with EU Sourced Olaparib & Canada Sourced Olaparib in participants with solid tumours.Timepoint: Pre-dose (0.000) on Day 4, Day 5, Day 6, Day 10, Day 11, Day 12, Day 16, Day 17 and Day 18 Post-dose on Day 6 (Period 1), Day 12 (Period 2) and Day 18 (Period 3) at:0.500, 1.000, 1.500, 2.000, 2.333, 2.667, 3.000, 3.333, 3.667, 4.000, 4.500, 5.000 Post-dose: 6.000, 8.000, 10.000 and 12.000 hours | — |
Countries
India
Contacts
Public ContactDr Jogesh Mahajan
Lambda Therapeutic Research Ltd
Outcome results
None listed