Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05258747 | A Crossover Bioequivalence Study of Olaparib Tablets, 150 mg (Lek Pharmaceuticals d.d.) and Lynparza® (Olaparib) Tablets 150 mg (AstraZeneca Pharmaceuticals LP), in Patients With Breast Cancer Gene (BRCA) Mutated Ovarian Cancer, Recurrent Ovarian Cancer or Metastatic Breast Cancer | PHASE1 | COMPLETED | 70 | — | — | Apr 7, 2022 | Oct 20, 2022 | Oct 3, 2024 | 1 | India |
To assess the pharmacokinetics and establish bioequivalence of the Test Product (Olaparib tablets, 150 mg) relative to that of Reference Product (Lynparza® (olaparib) tablets 150 mg) in patients with Breast Cancer Gene (BRCA) mutated ovarian cancer, recurrent ovarian cancer or metastatic breast cancer.
To assess the pharmacokinetics and establish bioequivalence of the Test Product (Olaparib tablets, 150 mg) relative to that of Reference Product (Lynparza® (olaparib) tablets 150 mg) in patients with BRCA mutated ovarian cancer, recurrent ovarian cancer or metastatic breast cancer.
| Arm | Type | Description |
|---|---|---|
| Olaparib tablets, 150 mg, then Lynparza® (olaparib) tablets 150 mg | OTHER | participants will receive 2 x 150 mg Olaparib tablets twice daily for 16 days in a crossover design |
| Lynparza® (olaparib) tablets 150 mg, then Olaparib tablets, 150 mg | OTHER | participants will receive 2 x 150 mg Olaparib tablets twice daily for 16 days in a crossover design |
| Name | Type | Description |
|---|---|---|
| Olaparib tablets, 150 mg | DRUG | Olaparib tablets, 150 mg of Lek Pharmaceuticals d.d., Slovenia |
| Lynparza® (olaparib) tablets 150 mg | DRUG | Lynparza® (olaparib) tablets 150 mg Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, Delaware (DE). |
Inclusion Criteria: \- First-Line Maintenance Treatment of BRCA-mutated Advanced Ovarian Cancer maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in comp...