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Olaparib · 1 trial · 2 indications
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...
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Olaparib is an investigational small molecule being studied for use in ovarian cancer, specifically in patients with BRCA-mutated ovarian cancer, recurrent ovarian cancer, or metastatic breast cancer. It is currently in Phase 1 clinical development and is not yet approved for any indication.
Olaparib is being developed by Novartis AG, which trades under the ticker NVS. The drug is currently in Phase 1 clinical development for ovarian cancer and is not yet approved.
Olaparib is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug is not yet available for commercial use.
Olaparib has one completed clinical trial, NCT05258747, a Phase 1 crossover bioequivalence study of olaparib tablets in patients with BRCA-mutated ovarian cancer, recurrent ovarian cancer, or metastatic breast cancer. The trial enrolled 70 female participants in India.
Olaparib is being studied as a generic version of Lynparza (olaparib) tablets. The Phase 1 trial compared olaparib tablets from Lek Pharmaceuticals d.d. with Lynparza tablets from AstraZeneca Pharmaceuticals LP to assess bioequivalence.