A Crossover Bioequivalence Study of Olaparib Tablets, 150 mg (Lek Pharmaceuticals d.d.) and Lynpa… (NCT05258747) | Clinical Trial Compass
CompletedPhase 1
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
India70 participantsStarted 2022-04-07
Plain-language summary
This is a two-way crossover bioequivalence study between test and reference product in patients diagnosed with BRCA mutated ovarian cancer, recurrent ovarian cancer or metastatic breast cancer.
Who can participate
Age range18 Years – 85 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 complete or partial response to first-line platinum-based chemotherapy.
OR Maintenance Treatment of Recurrent Ovarian Cancer maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.
OR Advanced Germline BRCA-mutated Ovarian Cancer After 3 or More Lines of Chemotherapy treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.
OR Germline BRCA-mutated Human epidermal growth factor receptor 2 (HER2) -negative Metastatic Breast Cancer treatment of adult 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. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy.
* Non-smoking, non-pregnant, non-lactating female patient ≥18 years of age with a body mass index (BMI) in the ra…
What they're measuring
1
Maximum Plasma Concentration During the Dosing Interval at Steady State (CmaxSS)
Timeframe: Pre-dose (0.00 hr) on day 1,6,7,8,14,15 and 16 and Post-dose on day 8 and day 16
2
Area Under the Plasma Concentration Versus Time Curve for One Dosing Interval at Steady State (AUC(0-t)ss)
Timeframe: Pre-dose (0.00 hr) on day 1,6,7,8,14,15 and 16 and Post-dose on day 8 and day 16