Trial Outcomes & Findings for 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 (NCT NCT05258747)

Last Updated: 2024-10-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

70 participants

Primary outcome 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

Results posted on

2024-10-03

Participant Flow

Participant milestones

Participant milestones
Measure	Olaparib Tablets, 150 mg, Then Lynparza® (Olaparib) Tablets 150 mg participants will receive 2 x 150 mg Olaparib tablets twice daily for 16 days in a crossover design Olaparib tablets, 150 mg: Olaparib tablets, 150 mg of Lek Pharmaceuticals d.d., Slovenia Lynparza® (olaparib) tablets 150 mg: Lynparza® (olaparib) tablets 150 mg Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, Delaware.	Lynparza® (Olaparib) Tablets 150 mg, Then Olaparib Tablets, 150 mg participants will receive 2 x 150 mg Olaparib tablets twice daily for 16 days in a crossover design Lynparza® (olaparib) tablets 150 mg: Lynparza® (olaparib) tablets 150 mg Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, Delaware. Olaparib tablets, 150 mg: Olaparib tablets, 150 mg of Lek Pharmaceuticals d.d., Slovenia
First Period STARTED	35	35
First Period COMPLETED	35	35
First Period NOT COMPLETED	0	0
Second Period STARTED	35	35
Second Period COMPLETED	34	35
Second Period NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Olaparib Tablets, 150 mg n=59 Participants participants will receive 2 x 150 mg Olaparib tablets twice daily for 16 days in a crossover design Olaparib tablets, 150 mg: Olaparib tablets, 150 mg of Lek Pharmaceuticals d.d., Slovenia	Lynparza® (Olaparib) Tablets 150 mg n=59 Participants participants will receive 2 x 150 mg Olaparib tablets twice daily for 16 days in a crossover design Lynparza® (olaparib) tablets 150 mg: Lynparza® (olaparib) tablets 150 mg Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE
Maximum Plasma Concentration During the Dosing Interval at Steady State (CmaxSS)	10395.085 ng/mL Standard Deviation 3374.4800	9676.278 ng/mL Standard Deviation 2845.1708

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Olaparib Tablets, 150 mg n=59 Participants participants will receive 2 x 150 mg Olaparib tablets twice daily for 16 days in a crossover design Olaparib tablets, 150 mg: Olaparib tablets, 150 mg of Lek Pharmaceuticals d.d., Slovenia	Lynparza® (Olaparib) Tablets 150 mg n=59 Participants participants will receive 2 x 150 mg Olaparib tablets twice daily for 16 days in a crossover design Lynparza® (olaparib) tablets 150 mg: Lynparza® (olaparib) tablets 150 mg Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE
Area Under the Plasma Concentration Versus Time Curve for One Dosing Interval at Steady State (AUC(0-t)ss)	59480.137 hr*ng/mL Standard Deviation 25073.7016	64104.218 hr*ng/mL Standard Deviation 29492.0018

SECONDARY outcome

Timeframe: up to Day 24

To monitor the serious adverse events of patients and to assess safety of each of the two formulations.

Outcome measures

Outcome measures
Measure	Olaparib Tablets, 150 mg n=70 Participants participants will receive 2 x 150 mg Olaparib tablets twice daily for 16 days in a crossover design Olaparib tablets, 150 mg: Olaparib tablets, 150 mg of Lek Pharmaceuticals d.d., Slovenia	Lynparza® (Olaparib) Tablets 150 mg n=69 Participants participants will receive 2 x 150 mg Olaparib tablets twice daily for 16 days in a crossover design Lynparza® (olaparib) tablets 150 mg: Lynparza® (olaparib) tablets 150 mg Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE
Number of Serious Adverse Events	0 Number of Serious Adverse Events	1 Number of Serious Adverse Events

SECONDARY outcome

Timeframe: up to Day 24

To monitor the adverse events of patients and to assess safety of each of the two formulations.

Outcome measures

Outcome measures
Measure	Olaparib Tablets, 150 mg n=70 Participants participants will receive 2 x 150 mg Olaparib tablets twice daily for 16 days in a crossover design Olaparib tablets, 150 mg: Olaparib tablets, 150 mg of Lek Pharmaceuticals d.d., Slovenia	Lynparza® (Olaparib) Tablets 150 mg n=69 Participants participants will receive 2 x 150 mg Olaparib tablets twice daily for 16 days in a crossover design Lynparza® (olaparib) tablets 150 mg: Lynparza® (olaparib) tablets 150 mg Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE
Number of Adverse Events	43 Number of Adverse Events	37 Number of Adverse Events

Adverse Events

Olaparib Tablets, 150 mg

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Lynparza® (Olaparib) Tablets 150 mg

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Olaparib Tablets, 150 mg n=70 participants at risk participants will receive 2 x 150 mg Olaparib tablets twice daily for 16 days in a crossover design Olaparib tablets, 150 mg: Olaparib tablets, 150 mg of Lek Pharmaceuticals d.d., Slovenia Lynparza® (olaparib) tablets 150 mg: Lynparza® (olaparib) tablets 150 mg Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE	Lynparza® (Olaparib) Tablets 150 mg n=69 participants at risk participants will receive 2 x 150 mg Olaparib tablets twice daily for 16 days in a crossover design Lynparza® (olaparib) tablets 150 mg: Lynparza® (olaparib) tablets 150 mg Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE Olaparib tablets, 150 mg: Olaparib tablets, 150 mg of Lek Pharmaceuticals d.d., Slovenia
General disorders Asthenia	0.00% 0/70 • From signing informed consent form till end of the study safety assessments (24 days).	1.4% 1/69 • From signing informed consent form till end of the study safety assessments (24 days).

Other adverse events

Other adverse events
Measure	Olaparib Tablets, 150 mg n=70 participants at risk participants will receive 2 x 150 mg Olaparib tablets twice daily for 16 days in a crossover design Olaparib tablets, 150 mg: Olaparib tablets, 150 mg of Lek Pharmaceuticals d.d., Slovenia Lynparza® (olaparib) tablets 150 mg: Lynparza® (olaparib) tablets 150 mg Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE	Lynparza® (Olaparib) Tablets 150 mg n=69 participants at risk participants will receive 2 x 150 mg Olaparib tablets twice daily for 16 days in a crossover design Lynparza® (olaparib) tablets 150 mg: Lynparza® (olaparib) tablets 150 mg Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE Olaparib tablets, 150 mg: Olaparib tablets, 150 mg of Lek Pharmaceuticals d.d., Slovenia
Blood and lymphatic system disorders Anaemia	10.0% 7/70 • From signing informed consent form till end of the study safety assessments (24 days).	10.1% 7/69 • From signing informed consent form till end of the study safety assessments (24 days).
Gastrointestinal disorders Nausea	8.6% 6/70 • From signing informed consent form till end of the study safety assessments (24 days).	5.8% 4/69 • From signing informed consent form till end of the study safety assessments (24 days).
General disorders Asthenia	5.7% 4/70 • From signing informed consent form till end of the study safety assessments (24 days).	2.9% 2/69 • From signing informed consent form till end of the study safety assessments (24 days).
Investigations White blood cell count decreased	2.9% 2/70 • From signing informed consent form till end of the study safety assessments (24 days).	5.8% 4/69 • From signing informed consent form till end of the study safety assessments (24 days).

Additional Information

Sandoz Disclosure Office

Sandoz

Phone: +49 8024 / 908 0

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Sandoz's agreements with its investigators may vary. However, Sandoz does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Olaparib Tablets, 150 mg, Then Lynparza® (Olaparib) Tablets 150 mg n=35 Participants participants will receive 2 x 150 mg Olaparib tablets twice daily for 16 days in a crossover design Olaparib tablets, 150 mg: Olaparib tablets, 150 mg of Lek Pharmaceuticals d.d., Slovenia Lynparza® (olaparib) tablets 150 mg: Lynparza® (olaparib) tablets 150 mg Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE	Lynparza® (Olaparib) Tablets 150 mg, Then Olaparib Tablets, 150 mg n=35 Participants participants will receive 2 x 150 mg Olaparib tablets twice daily for 16 days in a crossover design Lynparza® (olaparib) tablets 150 mg: Lynparza® (olaparib) tablets 150 mg Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE Olaparib tablets, 150 mg: Olaparib tablets, 150 mg of Lek Pharmaceuticals d.d., Slovenia	Total n=70 Participants Total of all reporting groups
Age, Continuous	47.77 years STANDARD_DEVIATION 8.977 • n=5 Participants	50.74 years STANDARD_DEVIATION 10.590 • n=7 Participants	49.26 years STANDARD_DEVIATION 9.859 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment India	35 participants n=5 Participants	35 participants n=7 Participants	70 participants n=5 Participants
BMI	25.27 Kg/m^2 STANDARD_DEVIATION 3.480 • n=5 Participants	25.62 Kg/m^2 STANDARD_DEVIATION 3.444 • n=7 Participants	25.44 Kg/m^2 STANDARD_DEVIATION 3.441 • n=5 Participants