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

NCT05258747 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 21-VIN-0166/SAN-0647
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer; Breast Cancer

Keywords

cancer of the ovaries,; female reproductive cancer,; ovarian carcinoma,; female breast cancer

Outcome Measures

Primary Outcomes (2)

• Maximum Plasma Concentration During the Dosing Interval at Steady State (CmaxSS)

  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.

  Pre-dose (0.00 hr) on day 1,6,7,8,14,15 and 16 and Post-dose on day 8 and day 16

• Area Under the Plasma Concentration Versus Time Curve for One Dosing Interval at Steady State (AUC(0-t)ss)

  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.

  Pre-dose (0.00 hr) on day 1,6,7,8,14,15 and 16 and Post-dose on day 8 and day 16

Secondary Outcomes (2)

• Number of Serious Adverse Events

  up to Day 24

• Number of Adverse Events

  up to Day 24

Study Arms (2)

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

Drug: Olaparib tablets, 150 mg; Drug: Lynparza® (olaparib) tablets 150 mg

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

Drug: Olaparib tablets, 150 mg; Drug: Lynparza® (olaparib) tablets 150 mg

Interventions

Olaparib tablets, 150 mg DRUG

Olaparib tablets, 150 mg of Lek Pharmaceuticals d.d., Slovenia

Lynparza® (olaparib) tablets 150 mg, then Olaparib tablets, 150 mg; Olaparib tablets, 150 mg, then Lynparza® (olaparib) tablets 150 mg

Lynparza® (olaparib) tablets 150 mg DRUG

Lynparza® (olaparib) tablets 150 mg Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, Delaware (DE).

Lynparza® (olaparib) tablets 150 mg, then Olaparib tablets, 150 mg; Olaparib tablets, 150 mg, then Lynparza® (olaparib) tablets 150 mg

Eligibility Criteria

• Age: 18 Years - 85 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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 range of 18.50 to 30.00 kg/m\^2 (both inclusive).
• Able to give written informed consent for participation in the trial and willing to adhere to protocol requirements.
• Patient having an estimated survival of at least 3 months
• Adequate organ and bone marrow function based upon the following laboratory criteria at the time of eligibility assessment prior to dosing in period 1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Women of non child bearing potential with documented evidence of hysterectomy / bilateral salpingectomy / bilateral oophorectomy at least 6 months prior to Investigational Medicinal Product (IMP) administration or postmenopausal for at least 12 consecutive months.
• OR Women of child bearing potential must have negative pregnancy test at screening visit and before randomization and must agree to use an effective method of avoiding pregnancy (including oral, transdermal or implanted contraceptives \[any hormonal method in conjunction with a secondary method\], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile \[at least 6 months prior to IMP administration\] sexual partner) for at least 4 weeks prior to IMP administration, during the study and up to 6 months after the last dose of IMP. Cessation of birth control after this point should be discussed with a responsible physician.

You may not qualify if:

• History of known hypersensitivity to olaparib or its components which, in the opinion of the Investigator, would compromise the safety of the patient or the results of the study.
• Usage of strong and moderate CYP3A4 inhibitors (e.g., cimetidine, ciprofloxacin, grapefruit juice) or strong and moderate CYP3A4 inducers (e.g., carbamazepine, phenytoin, St. John"s Wort, rifampicin) within 30 days prior to first dosing in Period 01.
• Pregnant or lactating females.
• History or presence of clinically significant lactose, galactose, or fructose intolerance.

Sponsors & Collaborators

• Sandoz: lead

Study Sites (1)

Sandoz Investigative Site

Vijayawada, Andhra Pradesh, 520002, India

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Breast Neoplasms

Interventions

olaparib; Tablets

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Sandoz Disclosure Office
• Organization: Sandoz

sandoz.disclosure@sandoz.com

+49 8024 / 908 0

Study Officials

• Sandoz

  Sandoz

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: February 28, 2022
• Study Start: April 7, 2022
• Primary Completion: October 20, 2022
• Study Completion: October 20, 2022
• Last Updated: October 3, 2024
• Results First Posted: October 3, 2024

Record last verified: 2024-06

Locations

IN (1)