CTRI/2022/03/040741 [Registered on: 02/03/2022] Trial Registered Prospectively
Last Modified On:
16/05/2023
Post Graduate Thesis
No
Type of Trial
BA/BE
Type of Study
Study Design
Randomized, Crossover Trial
Public Title of Study
A Randomized, open label bioequivalence study of Olaparib tablets, in patients with ovarian cancer, or metastatic breast cancer
Scientific Title of Study
A randomized, open label, multi-centre, two-treatment, two-period, two-sequence, two-stage, multiple dose, steady-state, crossover, bioequivalence study of Olaparib tablets, 150 mg (Lek Pharmaceuticals d.d.) and Lynparza® (olaparib) tablets 150 mg (AstraZeneca Pharmaceuticals LP), in patients with BRCA mutated ovarian cancer, recurrent ovarian cancer or metastatic breast cancer under fasting condition.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
21-VIN-0166 Version 01 dated 20 Sep 2021
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Sumit Arora
Designation
Vice President Clinical Operations
Affiliation
Veeda Clinical Research Ltd.
Address
Veeda Clinical Research Ltd.
Shivalik Plaza, Near I.I.M.
Ambawadi Ahmedabad 380 015, India
Phone: 91 079 3001 3000
Ahmadabad GUJARAT 380015 India
Phone
07930013000
Fax
Email
Sumit.arora@veedacr.com
Details of Contact Person Scientific Query
Name
Dr Ravi Alamchandani
Designation
General Manager
Affiliation
Veeda Clinical Research Ltd.
Address
Veeda Clinical Research Ltd.
Shivalik Plaza, Near I.I.M.
Ambawadi Ahmedabad 380 015, India
Phone: 91 079 3001 3000
Ahmadabad GUJARAT 380015 India
Phone
7930013000
Fax
Email
Ravi.A1950@veedacr.com
Details of Contact Person Public Query
Name
Dr Ravi Alamchandani
Designation
General Manager
Affiliation
Veeda Clinical Research Ltd.
Address
Veeda Clinical Research Ltd.
Shivalik Plaza, Near I.I.M.
Ambawadi Ahmedabad 380 015, India
Phone: 91 079 3001 3000
GUJARAT 380015 India
Phone
7930013000
Fax
Email
Ravi.A1950@veedacr.com
Source of Monetary or Material Support
Lek Pharmaceuticals d.d Verovškova ulica 57
1526 Ljubljana
Slovenia
Primary Sponsor
Name
Lek Pharmaceuticals dd
Address
Verovškova ulica 57
1526 Ljubljana
Slovenia
Tel.No.386 1580 3385
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
Veeda Clinical Research Ltd
Veeda Clinical Research Ltd.,
Shivalik Plaza, Near I.I.M.,
Ambawadi Ahmedabad – 380 015, India
Phone:91 079 3001 3000
1.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 advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. OR Germline BRCA-mutated 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 positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy.
2.Non-smoking, non-pregnant, non-lactating female
3.patient more than or equal to 18 years of age with a body mass index BMI in the range of 18.50 to 30.00 kg per m2 (both inclusive).
4.Able to give written informed consent for participation in the trial and willing to adhere to protocol requirements.
5.Patient having an estimated survival of at least 3 months
6.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 to 2.
7.Women of non child bearing potential with documented evidence of hysterectomy or bilateral salpingectomy or bilateral oophorectomy at least 6 months prior to 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.
ExclusionCriteria
Details
Patients who meet any of the following criteria at screening will not be enrolled in the study:
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.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
An Open list of random numbers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
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 Outcome
Outcome
TimePoints
Number of adverse events
and serious adverse events
To monitor the adverse events
of patients and to assess
safety of each of the two
formulations up to day 24.
Target Sample Size
Total Sample Size="70" Sample Size from India="70" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="70"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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. The primary objective of this study is 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).
Patients will be enrolled after providing written informed consent and treatments will be allocated to
patient by carrying out randomization using statistical techniques.