Ovarian CancerPhase 1NCT05258747
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
A Phase 1 study testing Olaparib tablets, 150 mg and Lynparza® (olaparib) tablets 150 mg in people with Ovarian Cancer and Breast Cancer, run by Sandoz at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Ovarian Cancer, Breast Cancer
- What is being tested?
- Olaparib tablets, 150 mg and Lynparza® (olaparib) tablets 150 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIndia
- Study dates
- 7 Apr 2022to 20 Oct 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
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.
Patients will be enrolled after providing written informed consent and treatments will be allocated to patient by carrying out randomization using statistical techniques.
Patients that are already on a stable dose of Lynparza® (olaparib) tablets and have met the eligibility criteria will be directly randomized for participation in the study.
After randomization patients will receive either test or reference product in a crossover manner based on the randomization schedule. Patients will receive the dose of 300 mg twice daily for 16 days in a crossover design.
In period-I (Day 1 to Day 8), patients will receive either Test product or Reference product for 8 days based on the randomization schedule.
In period-II (Day 9 to Day 16), patients will be switched to the other product for a second period of 8 days.
- Conditions
- Ovarian Cancer, Breast Cancer
- Being tested
- Olaparib tablets, 150 mg, Lynparza® (olaparib) tablets 150 mg
- Keywords
- cancer of the ovaries,, female reproductive cancer,, ovarian carcinoma,, female breast cancer
- Medical subject headings
- Ovarian Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olaparib tablets, 150 mgDrug
Olaparib tablets, 150 mg of Lek Pharmaceuticals d.d., Slovenia
Lynparza® (olaparib) tablets 150 mgDrug
Lynparza® (olaparib) tablets 150 mg Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, Delaware (DE).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Olaparib tablets, 150 mg; Drug: Lynparza® (olaparib) tablets 150 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
To monitor the serious adverse events of patients and to assess safety of each of the two formulations.
Measured: up to Day 24
Number of Adverse Events
To monitor the adverse events of patients and to assess safety of each of the two formulations.
Measured: up to Day 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start7 Apr 2022
- Primary completion20 Oct 2022
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandoz, Study director, Sandoz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258747
- Sponsor's protocol ID
- 21-VIN-0166/SAN-0647
- Status last verified
- Jun 2024
- First submitted
- 17 Feb 2022
- Last updated
- 3 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05258747
- Acronym / sponsor ID
- 21-VIN-0166/SAN-0647
- Conditions
- Ovarian Cancer, Breast Cancer
- Keywords
- cancer of the ovaries,, female reproductive cancer,, ovarian carcinoma,, female breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 28 Feb 2022 (actual)
- Results
- Posted 3 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Patients will be enrolled after providing written informed consent and treatments will be allocated to patient by carrying out randomization using statistical techniques.
Patients that are already on a stable dose of Lynparza® (olaparib) tablets and have met the eligibility criteria will be directly randomized for participation in the study.
After randomization patients will receive either test or reference product in a crossover manner based on the randomization schedule. Patients will receive the dose of 300 mg twice daily for 16 days in a crossover design.
In period-I (Day 1 to Day 8), patients will receive either Test product or Reference product for 8 days based on the randomization schedule.
In period-II (Day 9 to Day 16), patients will be switched to the other product for a second period of 8 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olaparib tablets, 150 mg, then Lynparza® (olaparib) tablets 150 mg | Other | Drug: Olaparib tablets, 150 mg, Drug: Lynparza® (olaparib) tablets 150 mgparticipants 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 | Drug: Olaparib tablets, 150 mg, Drug: Lynparza® (olaparib) tablets 150 mgparticipants will receive 2 x 150 mg Olaparib tablets twice daily for 16 days in a crossover design |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olaparib tablets, 150 mgOlaparib tablets, 150 mg of Lek Pharmaceuticals d.d., Slovenia | Drug | Lynparza® (olaparib) tablets 150 mg, then Olaparib tablets, 150 mg, Olaparib tablets, 150 mg, then Lynparza® (olaparib) tablets 150 mg |
| Lynparza® (olaparib) tablets 150 mgLynparza® (olaparib) tablets 150 mg Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, Delaware (DE). | Drug | Lynparza® (olaparib) tablets 150 mg, then Olaparib tablets, 150 mg, Olaparib tablets, 150 mg, then Lynparza® (olaparib) tablets 150 mg |
Primary outcome
Maximum Plasma Concentration During the Dosing Interval at Steady State (CmaxSS)
Time frame: 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 Breast Cancer Gene (BRCA) mutated ovarian cancer, recurrent ovarian cancer or metastatic breast cancer.
Area Under the Plasma Concentration Versus Time Curve for One Dosing Interval at Steady State (AUC(0-t)ss)
Time frame: 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.
2 secondary outcomes
Number of Serious Adverse Events
Time frame: up to Day 24
Number of Adverse Events
Time frame: up to Day 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandoz study director
Sandoz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Olaparib tablets, 150 mg and Lynparza® (olaparib) tablets 150 mg in people with Ovarian Cancer and Breast Cancer, run by Sandoz at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration During the Dosing Interval at Steady State (CmaxSS) (time frame: Pre-dose (0.00 hr) on day 1,6,7,8,14,15 and 16 and Post-dose on day 8 and day 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.