NeoplasmsNCT05860530
Bioequivalence Study of Two Olaparib Tablets in Patients With Cancers
A study testing The test olaparib tablet (T) and The reference olaparib tablet (R) in people with Neoplasms, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study aimed to evaluate the pharmacokinetic characteristics and bioequivalence of two olaparib tablets in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neoplasms
- What is being tested?
- The test olaparib tablet (T) and The reference olaparib tablet (R)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2021to 8 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Had BMI 18.0 kg/m^2, and weight ≥ 50 kg for male, or ≥ 45 kg for female
- Patients who were on olaparib treatment, had epithelial ovarian, fallopian tube, or primary peritoneal cancer, or were eligible for olaparib treatment judged investigators
- Had ECOG performance status 0-1
- Had life expectancy >12 weeks
- Had Adequate organ function or clinically irrelevant abnormal result
- Agreed to use adequate contraception from 14 days before treatment initiation to 6 months after last dose
Who cannot join
- Allergic to any component of study drugs
- Had central nervous system metastases (stable and asymptomatic metastases were acceptable)
- Had other malignancy within 5 years
- Had disease affecting swallow or absorption
- Received major surgery within 1 month before study drug administration
- Had major disease
Show all 16Show fewer
- Had continuous grade 3-4 adverse event
- Had drug abuse
- Had (suspected) pneumonitis
- Participated in other clinical trial of drug or device within 1 month
- Lost or donated blood > 200 mL or received blood transfusion within 1 month
- With average alcohol consumption > 14 units/week or cigarette consumption > 20/day within 1 month
- Positive for human immunodeficiency virus, hepatitis B, C, or syphilis test
- Received strong or moderate CYP3A inducer or inhibitor within 3 half-lives of the drug
- Consumed grape fruit juice, or other food or beverage containing caffeine or xanthine
- For female, pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004
About this study
This study aimed to evaluate the pharmacokinetic characteristics and bioequivalence of two olaparib tablets in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- Conditions
- Neoplasms
- Being tested
- The test olaparib tablet (T), The reference olaparib tablet (R)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The test olaparib tablet (T)Drug
The test olaparib tablet (Qilu Pharmaceutical Co., Ltd., Jinan, China) 300mg, every 12 hours
The reference olaparib tablet (R)Drug
The reference olaparib tablet (Lynparza®; AstraZeneca PLC, Cambridge, England, UK) 300mg, every 12 hours
| Study group | Role | What they receive |
|---|---|---|
| Test-reference | Other | Administration order: The test olaparib tablets for 7 days, then the reference olaparib tablets for 7 days. Receives: Drug: The test olaparib tablet (T); Drug: The reference olaparib tablet (R) |
| Reference-test | Other | Administration order: The reference olaparib tablets for 7 days, then the test olaparib tablets for 7 days. Receives: Drug: The test olaparib tablet (T); Drug: The reference olaparib tablet (R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax,ss
The maximum plasma drug concentration at steady state
Measured: Day 7
AUC0-τ
The area under the concentration-time curve between two dosings at steady state
Measured: 0-12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start10 May 2021
- Primary completion8 Sep 2021
- Study completion8 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860530
- Sponsor's protocol ID
- QL-YK3-052-001
- Status last verified
- May 2023
- First submitted
- 8 May 2023
- Last updated
- 1 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioequivalence Study of Two Olaparib Tablets in Patients With Cancers
- ClinicalTrials.gov ID
- NCT05860530
- Acronym / sponsor ID
- QL-YK3-052-001
- Conditions
- Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 May 2021 (actual)
- Primary completion
- 8 Sep 2021 (actual)
- Study completion
- 8 Sep 2021 (actual)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to evaluate the pharmacokinetic characteristics and bioequivalence of two olaparib tablets in patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test-reference | Other | Drug: The test olaparib tablet (T), Drug: The reference olaparib tablet (R)Administration order: The test olaparib tablets for 7 days, then the reference olaparib tablets for 7 days. |
| Reference-test | Other | Drug: The test olaparib tablet (T), Drug: The reference olaparib tablet (R)Administration order: The reference olaparib tablets for 7 days, then the test olaparib tablets for 7 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Had BMI 18.0 kg/m^2, and weight ≥ 50 kg for male, or ≥ 45 kg for female
- Patients who were on olaparib treatment, had epithelial ovarian, fallopian tube, or primary peritoneal cancer, or were eligible for olaparib treatment judged investigators
- Had ECOG performance status 0-1
- Had life expectancy >12 weeks
- Had Adequate organ function or clinically irrelevant abnormal result
Key exclusion criteria (16 listed)
- Allergic to any component of study drugs
- Had central nervous system metastases (stable and asymptomatic metastases were acceptable)
- Had other malignancy within 5 years
- Had disease affecting swallow or absorption
- Received major surgery within 1 month before study drug administration
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 |
|---|---|---|
| The test olaparib tablet (T)The test olaparib tablet (Qilu Pharmaceutical Co., Ltd., Jinan, China) 300mg, every 12 hours | Drug | Reference-test, Test-reference |
| The reference olaparib tablet (R)The reference olaparib tablet (Lynparza®; AstraZeneca PLC, Cambridge, England, UK) 300mg, every 12 hours | Drug | Reference-test, Test-reference |
Primary outcome
Cmax,ss
Time frame: Day 7
The maximum plasma drug concentration at steady state
AUC0-τ
Time frame: 0-12 hours
The area under the concentration-time curve between two dosings at steady state
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The test olaparib tablet (T) and The reference olaparib tablet (R) in people with Neoplasms, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
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 6 inclusion and 16 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 1 Jun 2023. 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 China. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cmax,ss (time frame: Day 7). 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 1 Jun 2023.