CancerPhase 1NCT07371104
Bioequivalence Study of DWZ2501 in Patients With Advanced BRCA-mutated High-grade Ovarian Cancer
A Phase 1 study testing DWZ2501 (Olaparib 150mg) and DWC202510 (Olaparib 150mg) in people with Cancer and Ovarian Cancer, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
A Multicenter, Open-label, Randomized, Multi-dose, 2-sequence, 2-period, Crossover Bioequivalence Study to Comparison of the Pharmacokinetics and Safety of DWZ2501 and DWC202510 in Patients with Advanced BRCA-mutated High-grade Ovarian Cancer Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Cancer, Ovarian Cancer
- What is being tested?
- DWZ2501 (Olaparib 150mg) and DWC202510 (Olaparib 150mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Apr 2026to Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Female subjects aged 19 years or older at the time of obtaining written informed consent.
- 2. Patients with advanced high-grade ovarian cancer harboring a BRCA mutation. 3. Subjects who meet at least one of the following criteria:
- Subjects who have been maintained on an olaparib dosing regimen of 300 mg (two 150 mg tablets) administered orally twice daily for at least 10 consecutive days.
- Subjects who, in the judgment of the principal investigator require a stable dose of olaparib 300 mg (two 150 mg tablets) administered orally twice daily 4. Subjects with an estimated life expectancy of at least 12 weeks. 5. Subjects with a body mass index(BMI) between 18.50 and 30.00 kg/m² at screening.
Who cannot join
- Subjects with a history of hypersensitivity to the investigational product or any of its components.
- Subjects with any of the following concomitant conditions:
- Pneumonitis (2) Myelodysplastic syndrome or acute myeloid leukemia (3) Severe hepatic impairment(Child-Pugh class C). (4) Ongoing active infection or uncontrolled systemic disease (5) Active hepatitis B, hepatitis C, human immunodeficiency virus(HIV) infection, or syphilis.
- 3. Subjects who have received the following drug and non-drug treatments at screening:
- Radiotherapy within 4 weeks prior to screening.
- Other anticancer therapies within 4 weeks prior to screening. 4. Subjects who have undergone major surgery within 4 weeks prior to screening or who have not adequately recovered from a previous major surgery.
- 5. Subjects who have experienced blood loss of approximately 350 mL or more within 12 weeks prior to screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Institutional Review Board of Seoul National University Hospital
Seoul, Jongno-gu, 03080
Kim, 82+220724863, bboddi0311@gmai.com
About this study
Official title: A Multicenter, Open-label, Randomized, Multi-dose, 2-sequence, 2-period, Crossover Bioequivalence Study to Comparison of the Pharmacokinetics and Safety of DWZ2501 and DWC202510 in Patients With Advanced BRCA-mutated High-grade Ovarian Cancer
A Multicenter, Open-label, Randomized, Multi-dose, 2-sequence, 2-period, Crossover Bioequivalence Study to Comparison of the Pharmacokinetics and Safety of DWZ2501 and DWC202510 in Patients with Advanced BRCA-mutated High-grade Ovarian Cancer
- Conditions
- Cancer, Ovarian Cancer
- Being tested
- DWZ2501 (Olaparib 150mg), DWC202510 (Olaparib 150mg)
- Medical subject headings
- Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWZ2501 (Olaparib 150mg)Drug
Subjects receive 600 mg per day, two tablets BID (total 4 tablets), oral administration
DWC202510 (Olaparib 150mg)Drug
Subjects receive 600 mg per day, two tablets BID (total 4 tablets), oral administration
| Study group | Role | What they receive |
|---|---|---|
| Sequence A (Olaparib, RT) | Experimental | Subjects are randomized into two sequence groups. In Sequence A, subjects receive R then T. T: DWZ2501(Olaparib) R: DW202510(Olaparib) Receives: Drug: DWZ2501 (Olaparib 150mg); Drug: DWC202510 (Olaparib 150mg) |
| Sequence B (Olaparib, TR) | Experimental | Subjects are randomized into two sequence groups. In Sequence B, subjects receive T then R.
T: DWZ2501(Olaparib) R: DW202510(Olaparib) Receives: Drug: DWZ2501 (Olaparib 150mg); Drug: DWC202510 (Olaparib 150mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum plasma concentration of olaparib
Measured: Day 8, Day 16 after dose administration
AUCtau
Area under the drug concentration-time curve of olapairb
Measured: Day 8, Day 16 after dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start22 Apr 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Daewoong 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07371104
- Sponsor's protocol ID
- DW_DWZ2501101
- Status last verified
- May 2026
- First submitted
- 19 Jan 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Randomized, Multi-dose, 2-sequence, 2-period, Crossover Bioequivalence Study to Comparison of the Pharmacokinetics and Safety of DWZ2501 and DWC202510 in Patients With Advanced BRCA-mutated High-grade Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07371104
- Acronym / sponsor ID
- DW_DWZ2501101
- Conditions
- Cancer, Ovarian Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 27 Jan 2026 (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.
A Multicenter, Open-label, Randomized, Multi-dose, 2-sequence, 2-period, Crossover Bioequivalence Study to Comparison of the Pharmacokinetics and Safety of DWZ2501 and DWC202510 in Patients with Advanced BRCA-mutated High-grade Ovarian Cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A (Olaparib, RT) | Experimental | Drug: DWZ2501 (Olaparib 150mg), Drug: DWC202510 (Olaparib 150mg)Subjects are randomized into two sequence groups. In Sequence A, subjects receive R then T. T: DWZ2501(Olaparib) R: DW202510(Olaparib) |
| Sequence B (Olaparib, TR) | Experimental | Drug: DWZ2501 (Olaparib 150mg), Drug: DWC202510 (Olaparib 150mg)Subjects are randomized into two sequence groups. In Sequence B, subjects receive T then R. T: DWZ2501(Olaparib) R: DW202510(Olaparib) |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Female subjects aged 19 years or older at the time of obtaining written informed consent.
- 2. Patients with advanced high-grade ovarian cancer harboring a BRCA mutation. 3. Subjects who meet at least one of the following criteria:
- Subjects who have been maintained on an olaparib dosing regimen of 300 mg (two 150 mg tablets) administered orally twice daily for at least 10 consecutive days.
- Subjects who, in the judgment of the principal investigator require a stable dose of olaparib 300 mg (two 150 mg tablets) administered orally twice daily 4. Subjects with an estimated life expectancy of at least 12 weeks. 5. Subjects with a body mass index(BMI) between 18.50 and 30.00 kg/m² at screening.
Key exclusion criteria (7 listed)
- Subjects with a history of hypersensitivity to the investigational product or any of its components.
- Subjects with any of the following concomitant conditions:
- Pneumonitis (2) Myelodysplastic syndrome or acute myeloid leukemia (3) Severe hepatic impairment(Child-Pugh class C). (4) Ongoing active infection or uncontrolled systemic disease (5) Active hepatitis B, hepatitis C, human immunodeficiency virus(HIV) infection, or syphilis.
- Radiotherapy within 4 weeks prior to screening.
- Other anticancer therapies within 4 weeks prior to screening. 4. Subjects who have undergone major surgery within 4 weeks prior to screening or who have not adequately recovered from a previous major surgery.
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 |
|---|---|---|
| DWZ2501 (Olaparib 150mg)Subjects receive 600 mg per day, two tablets BID (total 4 tablets), oral administration | Drug | Sequence A (Olaparib, RT), Sequence B (Olaparib, TR) |
| DWC202510 (Olaparib 150mg)Subjects receive 600 mg per day, two tablets BID (total 4 tablets), oral administration | Drug | Sequence A (Olaparib, RT), Sequence B (Olaparib, TR) |
Primary outcome
Cmax
Time frame: Day 8, Day 16 after dose administration
Maximum plasma concentration of olaparib
AUCtau
Time frame: Day 8, Day 16 after dose administration
Area under the drug concentration-time curve of olapairb
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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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.
Institutional Review Board of Seoul National University Hospital
Seoul, South Korea
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 DWZ2501 (Olaparib 150mg) and DWC202510 (Olaparib 150mg) in people with Cancer and Ovarian Cancer, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 8 May 2026. 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Day 8, Day 16 after dose administration). 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 8 May 2026.