Advanced High-grade Ovarian CancerPhase 1/2NCT03333915
Study of the Efficacy, Safety and Pharmacokinetics of Pamiparib (BGB-290) in Participants With Advanced Solid Tumors
A Phase 1/2 study testing Pamiparib in people with Advanced High-grade Ovarian Cancer and Triple Negative Breast Cancer, run by BeiGene at 6 sites in China.
Trial summary
This study is designed to evaluate the safety, tolerability, PKharmacokinetic profile and treatment effect of pamiparib in Chinese participants with advanced high-grade ovarian cancer (including fallopian cancer or primary peritoneal cancer) and triple negative breast cancer in phase I, and to evaluate the efficacy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced High-grade Ovarian Cancer, Triple Negative Breast Cancer
- What is being tested?
- Pamiparib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 6 sitesChina
- Study dates
- 21 Dec 2016to 11 Aug 2021
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants have voluntarily agreed to participate by giving written informed consent.
- Age 18 years (including 18 years) on the day of signing informed consent.
- Participants meet the following eligibility criteria for the corresponding part of the study: 1) In Phase 1 portion: The participants must have a histologically or cytologically confirmed locally advanced or metastatic cancer, either triple-negative breast cancer or epithelial, non-mucinous, high-grade ovarian cancer (including fallopian cancer, or primary peritoneal cancer), for which no effective standard therapy is available.
- 2) In Phase 2 portion: Participants who have histologically or cytologically confirmed high-grade epithelial ovarian cancer (including fallopian cancer or primary peritoneal cancer), harboring germline BRCA1/2 mutation 4. Participants must have measurable disease as defined per the RECIST, version 1.1.
- 5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
Who cannot join
- Participants who have been treated with chemotherapy, biologic therapy, immunotherapy, investigational agent, anti-cancer Chinese medicine, or anticancer herbal remedies ≤ 14 days (or ≤5 half-lives, whichever is shorter) prior to starting study drug, or who have not adequately recovered from the side effects of such therapy.
- Participants who have undergone major surgery for any cause ≤ 4 weeks prior to starting study drug. Participants must have adequately recovered from the previous treatment and have a stable clinical condition before entering the study.
- Participants who have undergone radiotherapy for any cause ≤ 14 days prior to starting study drug. Participants must have adequately recovered from the previous treatment and have a stable clinical condition before entering the study.
- Untreated and/or active brain metastases.
- Prior therapies targeting poly (ADP-ribose) polymerase (PARP).
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Hunan Cancer Hospital
Changsha, Hunan, 410013
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000
Henan Cancer Hospital
Zhengzhou, Henan, 450000
About this study
Official title: An Open Label, Multi-Center Phase I/II Study to Evaluate Efficacy and Safety of BGB-290 in Chinese Subjects With Advanced Ovarian Cancer, Fallopian Cancer, and Primary Peritoneal Cancer or Advanced Triple Negative Breast Cancer
This study is designed to evaluate the safety, tolerability, PKharmacokinetic profile and treatment effect of pamiparib in Chinese participants with advanced high-grade ovarian cancer (including fallopian cancer or primary peritoneal cancer) and triple negative breast cancer in phase I, and to evaluate the efficacy and safety of pamiparib in Chinese participants with recurrent epithelial ovarian cancer (including fallopian cancer or primary peritoneal cancer), harboring germline breast cancer susceptibility gene 1/gene 2 (BRCA1/2) mutation in phase II.
- Being tested
- Pamiparib
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PamiparibDrug
Also called BGB-290
Pamiparib is provided as oral capsules
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: 20 milligram (mg) pamiparib | Experimental | 20 mg pamiparib twice a day for 21 days Receives: Drug: Pamiparib |
| Phase 1 : 40 mg pamiparib | Experimental | 40 mg pamiparib twice a day for 21 days Receives: Drug: Pamiparib |
| 60 mg pamiparib | Experimental | 60 mg pamiparib twice a day for 21 days Receives: Drug: Pamiparib |
| 60 mg pamiparib in platinum-sensitive ovarian cancer (PSOC) | Experimental | 60 mg pamiparib twice a day until occurrence of unacceptable toxicities, disease progression, withdrawal of consent or investigator discretion Receives: Drug: Pamiparib |
| 60 mg pamiparib in platinum resistant ovarian cancer (PROC) | Experimental | 60 mg pamiparib twice a day until occurrence of unacceptable toxicities, disease progression, withdrawal of consent or investigator discretion Receives: Drug: Pamiparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Number of Participants With Treatment- Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
A TEAE is defined as an adverse event (AE) that had an onset date on or after the first dose of study drug up to 30 days following study drug discontinuation or was worsening in severity from baseline (pretreatment).
Measured: From first dose to within 30 days of last dose of pamiparib (approximately 36 months)
Phase 1: Number of Participants With Clinically Significant Abnormalities in Physical Examinations and Electrocardiograms (ECGs)
Measured: From first dose to within 30 days of last dose of pamiparib (approximately 36 months)
Phase 2: Objective Response Rate (ORR) in High Grade Ovarian Cancer (HGOC) Both PSOC and PROC as Assessed by Independent Radiology Review Committee (IRC)
ORR is defined as the percentage of participants with confirmed Complete Response or Partial Response
Measured: Up to approximately 2 years and 8 months
Secondary outcomes (23)
Phase I: Maximum Observed Plasma Concentration (Cmax)
Measured: Cycle 1 Day 1 and Day 10 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Phase I: Time to Reach Cmax (Tmax)
Measured: Cycle 1 Day 1 and Day 10 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Phase I: Terminal Elimination Half-life (t1/2)
Measured: Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Phase I: Apparent Clearance (CL/F)
Measured: Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Phase 1: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf)
Measured: Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Phase I: Apparent Volume of Distribution During Terminal Phase (Vz/F)
Measured: Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Phase I: Confirmed Objective Response Rate (ORR) as Assessed by the Investigator Per RECIST v1.1
ORR is defined as the percentage of participants with confirmed Complete Response (CR) or Partial Response (PR)
Measured: Up to approximately 36 months
Phase 1: Disease Control Rate (DCR) Assessed by the Investigator Per RECIST v1.1
DCR is defined as the percentage of participants with best overall response (BOR) of CR, PR and stable disease (SD)
Measured: Up to approximately 36 months
Phase I: Clinical Benefit Rate (CBR) Assessed by the Investigator Per RECIST v1.1
CBR is defined as percentage of participants with best overall response of CR, PR and stable disease (SD)≥24 weeks
Measured: Up to approximately 36 months
Phase 1: Duration of Response (DOR) as Assessed by Investigator Per RECIST v1.1
DOR is defined as the time from the first determination of a confirmed overall response until the first documentation of progression or death, whichever comes first
Measured: Up to approximately 36 months
Phase I : Progression Free Survival (PFS)
PFS is defined as the time from first dose of study medication to the first documented disease progression or death due to any cause, whichever occurs first
Measured: Up to approximately 36 months
Phase 2: Objective Response Rate (ORR) by Investigator Per RECIST v1.1
ORR is defined as the percentage of participants with confirmed Complete Response or Partial Response
Measured: Up to approximately 3 years and 8 months
Phase 2: Disease Control Rate by Investigator Per RECIST v1.1
DCR is defined as the percentage of participants with best overall response (BOR) of CR, PR and stable disease (SD)
Measured: Up to approximately 3 years and 8 months
Phase 2: Clinical Benefit Rate by Investigator Per RECIST v1.1
CBR is defined as percentage of participants with best overall response of CR, PR and stable disease (SD)≥24 weeks
Measured: Up to approximately 3 years and 8 months
Phase 2: Carcinoma Antigen-125 (C(A-125) Response Rate by Gynecologic Cancer Inter Group (GCIG )Criteria
CA-125 response is defined the percentage of participants with at least 50% reduction in CA-125 levels from pre-treatment sample
Measured: Up to approximately 3 years and 8 months
Phase 2: Duration of Response as Assessed by Investigator Per RECIST v1.1
DOR is defined as the time from the first determination of a confirmed overall response until the first documentation of progression or death, whichever comes first
Measured: Up to approximately 3 years and 8 months
Phase 2: Progression Free Survival as Assessed by the Investigator Per RECIST v1.1
PFS is defined as the time from first dose of study medication to the first documented disease progression or death due to any cause, whichever occurs first
Measured: Up to approximately 3 years and 8 months
Phase 2: Overall Survival (OS) as Assessed by Investigator
OS is defined as time from the first dose of study medication to the date of death due to any cause
Measured: Up to approximately 3 years and 8 months
Phase 2: Number of Participants With Treatment- Emergent Adverse Events and Serious Adverse Events
A TEAE is defined as an adverse event (AE) that had an onset date on or after the first dose of study drug up to 30 days following study drug discontinuation or was worsening in severity from baseline (pretreatment). All clinically significant abnormalities in physical examinations, laboratory tests and ECGs are reported as adverse events (AE) in the AE section.
Measured: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Phase 2: Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post-dose (AUC0-12)
Measured: Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Phase 2: Maximum Observed Plasma Concentration (Cmax)
Measured: Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Phase 2: Time to Reach Cmax (Tmax)
Measured: Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Phase 2: Area Under the Plasma Concentration-time Curve From 0 to the 9 Hours Post-dose (AUC0-9)
Measured: Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start21 Dec 2016
- Primary completion24 Aug 2020
- Study completion11 Aug 2021
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 Advanced High-grade Ovarian CancerStudies of the same condition, open and under way.
- More trials run by BeiGeneThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Principal investigator, BeiGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333915
- Sponsor's protocol ID
- BGB-290-102
- Other IDs
- CTR20160828
- Status last verified
- Jul 2023
- First submitted
- 1 Nov 2017
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Multi-Center Phase I/II Study to Evaluate Efficacy and Safety of BGB-290 in Chinese Subjects With Advanced Ovarian Cancer, Fallopian Cancer, and Primary Peritoneal Cancer or Advanced Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT03333915
- Acronym / sponsor ID
- BGB-290-102
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2016 (actual)
- Primary completion
- 24 Aug 2020 (actual)
- Study completion
- 11 Aug 2021 (actual)
- First posted
- 7 Nov 2017 (actual)
- Results
- Posted 22 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the safety, tolerability, PKharmacokinetic profile and treatment effect of pamiparib in Chinese participants with advanced high-grade ovarian cancer (including fallopian cancer or primary peritoneal cancer) and triple negative breast cancer in phase I, and to evaluate the efficacy and safety of pamiparib in Chinese participants with recurrent epithelial ovarian cancer (including fallopian cancer or primary peritoneal cancer), harboring germline breast cancer susceptibility gene 1/gene 2 (BRCA1/2) mutation in phase II.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Phase 1: 20 milligram (mg) pamiparib | Experimental | Drug: Pamiparib20 mg pamiparib twice a day for 21 days |
| Phase 1 : 40 mg pamiparib | Experimental | Drug: Pamiparib40 mg pamiparib twice a day for 21 days |
| 60 mg pamiparib | Experimental | Drug: Pamiparib60 mg pamiparib twice a day for 21 days |
| 60 mg pamiparib in platinum-sensitive ovarian cancer (PSOC) | Experimental | Drug: Pamiparib60 mg pamiparib twice a day until occurrence of unacceptable toxicities, disease progression, withdrawal of consent or investigator discretion |
| 60 mg pamiparib in platinum resistant ovarian cancer (PROC) | Experimental | Drug: Pamiparib60 mg pamiparib twice a day until occurrence of unacceptable toxicities, disease progression, withdrawal of consent or investigator discretion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants have voluntarily agreed to participate by giving written informed consent.
- Age 18 years (including 18 years) on the day of signing informed consent.
- Participants meet the following eligibility criteria for the corresponding part of the study: 1) In Phase 1 portion: The participants must have a histologically or cytologically confirmed locally advanced or metastatic cancer, either triple-negative breast cancer or epithelial, non-mucinous, high-grade ovarian cancer (including fallopian cancer, or primary peritoneal cancer), for which no effective standard therapy is available.
- 2) In Phase 2 portion: Participants who have histologically or cytologically confirmed high-grade epithelial ovarian cancer (including fallopian cancer or primary peritoneal cancer), harboring germline BRCA1/2 mutation 4. Participants must have measurable disease as defined per the RECIST, version 1.1.
- 5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
Key exclusion criteria (6 listed)
- Participants who have been treated with chemotherapy, biologic therapy, immunotherapy, investigational agent, anti-cancer Chinese medicine, or anticancer herbal remedies ≤ 14 days (or ≤5 half-lives, whichever is shorter) prior to starting study drug, or who have not adequately recovered from the side effects of such therapy.
- Participants who have undergone major surgery for any cause ≤ 4 weeks prior to starting study drug. Participants must have adequately recovered from the previous treatment and have a stable clinical condition before entering the study.
- Participants who have undergone radiotherapy for any cause ≤ 14 days prior to starting study drug. Participants must have adequately recovered from the previous treatment and have a stable clinical condition before entering the study.
- Untreated and/or active brain metastases.
- Prior therapies targeting poly (ADP-ribose) polymerase (PARP).
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 |
|---|---|---|
| PamiparibAlso: BGB-290Pamiparib is provided as oral capsules | Drug | 60 mg pamiparib, 60 mg pamiparib in platinum resistant ovarian cancer (PROC), 60 mg pamiparib in platinum-sensitive ovarian cancer (PSOC), Phase 1 : 40 mg pamiparib, Phase 1: 20 milligram (mg) pamiparib |
Primary outcome
Phase 1: Number of Participants With Treatment- Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
Time frame: From first dose to within 30 days of last dose of pamiparib (approximately 36 months)
A TEAE is defined as an adverse event (AE) that had an onset date on or after the first dose of study drug up to 30 days following study drug discontinuation or was worsening in severity from baseline (pretreatment).
Phase 1: Number of Participants With Clinically Significant Abnormalities in Physical Examinations and Electrocardiograms (ECGs)
Time frame: From first dose to within 30 days of last dose of pamiparib (approximately 36 months)
Phase 2: Objective Response Rate (ORR) in High Grade Ovarian Cancer (HGOC) Both PSOC and PROC as Assessed by Independent Radiology Review Committee (IRC)
Time frame: Up to approximately 2 years and 8 months
ORR is defined as the percentage of participants with confirmed Complete Response or Partial Response
23 secondary outcomes
Phase I: Maximum Observed Plasma Concentration (Cmax)
Time frame: Cycle 1 Day 1 and Day 10 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Phase I: Time to Reach Cmax (Tmax)
Time frame: Cycle 1 Day 1 and Day 10 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Phase I: Terminal Elimination Half-life (t1/2)
Time frame: Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Phase I: Apparent Clearance (CL/F)
Time frame: Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Phase 1: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf)
Time frame: Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Phase I: Apparent Volume of Distribution During Terminal Phase (Vz/F)
Time frame: Cycle 1 Day 1 of 21-day cycle: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Phase I: Confirmed Objective Response Rate (ORR) as Assessed by the Investigator Per RECIST v1.1
Time frame: Up to approximately 36 months
Phase 1: Disease Control Rate (DCR) Assessed by the Investigator Per RECIST v1.1
Time frame: Up to approximately 36 months
Phase I: Clinical Benefit Rate (CBR) Assessed by the Investigator Per RECIST v1.1
Time frame: Up to approximately 36 months
Phase 1: Duration of Response (DOR) as Assessed by Investigator Per RECIST v1.1
Time frame: Up to approximately 36 months
Phase I : Progression Free Survival (PFS)
Time frame: Up to approximately 36 months
Phase 2: Objective Response Rate (ORR) by Investigator Per RECIST v1.1
Time frame: Up to approximately 3 years and 8 months
Phase 2: Disease Control Rate by Investigator Per RECIST v1.1
Time frame: Up to approximately 3 years and 8 months
Phase 2: Clinical Benefit Rate by Investigator Per RECIST v1.1
Time frame: Up to approximately 3 years and 8 months
Phase 2: Carcinoma Antigen-125 (C(A-125) Response Rate by Gynecologic Cancer Inter Group (GCIG )Criteria
Time frame: Up to approximately 3 years and 8 months
Phase 2: Duration of Response as Assessed by Investigator Per RECIST v1.1
Time frame: Up to approximately 3 years and 8 months
Phase 2: Progression Free Survival as Assessed by the Investigator Per RECIST v1.1
Time frame: Up to approximately 3 years and 8 months
Phase 2: Overall Survival (OS) as Assessed by Investigator
Time frame: Up to approximately 3 years and 8 months
Phase 2: Number of Participants With Treatment- Emergent Adverse Events and Serious Adverse Events
Time frame: From first dose to within 30 days of last dose of pamiparib (approximately 3 years and 8 months)
Phase 2: Area Under the Plasma Concentration-time Curve From 0 to 12 Hours Post-dose (AUC0-12)
Time frame: Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Phase 2: Maximum Observed Plasma Concentration (Cmax)
Time frame: Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Phase 2: Time to Reach Cmax (Tmax)
Time frame: Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Phase 2: Area Under the Plasma Concentration-time Curve From 0 to the 9 Hours Post-dose (AUC0-9)
Time frame: Cycle 1 Day 1 and Cycle 2 Day 1: pre-dose, 0.5, 1, 2, 4, 6,9 and 12 hours post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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A Clinical Trial of Raludotatug Deruxtecan (R-DXd) With or Without Bevacizumab in Participants With Ovarian Cancer Who Have Progressed During Treatment With PARP-inhibitors Treatment on First Line Maintenance (MK-5909-008/ENGOT-ov107/GOG-3142 / REJOICE-Ovarian05)
Ovarian Cancer, Peritoneal Cancer
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.
Study Director principal investigator
BeiGene
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pamiparib in people with Advanced High-grade Ovarian Cancer and Triple Negative Breast Cancer, run by BeiGene at 6 sites 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 5 inclusion and 6 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 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 22 Feb 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?
Phase 1: Number of Participants With Treatment- Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE) (time frame: From first dose to within 30 days of last dose of pamiparib (approximately 36 months)). The study lists 3 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 4 Feb 2025.