Maintenance Treatment With BGB-290 Versus Placebo in Participants With Platinum-sensitive Recurrent Ovarian Cancer
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| ClinicalTrials.gov Identifier: NCT03519230 |
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Recruitment Status :
Active, not recruiting
First Posted : May 8, 2018
Last Update Posted : June 23, 2021
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Sponsor:
BeiGene
Information provided by (Responsible Party):
BeiGene
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Brief Summary:
To evaluate the efficacy, safety and tolerability of maintenance therapy with BGB-290(Pamiparib) versus placebo in Chinese participants with recurrent ovarian cancer who achieved a complete response (CR) or partial response (PR) after platinum-based chemotherapy
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ovarian Cancer | Drug: Pamiparib capsule Drug: Placebo capsule | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 216 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Trial of Maintenance Treatment With BGB-290 Versus Placebo in Patients With Platinum-sensitive Recurrent Ovarian Cancer |
| Actual Study Start Date : | May 14, 2018 |
| Estimated Primary Completion Date : | June 30, 2022 |
| Estimated Study Completion Date : | June 30, 2026 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Ovarian cancer
MedlinePlus related topics:
Ovarian Cancer
| Arm | Intervention/treatment |
|---|---|
| Experimental: Treatment arm |
Drug: Pamiparib capsule
60 mg twice daily (BID), orally (per os-PO)
Other Name: BGB-290 |
| Placebo Comparator: Placebo arm |
Drug: Placebo capsule
60mg BID, PO |
Primary Outcome Measures :
- Progression free survival [ Time Frame: Up to 2 years ]
Secondary Outcome Measures :
- Overall survival [ Time Frame: up to 3 years ]
- Objective response rate [ Time Frame: up to 2 years ]
- Duration of response [ Time Frame: up to 2 years ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Histologically diagnosed high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer)
- Completion of ≥2 previous platinum-containing regimens (eg, carboplatin or cisplatin)
- Complete response (CR) or partial response (PR) achieved with last platinum-based chemotherapy regimen as determined by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- Ability to be randomized ≤8 weeks after last dose of platinum
Key Exclusion Criteria:
- Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor
- Progressive disease (PD) as per CA-125 criteria before randomization
- Diagnosis of myelodysplastic syndrome (MDS)
- Known history of intolerance to the excipients of the Pamiparib capsule
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519230
Locations
Show 28 study locations
Sponsors and Collaborators
BeiGene
Investigators
| Principal Investigator: | Ding Ma, PhD | Tongji Hospital |
| Responsible Party: | BeiGene |
| ClinicalTrials.gov Identifier: | NCT03519230 |
| Other Study ID Numbers: |
BGB-290-302 ChiCTR1800014643 ( Registry Identifier: Chinese Clinical Trial Registry ) CTR20171666 ( Registry Identifier: Center for drug evaluation, CFDA ) |
| First Posted: | May 8, 2018 Key Record Dates |
| Last Update Posted: | June 23, 2021 |
| Last Verified: | June 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |