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Maintenance Treatment With BGB-290 Versus Placebo in Participants With Platinum-sensitive Recurrent Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03519230
Recruitment Status : Active, not recruiting
First Posted : May 8, 2018
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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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 Design
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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 : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Progression free survival [ Time Frame: Up to 2 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: up to 3 years ]
  2. Objective response rate [ Time Frame: up to 2 years ]
  3. Duration of response [ Time Frame: up to 2 years ]

Eligibility Criteria
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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:

  1. Histologically diagnosed high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer)
  2. Completion of ≥2 previous platinum-containing regimens (eg, carboplatin or cisplatin)
  3. 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
  4. Ability to be randomized ≤8 weeks after last dose of platinum

Key Exclusion Criteria:

  1. Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor
  2. Progressive disease (PD) as per CA-125 criteria before randomization
  3. Diagnosis of myelodysplastic syndrome (MDS)
  4. Known history of intolerance to the excipients of the Pamiparib capsule

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Contacts and Locations
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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
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Sponsors and Collaborators
BeiGene
Investigators
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Principal Investigator: Ding Ma, PhD Tongji Hospital
More Information
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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 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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