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

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ClinicalTrials.gov Identifier: NCT03519230
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : July 19, 2019
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 patients 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 : April 25, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : February 28, 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 BID, PO
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

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

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
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


Contacts
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Contact: Liping Ma +861058958000 clinicaltrials@beigene.com

  Show 28 Study Locations
Sponsors and Collaborators
BeiGene
Investigators
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Principal Investigator: Ding Ma Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
More Information
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Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT03519230     History of Changes
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: July 19, 2019
Last Verified: May 2019

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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 Diseases, Female
 Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type