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

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BeiGene

Status and phase

Active, not recruiting
Phase 3

Conditions

Ovarian Cancer

Treatments

Drug: Pamiparib capsule
Drug: Placebo capsule

Study type

Interventional

Funder types

Industry

Identifiers

NCT03519230
CTR20171666 (Registry Identifier)
BGB-290-302
ChiCTR1800014643 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment

224 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

224 participants in 2 patient groups, including a placebo group

Treatment arm
Experimental group
Treatment:
Drug: Pamiparib capsule
Placebo arm
Placebo Comparator group
Treatment:
Drug: Placebo capsule

Trial contacts and locations

28

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Data sourced from clinicaltrials.gov

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