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NCT Number: NCT03519230

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital, Hefei, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pamiparib capsule

Drug

60 mg twice daily (BID), orally (per os-PO)

Other names: BGB-290

Placebo capsule

Drug

60mg BID, PO

Primary outcomes

  1. Progression free survival (PFS) by blinded Independent Review Committee (BIRC) assessment

    Time frame: up to 8 years

Secondary outcomes

  1. Overall survival

    Time frame: up to 9 years

  2. Objective response rate by investigator assessment

    Time frame: up to 2 years

  3. Duration of response by investigator assessment

    Time frame: up to 2 years

  4. PFS by investigator assessment

    Time frame: up to 8 years

  5. Time to response by investigator assessment

    Time frame: up to 8 years

  6. Number of participants with treatment-emergent adverse events (TEAEs)

    Time frame: up to 9 years

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2025
Study completion
2027
First posted
May 8, 2018
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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