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

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03419884
• Other study ID #: BGB-290-302
• Status: Not yet recruiting
• Phase: Phase 3
• First received: January 29, 2018
• Last updated: February 1, 2018
• Start date: March 31, 2018
• Est. completion date: February 28, 2021

Study information

• Verified date: January 2018
• Source: BeiGene
• Contact: Miao Li, Medical Director
• Phone: 861058958000
• Email: clinicaltrials[@]beigene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy, safety tolerability of maintenance therapy with BGB-290 versus placebo in Chinese patients with recurrent ovarian cancer who achieved a complete response (CR) or partial response (PR) after platinum-based chemotherapy

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 216
• Est. completion date: February 28, 2021
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 BGB-290 capsule

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• BGB-290 capsule
60 mg BID, PO
• Placebo capsule
60mg BID, PO

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		Up to 2 years
Secondary	Overall survival		Up to 3 years
Secondary	Objective response rate		Up to 2 years
Secondary	Duration of response		Up to 2 years