A Study of BBI503 in Asymptomatic Recurrent Ovarian Cancer Patients With CA-125 Elevation

Phase 2

Terminated

• Conditions: Cancer; Ovarian Cancer
• Interventions: Drug: BBI503

• Registration Number: NCT02432690
• Lead Sponsor: Sumitomo Pharma America, Inc.

Brief Summary

This was an open-label, single-arm, Phase II study in which amcasertib (BBI503) was administered to adult, asymptomatic patients with recurrent ovarian cancer who had elevated CA-125.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-29
• Study First Submitted QC: 2015-05-01
• Study First Posted: 2015-05-04
• Study Start: 2015-06
• Primary Completion: 2017-01-02
• Study Completion: 2017-01-02
• Results First Submitted: 2022-07-07
• Results First Submitted QC: 2022-08-03
• Results First Posted: 2022-08-29
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm A	BBI503	-

Primary Outcome Measures

Name	Time	Method
Disease Control Rate (DCR)	From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 24 weeks	Assessed by the Gynecologic Cancer Intergroup (GCIG) guidelines which incorporate both CA-125 response and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (the latter applies to patients who have measurable disease). DCR was defined as the proportion of patients who had an overall response of complete response (CR), partial response (PR), or stable disease (SD).

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)-6	The time from the date of first treatment to the date of first documentation of disease progression or death due to any cause at 6 months	The effect of amcasertib (BBI503) on PFS at 6 months in asymptomatic recurrent ovarian cancer patients with CA-125 elevation
Progression Free Survival (PFS)	The time from the date of first treatment to the date of first documentation of disease progression or death due to any cause, up to 18 months	The effect of amcasertib (BBI503) on PFS in asymptomatic recurrent ovarian cancer patients with CA-125 elevation
Objective Response Rate (ORR)	From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 18 months	Assessed by the Gynecologic Cancer Intergroup (GCIG) guidelines which incorporate both CA-125 response and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (the latter applies to patients who have measurable disease).
Overall Survival (OS) at 6 Months	4 weeks after the patient has been off study treatment, every 3 months thereafter until death, up to 6 months	Defined as the time from enrollment to death due to any cause.
Number of Patients With Adverse Events	The time from the date of first treatment, while the patient is taking amcasertib, and for 30 days after stopping therapy, an average of 4 months.	Assessment of safety of amcasertib in participants by reporting of adverse events and serious adverse events

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States