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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
BBI503 will be administered orally, once daily. Dosing will begin at 200 mg once daily, preferably at bedtime and 2 hours after a meal. Dose modification in case of adverse events is allowed according to the schedule below; Full dose: 200 mg daily, Modification Level-1: 100 mg daily, Modification Level-2: 50 mg daily.
Mayo Clinic
Rochester, Minnesota, United States
Disease Control Rate (DCR)
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).
Time frame: From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 24 weeks
Progression Free Survival (PFS)
The effect of amcasertib (BBI503) on PFS in asymptomatic recurrent ovarian cancer patients with CA-125 elevation
Time frame: 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
Progression Free Survival (PFS)-6
The effect of amcasertib (BBI503) on PFS at 6 months in asymptomatic recurrent ovarian cancer patients with CA-125 elevation
Time frame: 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
Objective Response Rate (ORR)
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).
Time frame: From the date of first treatment, every 8 weeks, until the date of first documented objective disease progression, up to 18 months
Overall Survival (OS) at 6 Months
Defined as the time from enrollment to death due to any cause.
Time frame: 4 weeks after the patient has been off study treatment, every 3 months thereafter until death, up to 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Number of Patients With Adverse Events
Assessment of safety of amcasertib in participants by reporting of adverse events and serious adverse events
Time frame: 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.