A Study of BBI503 in Asymptomatic Recurrent Ovarian Cancer Patients With CA-125 Elevation
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|ClinicalTrials.gov Identifier: NCT02432690|
Recruitment Status : Completed
First Posted : May 4, 2015
Last Update Posted : April 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cancer Ovarian Cancer||Drug: BBI503||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Clinical Study of BBI503 in Asymptomatic Recurrent Ovarian Cancer Patients With CA-125 Elevation|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||January 3, 2017|
|Actual Study Completion Date :||July 2, 2017|
|Experimental: Arm A||
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.
- Disease Control Rate (DCR) [ Time Frame: 8 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).
- Progression Free Survival (PFS) [ Time Frame: 24 months ]Defined as the time from enrollment to the first objective documentation of disease progression or death due to any cause.
- Progression Free Survival (PFS)-6 [ Time Frame: 6 months ]Defined as the proportion of patients with progression free survival (PFS) i.e. absence of documented objective progression or death at 6 months after enrollment
- Objective Response Rate (ORR) [ Time Frame: 8 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).
- Overall Survival (OS) [ Time Frame: 24 months ]Defined as the time from enrollment to death due to any cause.
- Number of Patients with Adverse Events [ Time Frame: 24 months ]The incidence of adverse events will be summarized by type of adverse event and severity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02432690
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|