Trials / Terminated
TerminatedNCT02432690
A Study of BBI503 in Asymptomatic Recurrent Ovarian Cancer Patients With CA-125 Elevation
A Phase II Clinical Study of BBI503 in Asymptomatic Recurrent Ovarian Cancer Patients With CA-125 Elevation
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Sumitomo Pharma America, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BBI503 | 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. |
Timeline
- Start date
- 2015-06-01
- Primary completion
- 2017-01-02
- Completion
- 2017-01-02
- First posted
- 2015-05-04
- Last updated
- 2023-11-15
- Results posted
- 2022-08-29
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02432690. Inclusion in this directory is not an endorsement.