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NCT01349660 · ClinicalTrials.gov registry record · Phase 1
Combination of BKM120 and Bevacizumab in Refractory Solid Tumors and Relapsed/Refractory Glioblastoma Multiforme
A Phase 1 study of Glioblastoma Multiforme, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 1
- Development phase
- 88
- Enrollment target
- 8
- Study locations
NCT01349660 is a Phase 1 study of Glioblastoma Multiforme that has completed, run by SCRI Development Innovations. The registered enrollment target is 88 participants, roughly in line with the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target. The trial reports 8 study locations across 6 states.
The verdict
NCT01349660, a Phase 1 study of Glioblastoma Multiforme, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 88 participants
- Enrollment target
- 8
- Study locations
Study Summary
In this phase I/II study,investigators are evaluating the feasibility and efficacy of the combination of BKM120, an oral inhibitor of PI3 kinase, and bevacizumab in the treatment of patients with relapsed/refractory GBM. In the Phase I part of the trial, the optimal BKM120 dose to be administered with a standard dose of bevacizumab will be determined in patients with refractory solid tumors. Although it is unlikely that the concurrent administration of bevacizumab will alter the pharmacokinetics of BKM120, limited pharmacokinetic sampling will be performed on all patients treated during the Phase II portion of the study. Assuming this combination is feasible, the Phase II portion of the study will proceed, using the doses determined in the Phase I portion. In the phase II portion, eligible patients will be limited to those with recurrent/progressive GBM following 1st line combined modality therapy.
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG BKM120
Study Locations (8)
Florida
- Florida Cancer Specialists - Fort Myers
- Florida Hospital Cancer Institute - Orlando
- Florida Cancer Specialists - St. Petersburg
Connecticut
- Yale School of Medicine - New Haven
Maryland
- Center for Cancer and Blood Disorders - Bethesda
Michigan
- Grand Rapids Oncology Program - Grand Rapids
Nebraska
- Nebraska Methodist Hospital - Omaha
Tennessee
- Tennessee Oncology - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2011-12 |
| Est. Completion | 2018-12-29 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01349660
The ClinicalTrials.gov registry entry for NCT01349660 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target. The listed sponsor is SCRI Development Innovations, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 2 interventions - of which Bevacizumab is the first listed.
NCT01349660 reports 8 study locations spanning 6 distinct geographic areas - top geographies include Florida, Connecticut, Maryland.
Frequently Asked Questions
What is clinical trial NCT01349660 about?
NCT01349660 is a clinical study titled "Combination of BKM120 and Bevacizumab in Refractory Solid Tumors and Relapsed/Refractory Glioblastoma Multiforme". In this phase I/II study,investigators are evaluating the feasibility and efficacy of the combination of BKM120, an oral inhibitor of PI3 kinase, and bevacizumab in the treatment of patients with relapsed/refractory GBM. In the Phase I part of the trial, the optimal BKM120 dose to be administered wi...
What is the current status of trial NCT01349660?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 88 participants. The study started on 2011-12. Estimated completion is 2018-12-29.
What conditions does trial NCT01349660 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme.
What interventions are being tested in trial NCT01349660?
The interventions under investigation include: Bevacizumab (DRUG), BKM120 (DRUG).
Who is sponsoring clinical trial NCT01349660?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01349660 being conducted?
This trial has 8 study locations across Connecticut, Florida, Maryland, Michigan, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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