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Combination of BKM120 and Bevacizumab in Refractory Solid Tumors and Relapsed/Refractory Glioblastoma Multiforme
NCT01349660 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SCRI Development Innovations, which has 63 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01349660 reports 8 study locations spanning 6 distinct geographic areas — top geographies include Florida, Connecticut, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01349660?
The interventions under investigation include: Bevacizumab (DRUG), BKM120 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01349660?
This trial is sponsored by SCRI Development Innovations, which has 63 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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