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Clinical trialNCT01349660CompletedPhase 1/PHASE2Interventional

Combination of BKM120 and Bevacizumab in Refractory Solid Tumors and Relapsed/Refractory Glioblastoma Multiforme

SponsorSCRI Development Innovations, LLCEnrollment88Glioblastoma Multiforme
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

8 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Yale School of Medicine

    New Haven, Connecticut, United States

  • Florida Cancer Specialists

    Fort Myers, Florida, United States

  • Florida Hospital Cancer Institute

    Orlando, Florida, United States

  • Florida Cancer Specialists

    St. Petersburg, Florida, United States

  • Center for Cancer and Blood Disorders

    Bethesda, Maryland, United States

  • Grand Rapids Oncology Program

    Grand Rapids, Michigan, United States

  • Nebraska Methodist Hospital

    Omaha, Nebraska, United States

  • Tennessee Oncology

    Nashville, Tennessee, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Dec 2011
Primary completion
31 Dec 2016
Completion
29 Dec 2018
Last update posted
17 Jun 2020
Registered enrollment
88
Registry id
NCT01349660

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.