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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT01349660
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Glioblastoma Multiforme

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Bevacizumab 10 mg/kg IV every 2 weeks
  • BKM120 — DRUG
    BKM120 orally (PO) once daily

Study Details

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.

Key Dates

First listed
May 6, 2011
Start date
Dec 31, 2011
Status verified
Jun 2020
Primary completion
Dec 31, 2016
Completion
Dec 29, 2018

Study Design

Enrollment
88 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BKM120/Bevacizumab
    Phase I: BKM 120 orally (PO) once daily (dose is 60mg or 80mg). Bevacizumab: 10mg/kg intravenous (IV) every 2 weeks Phase II: BKM 120 orally (PO) once daily - dose is optimal dose determined in Phase I. Bevacizumab: 10mg/kg intravenous (IV) every 2 weeks

Primary Outcome Measure

Number of Phase I Patients Receiving 60mg or 80mg BKM120 Experiencing a Dose-Limiting Toxicity (DLT) to Determine the Optimal Dosage [ Time Frame: Collected from day of first dose to the end of the first treatment cycle, up to 28 days ]

Locations (8)

FacilityCityStateZIPSite coordinators
Yale School of MedicineNew HavenConnecticut06520-
Florida Cancer SpecialistsFort MyersFlorida33916-
Florida Hospital Cancer InstituteOrlandoFlorida32804-
Florida Cancer SpecialistsSt. PetersburgFlorida33705-
Center for Cancer and Blood DisordersBethesdaMaryland20817-
Grand Rapids Oncology ProgramGrand RapidsMichigan49503-
Nebraska Methodist HospitalOmahaNebraska68114-
Tennessee OncologyNashvilleTennessee37203-

Find similar trials in New Haven, CT

By research site
Yale School of Medicine· New Haven, CTFlorida Cancer Specialists· Fort Myers, FLFlorida Hospital Cancer Institute· Orlando, FLFlorida Cancer Specialists· St. Petersburg, FLCenter for Cancer and Blood Disorders· Bethesda, MDGrand Rapids Oncology Program· Grand Rapids, MI

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