Safety Study of Bevacizumab, Everolimus and LBH589 (BEL) for Advanced Solid Tumors

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Herbert Hurwitz
Study ID
NCT01055795
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab, Everolimus and LBH589 — DRUG
    Dose Escalation Cohort #, Subjects, Bevacizumab, Everolimus, LBH589 1. 3-6, All study drugs administered per dose level 2. 3-6, All study drugs administered per dose level 3. 3-6, All study drugs administered per dose level Expanded Cohorts Cohort #, Subjects, Bevacizumab, Everolimus, LBH589 A, B \& C; 30, Recommended Phase II Dose for all three compounds

Study Details

The main purpose of this study is to test the safety of three study drugs, bevacizumab (Avastin™), Everolimus (Afinitor™) and LBH589 (Panobinostat) when they are given together. It is hoped this study drug combination might lead to a greater decrease the in size of the cancer and/or slow down how fast the cancer is growing compared to when these drugs are given alone. Subjects will be enrolled at Duke University Medical Center (DUMC).

Key Dates

First listed
Jan 26, 2010
Start date
Mar 31, 2010
Status verified
Dec 2012
Primary completion
Aug 31, 2011
Completion
May 31, 2012

Study Design

Enrollment
14 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab, Everolimus and LBH589
    Dose Escalation Cohort #, Subjects, Bevacizumab, Everolimus, LBH589 1. 3-6, All study drugs administered per dose level 2. 3-6, All study drugs administered per dose level 3. 3-6, All study drugs administered per dose level Expanded Cohorts Cohort #, Subjects, Bevacizumab, Everolimus, LBH589 A, B \& C; 30, Recommended Phase II Dose for all three compounds

Primary Outcome Measure

To define the maximal tolerated dose (if any) and the recommended phase II dose for the triplet combination of everolimus plus LBH589 plus bevacizumab in subjects with advanced solid tumors [ Time Frame: 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University Medical CenterDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By research site
Duke University Medical Center· Durham, NC

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