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

NCT01055795 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2012-12-24

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

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

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Genentech, Inc.

    collaborator INDUSTRY

  • Herbert Hurwitz

    lead OTHER

Principal Investigators

  • Herbert I Hurwitz, Md · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-08-31
Completion
2012-05-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01055795 on ClinicalTrials.gov