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BEP Study Phase I (Bevacizumab, Everolimus, Panitumumab)

NCT00586443 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2014-11-19

No results posted yet for this study

Summary

Targeting molecular pathways of tumor growth has become a major focus of anti-cancer treatments. This study aims to investigate the toxicity, pharmacokinetics, and preliminary efficacy of the triplet combination of bevacizumab, RAD001, and panitumumab in patients with refractory solid tumors.

This open-labeled, non-randomized phase I trial of bevacizumab, everolimus and panitumumab is designed to assess the safety, tolerability and efficacy of this combination in adult patients with advanced solid tumors.

Conditions

Interventions

DRUG

bevacizumab, everolimus, panitumumab

Cohort # subjects Bevacizumab Everolimus Panitumumab * 3 3-6 5 mg/kg IV Q2 weeks 5 mg PO QoD 3.6 mg/kg IV Q2 weeks * 2 3-6 5 mg/kg IV Q2 weeks 5 mg PO QoD 4.8 mg/kg IV Q2 weeks * 1 3-6 10 mg/kg IV Q2 weeks 5 mg PO QD 4.8 mg/kg IV Q2 weeks 1. 3-6 10 mg/kg IV Q2 weeks 10 mg PO QD 4.8 mg/kg IV Q2 weeks 2. 3-6 10 mg/kg IV Q2 weeks 10 mg PO QD 6 mg/kg IV Q2 weeks 3a 10 RPTD\* RPTD\* RPTD\* 3b 10 RPTD\*\* RPTD\*\* RPTD\*\* * Panitumumab and RAD001 started on Day 1, bevacizumab started on Day 15. \*\*Bevacizumab and RAD001 started on Day 1, panitumumab started on Day 15.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Genentech, Inc.

    collaborator INDUSTRY

  • Amgen

    collaborator INDUSTRY

  • Herbert Hurwitz, MD

    lead OTHER

Principal Investigators

  • Herbert I Hurwitz, MD · Duke University

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2014-09-30
Completion
2014-09-30

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 NCT00586443 on ClinicalTrials.gov