BEP Study Phase I (Bevacizumab, Everolimus, Panitumumab)

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Herbert Hurwitz, MD
Study ID
NCT00586443
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumors

Eligibility Criteria

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

Interventions

  • bevacizumab, everolimus, panitumumab — DRUG
    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.

Study Details

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.

Key Dates

First listed
Jan 4, 2008
Start date
Nov 30, 2007
Status verified
Nov 2014
Primary completion
Sep 30, 2014
Completion
Sep 30, 2014

Study Design

Enrollment
56 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP

Arms

  • Other: I
    This is a Phase I safety study. There is only one arm.

Primary Outcome Measure

To determine the MTD/recommended phase II regimen and evaluate safety of panitumumab added to RAD001 plus bevacizumab in adult patients with advanced solid tumors. [ Time Frame: Every cycle (28-days) ]

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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