Bevacizumab in Multiple Phase I Combinations

NCT00543504 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 343

Last updated 2020-06-30

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest tolerable dose of Avastin™ that can be given in combination with 4 other study drug/drug combinations. It will be given with sunitinib, with sorafenib, with a combination of erlotinib and cetuximab, and with a combination of trastuzumab and lapatinib. The safety and effectiveness of these drug combinations will also be studied.

Conditions

Interventions

DRUG

Bevacizumab

2.5 mg/kg By Vein Over 90 Minutes.

DRUG

Sorafenib

200 mg By Mouth Daily for 28 Days

DRUG

Erlotinib

50 mg By Mouth Daily for 28 Days.

DRUG

Trastuzumab

Loading 2 mg/kg by vein then Maintenance 1 mg/kg by vein on Day 1

DRUG

Lapatinib

250 mg By Mouth Daily for 21 Days.

DRUG

Sunitinib

12.5 mg orally daily for 4 weeks, then 2 weeks off.

DRUG

Cetuximab

Loading 100 mg/m² by vein and Maintenance 75 mg/m² by vein on Days 1, 8, 15, 22

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Funda Meric-Bernstam, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-10
Primary Completion
2020-04-29
Completion
2020-04-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT00543504 on ClinicalTrials.gov