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A Phase 2 Trial of AMG 706 or Bevacizumab in Combination With Chemo for Advanced NSCLC

NCT00369070 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2018-01-04

No results posted yet for this study

Summary

The purpose of this study is to estimate the difference in objective response rates between each paclitaxel/carboplatin plus AMG 706 arm (Arm A and B) and paclitaxel/carboplatin plus bevacizumab arm (Arm C) in subjects with advanced non-squamous NSCLC.

Conditions

  • Advanced Non-squamous NSCLC

Interventions

BIOLOGICAL

Bevacizumab

15 mg/kg bevacizumab, delivered via intravenous (IV) infusion once every 3 weeks

DRUG

AMG 706

subjects in Arms A and B will take AMG 706 orally in one of two dosing regimens over each 21-day cycle: •Arm A: 125 mg once daily (QD) •Arm B: 75 mg twice daily every 12 ± approximately 1 hour for 5 days followed by a 2 day treatment free period every 7 days

DRUG

Paclitaxel

All subjects will receive a paclitaxel chemotherapy regimen (paclitaxel 200 mg/m2) on day 1 of each 3-week cycle for a maximum of 6 cycles.

DRUG

Carboplatin

All subjects will receive carboplatin chemotherapy regimen (carboplatin at AUC of 6 mg/mL x min) on day 1 of each 3-week cycle for a maximum of 6 cycles.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-04-23
Completion
2011-08-03

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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 NCT00369070 on ClinicalTrials.gov