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MONET1-MOtesanib NSCLC Efficacy and Tolerability Study

NCT00460317 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1450

Last updated 2015-09-07

No results posted yet for this study

Summary

To determine if treatment with AMG 706 (motesanib diphosphate) in combination with paclitaxel and carboplatin improves overall survival compared to treatment with placebo in combination with paclitaxel and carboplatin in subjects with advanced non-squamous NSCLC and in subjects with adenocarcinoma histology (adenocarcinoma subpopulation).

Conditions

Interventions

DRUG

AMG 706

125 mg QD orally every day

DRUG

placebo

125 mg QD orally every day

DRUG

paclitaxel

200mg/m2 on day 1 of each 3 week cycle +/- 3 days for a max of 6 cycles

DRUG

carboplatin

AUC of 600mg/mL x min by Calvert formula on day 1 of each 3 week cycle +/- 3 days for a max of 6 cycles

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2011-03-31
Completion
2013-08-31

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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 NCT00460317 on ClinicalTrials.gov