Terminated/Withdrawn
Sponsor ID
20060136

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

Sponsor ID
20060136
Clinicaltrials.gov ID
NCT00369070
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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.

Additional Study Details

Phase
Phase 2
Product
motesanib diphosphate
Type
Interventional
Masking
None (Open Label)
Enrollment
186
Additional Study Details

Protocol Summary

Primary Outcome Measures

Objective tumor response rate

Timeframe: Response assessments will be obtained every 6 +/- 1 week until subjects develop disease progression.

Secondary Outcome Measures

Duration of response

Timeframe: Time from first objective tumor response to disease progression or death, if the death was due to disease progression.

Progression free survival

Timeframe: Number of days from randomization tot he date of radiological evidence of disease progression or death.

Overall survival

Timeframe: Time from randomization to death.

Pharmacokinetics of AMG 706 when administered with paclitaxel and carboplatin in Arms A and B

Timeframe: From randomization until disease progression or death.

Safety and tolerability in the 3 arms

Timeframe: From randomization until disease progression or death.

Study Documents

Study Synopsis
Available Language(s): English

Locations

No locations found.