Study Complete
Sponsor ID
20040153

Study to Evaluate Motesanib with or without Carboplatin/Paclitaxel or Panitumumab in the Treatment of Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)

Sponsor ID
20040153
Clinicaltrials.gov ID
NCT00094835
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The purpose of this trial is: - To characterize the safety profile of motesanib when used in combination with carboplatin/paclitaxel (CP), with panitumumab or with CP and panitumumab in patients with advanced non-small cell lung cancer (NSCLC). - To establish the pharmacokinetic (PK) profile of motesanib when it is used in combination with CP, with panitumumab, or with CP and panitumumab. - To compare the paclitaxel and motesanib PK profiles when the medications are administered 30 minutes (min) or approximately 48 hours (hrs) apart. - To characterize the panitumumab and paclitaxel exposure in the combination regimens of motesanib with CP, motesanib with panitumumab, or motesanib with CP and panitumumab. - To describe the objective response rate (ORR) in each dose cohort. - To measure the immunogenicity of panitumumab in patients administered motesanib with panitumumab and motesanib with CP and panitumumab.

Additional Study Details

Phase
Phase 1/Phase 2
Product
motesanib diphosphate
Type
Interventional
Masking
None (Open Label)
Enrollment
51
Additional Study Details

Protocol Summary

Primary Outcome Measures

tmax for Cycle 1

Timeframe: Overall Study

Cmax for Cycle 1

Timeframe: Overall Study

t1/2,z in Cycle 1

Timeframe: Overall Study

AUC in Cycle 1

Timeframe: Overall Study

C24 in Cycle 1

Timeframe: Overall Study

tmax for Cycle 2

Timeframe: Overall Study

Cmax in Cycle 2

Timeframe: Overall Study

t1/2,z in Cycle 2

Timeframe: Overall Study

AUC in Cycle 2

Timeframe: Overall Study

C24 in Cycle 2

Timeframe: Overall Study

Secondary Outcome Measures

Objective response rate (ORR)

Timeframe: Overall Study

Study Documents

Study Synopsis
Available Language(s): English

Locations

No locations found.