Study Of The Effect Of CP-751,871 In Combination With Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer

Phase 3

Withdrawn

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: CP-751,871; Drug: Cisplatin; Drug: Gemcitabine

• Registration Number: NCT00907504
• Lead Sponsor: Pfizer

Brief Summary

Gemcitabine and cisplatin given together is a standard treatment option for advanced lung cancer patients. The purpose of this study is to assess if the life span is longer in patients taking the investigational drug CP-751,871 in combination with gemcitabine and cisplatin compared to gemcitabine and cisplatin alone. Considering a 10% rate of drop-outs, 1,210 participants will be required in order to have an adequate sample size (1,100 evaluable patients) and power to detect a 30% prolongation of survival on the experimental arm.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2009-05-20
• Study First Submitted QC: 2009-05-20
• Study First Posted: 2009-05-22
• Study Start: 2010-07
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-16
• Last Update Posted: 2014-06-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Non-Small Cell Lung Cancer (NSCLC), advanced, chemotherapy-naive
• Male or female > 18 years
• Eastern Oncology Cooperative Group (ECOG) Performance Status (PS) 0 or 1
• Adequate organ function

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Exclusion Criteria

• Uncontrolled hypertension or diabetes;
• Pregnant female;
• Symptomatic Central Nervous System (CNS) metastasis, requirement for chronic corticosteroids.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CP-751,871 + Gemcitabine + Cisplatin	CP-751,871	investigational arm
CP-751,871 + Gemcitabine + Cisplatin	Cisplatin	investigational arm
CP-751,871 + Gemcitabine + Cisplatin	Gemcitabine	investigational arm
Gemcitabine + Cisplatin	Cisplatin	standard of care
Gemcitabine + Cisplatin	Gemcitabine	standard of care

Primary Outcome Measures

Name	Time	Method
Overall Survival	Dec 2012

Secondary Outcome Measures

Name	Time	Method
Progression Free survival	Dec 2011
Objective Response	Dec 2011
Overall Safety Profile	Dec 2012
Patient Reported Outcome	Dec 2012
Pharmacokinetics	Dec 2012
Anti-drug Antibody	Dec 2012
Biomarker Analysis	Dec 2012