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

NCT00907504 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2014-06-17

No results posted yet for this study

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.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

CP-751,871

CP-751,871 20mg/kg every 3 weeks

DRUG

Cisplatin

Cisplatin 80 mg/m2 every 3 weeks

DRUG

Gemcitabine

Gemcitabine 1,250 mg/m2 Day1+8 of evey 3 week-cycle

DRUG

Cisplatin

Cisplatin 80 mg/m2 every 3 weeks

DRUG

Gemcitabine

Gemcitabine 1,250 mg/m2 Day1+8 of evey 3 week-cycle

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2014-05-31
Completion
2014-05-31

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Entities

Drugs
Companies

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 NCT00907504 on ClinicalTrials.gov