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Randomized, Open Label, Phase 3 Clinical Study To Evaluate The Effect Of The Addition Of CP-751,871 To Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small-Cell Lung

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Trial Information

Randomized, Open Label, Phase 3 Clinical Study To Evaluate The Effect Of The Addition Of CP-751,871 To Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer


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

Exclusion Criteria:

- Uncontrolled hypertension or diabetes;

- Pregnant female;

- Symptomatic Central Nervous System (CNS) metastasis, requirement for chronic
corticosteroids.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

Dec 2012

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A4021017

NCT ID:

NCT00907504

Start Date:

July 2010

Completion Date:

May 2014

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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