Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-Free Survival (PFS)

Outcome Description:

Median time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS time (days) = [event (progression or death) date or censor date - date of randomization + 1].

Outcome Time Frame:

Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression

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:

A4021032

NCT ID:

NCT00977561

Start Date:

April 2010

Completion Date:

October 2011

Related Keywords:

• Small Cell Lung Carcinoma
• Small Cell Lung Cancer
• Extensive stage disease
• SCLC
• IGF-1R inhibitor
• Carcinoma
• Lung Neoplasms
• Small Cell Lung Carcinoma