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Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer

NCT00673049 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 583

Last updated 2013-07-24

Study results available
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Summary

The objective of this study is to test a clinical benefit of the addition of CP 751,871 to erlotinib therapy in patients with advanced NSCLC of non adenocarcinoma histology. The primary endpoint is Overall Survival (OS).

Conditions

  • Carcinoma, Large Cell
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell
  • Carcinoma, Adenosquamous Cell

Interventions

DRUG

CP 751,871 (Figitumumab)

CP 751,871 (20 mg/kg) will be administered as an IV infusion on study Days 1 and 2 in Cycle 1, and every three weeks (from Day 1) (Cycle) thereafter.

DRUG

Erlotinib

Erlotinib (one tablet of 150 mg/day PO).

DRUG

Erlotinib

Erlotinib (one tablet of 150 mg/day PO). Erlotinib will be taken at least one hour before or two hours after the ingestion of food.

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
2008-05-31
Primary Completion
2011-03-31
Completion
2012-04-30

Countries

  • United States
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Chile
  • Czechia
  • France
  • Greece
  • Hungary
  • Indonesia
  • Ireland
  • Italy
  • Latvia
  • Poland
  • Puerto Rico
  • Romania
  • Russia
  • Serbia
  • Slovenia
  • South Africa
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT00673049 on ClinicalTrials.gov