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OpenTrials
Completed

NCT Number: NCT00050830

A Phase 2, Randomized, Open-Label Study Of Single Agent CI-1033 In Patients With Advanced Non-Small Cell Lung Cancer

The purpose of study to determine the activity of CI 1033 against tumors in patients with advanced or metastatic NSCLC who have failed prior platinum-based combination chemotherapy. Another objective is to determine the safety of CI 1033.

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Key information

Conditions

Lung Neoplasms Lung Diseases Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically documented diagnosis of progressive or recurrent, locally advanced or metastatic NSCLC; a tumor that expresses at least one member of the erbB family of receptors; failed or relapsed after receiving a platinum-containing regimen as therapy; at least one measurable target lesion as defined by RECIST that has not been irradiated.

Exclusion criteria

  • Prior exposure to agents that target the erbB receptor family; unknown response to prior platinum-containing chemotherapy regimen; cytotoxic chemotherapy within 3 weeks prior to baseline disease assessments (6 weeks for nitrosoureas or mitomycin); more than 2 prior chemotherapy regimens: immunotherapy or other biologic therapy within 2 weeks prior to baseline disease assessment; prior irradiation to areas encompassing greater than 30% of marrow-bearing bone; brain metastases.

Treatment and study plan

CI 1033

Drug

Primary outcomes

  1. The primary objective is to assess the antitumor activity of CI 1033 in patients with advanced (progressive or recurrent, locally advanced [TNM Stage IIIB] or metastatic [TNM Stage IV]) NSCLC who have failed prior platinum-based combination chemotherapy

Secondary outcomes

  1. Secondary objectives also include determining the safety of CI 1033 and the detection of any correlations between baseline tumor erbB expression and efficacy. Safety will be assessed by spontaneous AE reporting, physical examinations

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Important dates

Study start
2003
Study completion
2005
First posted
Dec 24, 2002
Registry last updated
Nov 8, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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