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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00050830
First received: December 20, 2002
Last updated: November 6, 2006
Last verified: January 2006

December 20, 2002
November 6, 2006
January 2003
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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
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Complete list of historical versions of study NCT00050830 on ClinicalTrials.gov Archive Site
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
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A Phase 2, Randomized, Open-Label Study Of Single Agent CI-1033 In Patients With Advanced Non-Small Cell Lung Cancer
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Neoplasms
Drug: CI 1033
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
163
November 2005
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Germany,   Ireland,   Italy,   Netherlands,   Spain,   United Kingdom
 
NCT00050830
A4161003
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Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP