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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00050830 |
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Date of registration:
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20/12/2002 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 |
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Date of first enrolment:
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January 2003 |
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Target sample size:
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163 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00050830 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Germany
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Ireland
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Italy
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Netherlands
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Spain
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United Kingdom
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United States
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lung Neoplasms
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Intervention(s)
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Drug: CI 1033
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Primary Outcome(s)
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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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Secondary Outcome(s)
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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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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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