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.
Information provided by:
First received: December 20, 2002
Last updated: November 6, 2006
Last verified: January 2006
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.
Drug: CI 1033
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase 2, Randomized, Open-Label Study Of Single Agent CI-1033 In Patients With Advanced Non-Small Cell Lung Cancer
Primary Outcome Measures:
- 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 Outcome Measures:
- 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
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00050830
||Pfizer CT.gov Call Center
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 20, 2002
||November 6, 2006
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 02, 2015
Carcinoma, Non-Small-Cell Lung
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents