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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ClinicalTrials.gov Identifier: NCT00050830 |
Recruitment Status :
Completed
First Posted : December 24, 2002
Last Update Posted : November 8, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lung Neoplasms | Drug: CI 1033 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 163 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2, Randomized, Open-Label Study Of Single Agent CI-1033 In Patients With Advanced Non-Small Cell Lung Cancer |
Study Start Date : | January 2003 |
Study Completion Date : | November 2005 |

- 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 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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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00050830

Study Director: | Pfizer CT.gov Call Center | Pfizer |
ClinicalTrials.gov Identifier: | NCT00050830 |
Other Study ID Numbers: |
A4161003 |
First Posted: | December 24, 2002 Key Record Dates |
Last Update Posted: | November 8, 2006 |
Last Verified: | January 2006 |
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