PH 1 Evaluation Of Oral CI-1033 In Combination With Paclitaxel/ Carboplatin As 1st Line Chemotherapy In NSCLC Patients
A Phase 1 Evaluation Of Oral CI-1033 In Combination With Paclitaxel And Carboplatin As First-Line Chemotherapy In Patients With Advanced Non-Small Cell Lung Cancer
1 other identifier
interventional
39
2 countries
7
Brief Summary
The main purpose of this study is to evaluate the overall safety and maximum dose of CI 1033 in combination with paclitaxel and carboplatin in patients with NSCLC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2002
Typical duration for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedNovember 8, 2006
January 1, 2006
September 9, 2005
November 6, 2006
Conditions
Outcome Measures
Primary Outcomes (1)
The primary objective is to evaluate the overall safety profile, including dose-limiting toxicities and the maximum tolerated dose, of CI 1033 in combination with paclitaxel (225 mg/m2) and carboplatin (area under the concentration time curve [AUC] of 6
Secondary Outcomes (1)
To determine the recommended Phase 2 dose of CI 1033 in combination with paclitaxel and carboplatin for patients with advanced NSCLC; to further define the safety profile of the recommended Phase 2 dose combination in an expanded cohort (22 patients)
Interventions
Eligibility Criteria
You may qualify if:
- At least one target lesion that is unidimensionally measurable as defined by Response Evaluation Criteria in Solid Tumors (RECIST ; Appendix B.2 ) and has not been previously irradiated; a tumor that expresses at least one member of the erbB family of receptors (as determined by immunohistochemical evaluation by a Sponsor-designated core laboratory)
You may not qualify if:
- Prior chemotherapy, biologic therapy, immunotherapy, treatment with Herceptin, or treatment with investigational agents (including CI 1033); hormonal therapy within 28 days prior to baseline disease assessment (to exclude the possibility of a hormone-withdrawal response); prior definitive radiation therapy to the primary cancer site; not yet recovered from the acute effects of surgery or palliative radiotherapy; brain metastases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (7)
Pfizer Investigational Site
Tampa, Florida, 33612, United States
Pfizer Investigational Site
Park Ridge, Illinois, 60068, United States
Pfizer Investigational Site
Skokie, Illinois, 60076, United States
Pfizer Investigational Site
Louisville, Kentucky, 40202, United States
Pfizer Investigational Site
Louisville, Kentucky, 40207, United States
Pfizer Investigational Site
Houston, Texas, 77030, United States
Pfizer Investigational Site
Hamilton, Ontario, L8V 5C2, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 15, 2005
Study Start
December 1, 2002
Study Completion
October 1, 2005
Last Updated
November 8, 2006
Record last verified: 2006-01