PH 1 Evaluation Of Oral CI-1033 In Combination With Paclitaxel/ Carboplatin As 1st Line Chemotherapy In NSCLC Patients

Completed · Phase 1

Conditions studied: Carcinoma, Non-Small Cell Lung

In brief

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.

Key facts

Study ID

NCT00174356

Run by

Pfizer

People needed

39

Starts

2002-12-01

Expected to finish

2005-10-01

Last updated by the study team

2006-11-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Pfizer Investigational Site — Tampa, Florida, United States
• Pfizer Investigational Site — Park Ridge, Illinois, United States
• Pfizer Investigational Site — Skokie, Illinois, United States
• Pfizer Investigational Site — Louisville, Kentucky, United States
• Pfizer Investigational Site — Louisville, Kentucky, United States
• Pfizer Investigational Site — Houston, Texas, United States
• Pfizer Investigational Site — Hamilton, Ontario, Canada

Full record on ClinicalTrials.gov

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