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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small Cell Lung

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Trial Information

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


Inclusion Criteria:



- 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)

Exclusion Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A4161001

NCT ID:

NCT00174356

Start Date:

December 2002

Completion Date:

October 2005

Related Keywords:

  • Carcinoma, Non-Small Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung

Name

Location

Pfizer Investigational SiteCrestview Hills, Kentucky  41017
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteClearwater, Florida  33761