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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00174356
First received: September 9, 2005
Last updated: November 6, 2006
Last verified: January 2006

September 9, 2005
November 6, 2006
December 2002
Not Provided
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
Same as current
Complete list of historical versions of study NCT00174356 on ClinicalTrials.gov Archive Site
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)
  • 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);
  • t
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Non-Small Cell Lung
  • Drug: CI 1033
  • Drug: PACLITAXEL
  • Drug: CARBOPLATIN
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
October 2005
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00174356
A4161001
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP