Overview

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

Status:
Completed

Trial end date:
2005-10-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Pfizer

Treatments:

Albumin-Bound Paclitaxel
Canertinib dihydrochloride
Carboplatin
Paclitaxel

Criteria

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.