Study of DN101 and Taxotere in Patients With Advanced Non-Small Cell Lung Cancer
Status:
Completed
Trial end date:
2005-12-01
Target enrollment:
Participant gender:
Summary
This Phase 1/2 clinical trial is a multi-center, open-label study with three main objectives.
The first (Phase 1A) is to determine the maximum-tolerated dose of DN-101 when administered
in combination with Taxotere (docetaxel) every three weeks (closed). The second is to
determine the maximum-tolerated dose of DN-101 when administered weekly in combination with
Taxotere(docetaxel)devery three weeks (open). The third is to evaluate the safety and
objective tumor response rate of the combination in NSCLC. DN-101 doses will be escalated at
three dosing levels. Patients will receive oral DN-101 on day one, followed by intravenous
docetaxel on day two of a 21-day cycle. Treatment cycles will be repeated at the same dose
level each 21 days until disease progression or unacceptable toxicity.