Study of DN101 and Taxotere in Patients With Advanced Non-Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novacea
• Collaborator: Aventis Pharmaceuticals
• Treatments: Calcitriol; Docetaxel

Criteria

Inclusion Criteria:

• Histopathologically or cytologically proven non-small cell carcinoma of the lung (NSCLC), either Stage IIIB or Stage IV, that has progressed on or after first or second-line chemotherapy

• Measurable disease by RECIST criteria

• Eastern Cooperative Oncology Group (ECOG) Performance Status < 1

• Life expectancy > 3 months

• Age > 18 years

• Agrees to use adequate contraception throughout the treatment period and for at least 6 months following treatment

• Able to give informed patient consent