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

Completed · Phase 1/Phase 2

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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.

Key facts

Study ID

NCT00066885

Run by

Novacea

People needed

80

Starts

2003-06-01

Expected to finish

2005-12-01

Last updated by the study team

2007-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Alta Bates Comprehensive Cancer Center — Berkeley, California, United States
• Kaiser Permanente Medical Center (Northern California) — Vallejo, California, United States
• Rocky Mountain Cancer Center — Denver, Colorado, United States
• New York Oncology Hematology, P.C. - Albany Regional Cancer Center — Albany, New York, United States
• Piedmont Hematology Oncology Associates, PLLC — Winston-Salem, North Carolina, United States
• Cancer Care Associates — Tulsa, Oklahoma, United States
• Kaiser Permanente Northwest — Portland, Oregon, United States
• Cancer Centers of the Carolinas — Greenville, South Carolina, United States
• Swedish Cancer Institute — Seattle, Washington, United States
• Northwest Cancer Specialists, P.C. — Vancouver, Washington, United States
• Yakima Regional Cancer Care Center — Yakima, Washington, United States

Full record on ClinicalTrials.gov

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