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Completed Phase 1Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT00066885

Public ClinicalTrials.gov record NCT00066885. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 27, 2026, 3:20 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1/2 Multicenter, Open Label, Dose Ranging Study of DN-101 and Taxotere® in Patients With Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC) Who Have Failed Previous Therapy With Platinum-Based Chemotherapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00066885
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Novacea
Industry
Enrollment
80 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 31, 2003
Primary completion
Not listed
Completion
Nov 30, 2005
Last update posted
May 6, 2007

2003 – 2005

United States locations

U.S. sites
11
U.S. states
8
U.S. cities
11
Facility City State ZIP Site status
Alta Bates Comprehensive Cancer Center Berkeley California 94704 —
Kaiser Permanente Medical Center (Northern California) Vallejo California 94589 —
Rocky Mountain Cancer Center Denver Colorado — —
New York Oncology Hematology, P.C. - Albany Regional Cancer Center Albany New York — —
Piedmont Hematology Oncology Associates, PLLC Winston-Salem North Carolina — —
Cancer Care Associates Tulsa Oklahoma — —
Kaiser Permanente Northwest Portland Oregon 97227 —
Cancer Centers of the Carolinas Greenville South Carolina — —
Swedish Cancer Institute Seattle Washington 98104 —
Northwest Cancer Specialists, P.C. Vancouver Washington — —
Yakima Regional Cancer Care Center Yakima Washington 98902 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00066885, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 6, 2007 · Synced Sep 27, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00066885 live on ClinicalTrials.gov.

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