Study of DN101 and Taxotere in Patients With Advanced Non-Small Cell Lung Cancer
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.
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
- Enrollment
- 80 participants
Conditions and interventions
Conditions
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.