Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00066885 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Carcinoma, Non-Small Cell Lung, sponsored by Novacea.

Completed
Registry status
Phase 1
Development phase
80
Enrollment target
11
Study locations

NCT00066885 is a Phase 1 study of Carcinoma, Non-Small Cell Lung that has completed, run by Novacea. The registered enrollment target is 80 participants, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (75% lower). The trial reports 11 study locations across 8 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00066885, a Phase 1 study of Carcinoma, Non-Small Cell Lung, has completed, sponsored by Novacea.

COMPLETED
Registry status
Phase 1
Development phase
80 participants
Enrollment target
11
Study locations

Study 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.

Conditions Studied

Carcinoma, Non-Small Cell Lung

Interventions

  • DRUG calcitriol + docetaxel

Study Locations (11)

Washington

  • Swedish Cancer Institute - Seattle
  • Northwest Cancer Specialists, P.C. - Vancouver
  • Yakima Regional Cancer Care Center - Yakima

California

  • Alta Bates Comprehensive Cancer Center - Berkeley
  • Kaiser Permanente Medical Center (Northern California) - Vallejo

Colorado

  • Rocky Mountain Cancer Center - Denver

New York

  • New York Oncology Hematology, P.C. - Albany Regional Cancer Center - Albany

North Carolina

  • Piedmont Hematology Oncology Associates, PLLC - Winston-Salem

Oklahoma

  • Cancer Care Associates - Tulsa

Oregon

  • Kaiser Permanente Northwest - Portland

South Carolina

  • Cancer Centers of the Carolinas - Greenville

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2003-06
Est. Completion 2005-12
Phase Phase 1

Sponsor

Novacea

3 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00066885

The ClinicalTrials.gov registry entry for NCT00066885 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (75% lower). The listed sponsor is Novacea, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 1 intervention - of which calcitriol + docetaxel is the first listed.

NCT00066885 reports 11 study locations spanning 8 distinct geographic areas - top geographies include Washington, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT00066885 about?

NCT00066885 is a clinical study titled "Study of DN101 and Taxotere in Patients With Advanced Non-Small Cell Lung Cancer". 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-tolera...

What is the current status of trial NCT00066885?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2003-06. Estimated completion is 2005-12.

What conditions does trial NCT00066885 study?

This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.

What interventions are being tested in trial NCT00066885?

The interventions under investigation include: calcitriol + docetaxel (DRUG).

Who is sponsoring clinical trial NCT00066885?

This trial is sponsored by Novacea, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00066885 being conducted?

This trial has 11 study locations across California, Colorado, New York, North Carolina, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Carcinoma, Non-Small Cell Lung

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Carcinoma, Non-Small Cell Lung

All registered trials for this condition

California

All trials with a study site in California

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.