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DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (AIPC Study of Calcitriol Enhancing Taxotere [ASCENT-2])

NCT00273338 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2007-11-06

No results posted yet for this study

Summary

The primary objective of this study is:

* To evaluate the effect of DN-101 in combination with docetaxel (ASCENT regimen) on survival in metastatic androgen-independent prostate cancer

The secondary objectives of this study are:

* To determine the effect of the ASCENT regimen on the rate of thromboembolic events (blood clots)
* To determine the effect of the ASCENT regimen on prevention of skeletal-related events (fractures)
* A Separate sub-study will be conducted at selected study sites in North America to determine the population PK of DN-101.

Conditions

Interventions

DRUG

calcitriol

DRUG

docetaxel

Sponsors & Collaborators

  • Novacea

    lead INDUSTRY

Principal Investigators

  • Howard I. Scher, MD · Sidney Kimmel Center for Prostate and Urologic Cancers, Memorial Sloan Kettering Cancer Center

  • Kim N. Chi, M.D. · British Columbia Cancer Agency - Vancouver Centre

  • Ronald De-Wit, M.D. · Erasmus University Medical Center (Netherlands)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Completion
2007-11-30

Countries

  • United States
  • Canada
  • Czechia
  • Germany
  • Hungary
  • Puerto Rico
  • Romania
  • Serbia and Montenegro
  • Slovakia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00273338 on ClinicalTrials.gov