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

This study has been terminated.
(DSMB)
Sponsor:
Information provided by:
Novacea
ClinicalTrials.gov Identifier:
NCT00273338
First received: December 14, 2005
Last updated: November 2, 2007
Last verified: November 2007
  Purpose

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.

Condition Intervention Phase
Prostate Cancer
Drug: calcitriol
Drug: docetaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Open-Label Study Evaluating DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (ASCENT-2)

Resource links provided by NLM:


Further study details as provided by Novacea:

Estimated Enrollment: 1200
Study Start Date: January 2006
Study Completion Date: November 2007
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histopathologically or cytologically proven adenocarcinoma of the prostate
  • Documented metastatic prostate adenocarcinoma
  • Documented progression while on androgen ablation therapy detected by rising prostate specific antigen (PSA) and/or imaging
  • Age >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status <= 2
  • Adequate hematologic, renal and hepatic function
  • Life expectancy >= 3 months

Exclusion Criteria:

  • Prior chemotherapy, except estramustine
  • Prior chemotherapy with docetaxel
  • Prior isotope therapy (e.g., strontium-89, samarium-153, etc.)
  • One or more contraindications to the use of corticosteroids
  • History of cancer-related hypercalcemia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273338

  Show 223 Study Locations
Sponsors and Collaborators
Novacea
Investigators
Study Chair: Howard I. Scher, MD Sidney Kimmel Center for Prostate and Urologic Cancers, Memorial Sloan Kettering Cancer Center
Study Chair: Kim N. Chi, M.D. British Columbia Cancer Agency - Vancouver Centre
Study Chair: Ronald De-Wit, M.D. Erasmus University Medical Center (Netherlands)
  More Information

ClinicalTrials.gov Identifier: NCT00273338     History of Changes
Other Study ID Numbers: 011-007 
Study First Received: December 14, 2005
Last Updated: November 2, 2007
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Novacea:
Androgen-independent Prostate Cancer (AIPC)
Prostate Cancer
DN-101
calcitriol
Taxotere
docetaxel

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Androgens
Calcitriol
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Vasoconstrictor Agents
Vitamins
Micronutrients
Growth Substances
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 28, 2016