Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00273338
Recruitment Status : Terminated (DSMB)
First Posted : January 9, 2006
Last Update Posted : November 6, 2007
Information provided by:

Brief 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: calcitriol Drug: docetaxel Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : January 2006
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00273338

Show Show 223 study locations
Sponsors and Collaborators
Layout table for investigator information
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)
Layout table for additonal information Identifier: NCT00273338    
Other Study ID Numbers: 011-007
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: November 6, 2007
Last Verified: November 2007
Keywords provided by Novacea:
Androgen-independent Prostate Cancer (AIPC)
Prostate Cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Vasoconstrictor Agents
Growth Substances
Bone Density Conservation Agents