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 )

First Received: December 14, 2005 Last Updated: November 2, 2007 History of Changes

Sponsored by:	Novacea
Information provided by:	Novacea
ClinicalTrials.gov Identifier:	NCT00273338

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Calcitriol Docetaxel

U.S. FDA Resources

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
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

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

Show 226 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

No publications provided

Study ID Numbers:	011-007
Study First Received:	December 14, 2005
Last Updated:	November 2, 2007
ClinicalTrials.gov Identifier:	NCT00273338 History of Changes
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

Study placed in the following topic categories:

Genital Neoplasms, Male
Prostatic Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Urogenital Neoplasms
Trace Elements
Cardiovascular Agents
Genital Diseases, Male

Hormones
Calcitriol
Docetaxel
Calcium, Dietary
Vitamins
Vasoconstrictor Agents
Micronutrients
Prostatic Neoplasms
Androgens

Additional relevant MeSH terms:

Prostatic Diseases
Genital Neoplasms, Male
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Bone Density Conservation Agents
Hormones
Calcitriol
Docetaxel
Membrane Transport Modulators

Neoplasms by Site
Vitamins
Therapeutic Uses
Vasoconstrictor Agents
Micronutrients
Growth Substances
Cardiovascular Agents
Genital Diseases, Male
Pharmacologic Actions
Neoplasms
Prostatic Neoplasms
Androgens

ClinicalTrials.gov processed this record on September 01, 2009