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

Phase 3

Terminated

• Conditions: Prostate Cancer

• Registration Number: NCT00273338
• Lead Sponsor: Novacea

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-12-14
• Study Start: 2006-01
• Study First Submitted QC: 2006-01-05
• Study First Posted: 2006-01-09
• Status Verified: 2007-11
• Study Completion: 2007-11
• Last Update Submitted: 2007-11-02
• Last Update Posted: 2007-11-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 1200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (212)

Birmingham Hematology & Oncology Associates, LLC; 🇺🇸 Birmingham, Alabama, United States

Northwest Alabama Cancer Center; 🇺🇸 Muscle Shoals, Alabama, United States

Alaska Clinical Research Center; 🇺🇸 Anchorage, Alaska, United States

Hematology Associates - AOA; 🇺🇸 Phoenix, Arizona, United States

Premiere Oncology of Arizona; 🇺🇸 Scottsdale, Arizona, United States

Northern Arizona Hematology & Oncology Associates, AOA; 🇺🇸 Sedona, Arizona, United States

Southern Arizona VA Healthcare System; 🇺🇸 Tucson, Arizona, United States

U of Arizona / Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

Genesis Cancer Center; 🇺🇸 Hot Springs, Arkansas, United States

Tower Cancer Research Foundation; 🇺🇸 Beverly Hills, California, United States

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