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

Novacea

Status and phase: Terminated; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: docetaxel; Drug: calcitriol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00273338

011-007

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)