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Type(s) of Cancer
Prostate
Study Phase
Phase 3
Study Completion Date
2006
NCT00273338Uploaded 03-31-2014
Available for Download
PDS UID: Prostat_Novacea_2006_89
A Phase 3, Randomized, Open-Label Study Evaluating DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (ASCENT-2)
Provider Information
Provider Data DescriptionEffectiveness The primary objective of this study is: To evaluate the efficacy of weekly DN-101 in combination with weekly docetaxel (the ASCENT regimen) in the treatment of metastatic AIPC as measured by duration of survival. The secondary objectives of this study are: 1) To determine the efficacy of ASCENT regimen as measured by thromboembolic event (TE) rate 2) To determine the efficacy of ASCENT regimen as measured by duration of skeletal-related event (SRE)-free survival The effect of the ASCENT regimen on quality of life (QOL), pain, and PSA will be evaluated as exploratory analyses. QOL (FACT-P and related questions, including measurement of fatigue using the Brief Fatigue Inventory) and pain (the Brief Pain Inventory) will only be assessed at sites in North America. Safety To evaluate the safety and tolerability of the ASCENT regimen. In particular, the serious adverse event (SAE) rate and gastrointestinal (GI) event rate will be specified as safety endpoint analyses. Note The following sub-studies will be performed under separate protocols at selected sites in North America: - Population pharmacokinetics (PK) - Biomarkers
SponsorNovacea, Inc.
Data ProviderMemorial Sloan Kettering Cancer Center
Partial set or SubsetN/A
Patients in dataset953
# of Patients Control476
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/9ate-8g38
CDISC StandardRaw or Case Report Form data
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe 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.
ConditionsProstate Cancer
Intervention TypeDrug: calcitriol
Drug: docetaxel
Drug(s)N/A
Total Enrolled1200
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionN/A
Secondary IDN/A
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)United States
Canada
Czech Republic
Former Serbia and Montenegro
Germany
Hungary
Puerto Rico
Romania
Slovakia
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOL06-010A(1).pdf
CRFCRF Placeholder.docx
DATA DICTIONARYDN101_DataShpere_Dictionary_v3.0.xlsx
DATA (COMPARATOR ARM)datasets.zip
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