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Prostate

A Phase 3, Randomized, Open-Label Study Evaluating DN-101 in Combination with Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (ASCENT-2)

Unique Data Set IDProstat_Novacea_2006_89
DownloadableYes
SponsorNovacea, Inc.Data ProviderMemorial Sloan Kettering Cancer CenterTotal Study Enrolled Patients953Comparator (Control) Arm Enrolled Patients476RandomizationYesClinicalTrial.gov IDNCT00273338ClinicalTrial.gov URLhttp://clinicaltrials.gov/show/NCT00273338
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeChemotherapy, DrugData Set TypeOther

Clinical Trial Title

A Phase 3, Randomized, Open-Label Study Evaluating DN-101 in Combination with Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (ASCENT-2)

Trial Summary and Conditions

This dataset was part of the training data curated for the Prostate Cancer DREAM Challenge. To view the curated training dataset, which includes 3 mCRPC datasets from ProjectDataSphere.org, visit: https://www.projectdatasphere.org/projectdatasphere/html/content/149

This dataset was included in the Prostate Cancer Tumor Growth data cited in The Lancet Oncology manuscript: Estimation of tumour regression and growth rates during treatment in patients with advanced prostate cancer. To view the consolidated Prostate Cancer Tumor Growth data, visit: https://www.projectdatasphere.org/projectdatasphere/html/content/167

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.

Data Summary

Control arm data files include raw data on safety, efficacy, demographics, etc. (n=...)

Study Objectives

Effectiveness 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

Outcome Measures

Primary endpoint: Duration of Survival Secondary Efficacy Endpoints: 1) Thromboembolic Event (TE) Rate 2) Duration of Skeletal-related Event (SRE)-free Survival Safety Endpoints 1) Serious Adverse Events (SAEs) Rate 2) Gastrointestinal (GI) Event Rate Exploratory Endpoints 1) Quality of Life 2) Pain

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: 06-010A(1).pdf

CRF: CRF Placeholder.docx

DATA DICTIONARY: DN101_DataShpere_Dictionary_v3.0.xlsx

DATA (COMPARATOR ARM): datasets.zip