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A Study Evaluating the Pain Palliation Benefit of Adding Custirsen to Docetaxel Retreatment or Cabazitaxel as Second Line Therapy in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC)

NCT01083615 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2016-10-12

No results posted yet for this study

Summary

The purpose of this study is to determine if the addition of study drug (custirsen) can provide durable pain palliation for castrate resistant prostate cancer patients receiving docetaxel retreatment or cabazitaxel as a second line therapy.

Conditions

  • Castrate-Resistant Prostate Cancer
  • Hormone Refractory Prostate Cancer

Interventions

DRUG

custirsen sodium

An antisense oligonucleotide that blocks production of clusterin

DRUG

isotonic, 0.9% sodium chloride

Placebo for custirsen sodium

DRUG

docetaxel

DRUG

cabazitaxel

DRUG

prednisone

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    collaborator INDUSTRY

  • Achieve Life Sciences

    lead INDUSTRY

Principal Investigators

  • Tomasz M Beer, M.D. · Oregon Health and Science University

  • Sebastien J Hotte, M.D. · Juravinski Cancer Centre, McMaster University

  • Karim Fizazi, M.D., Ph.D. · Institut Gustave Roussy, University of Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United States
  • Canada
  • France
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01083615 on ClinicalTrials.gov