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A Study Looking at Novel Scheduling of Cabazitaxel for Patients With Metastatic Prostate Cancer

NCT01541007 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-11-02

No results posted yet for this study

Summary

Cabazitaxel has shown significant efficacy as second line chemotherapy after Docetaxel in men with metastatic castration resistant prostate cancer. This was demonstrated in the Tropic Study where Cabazitaxel showed survival superiority compared to mitoxantrone. Almost one in 4 patients treated with Cabazitaxel in this study required dose reductions or dose delays or stopped treatment due to toxicity. ConCab examines another scheduling for cabazitaxel to see if we can improve tolerability so that patients will receive a higher percentage of the treatment as planned.

Conditions

  • Metastatic Castration Resistant Prostate Cancer

Interventions

DRUG

Cabazitaxel

25 mg/m2 every three weeks

DRUG

weekly cabazitaxel

10 mg/m2 dag 1,8,15,22. Cycle length is 6 weeks

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Jeffrey Yachnin M.D., PhD.

    lead OTHER

Principal Investigators

  • Jeffrey R Yachnin, MD, PhD · Karolinska University Hosptial

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • Sweden

Study Locations

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Entities

Companies

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 NCT01541007 on ClinicalTrials.gov