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The CATCH Prostate Cancer Trial: Cabazitaxel And Tasquinimod in Men With Prostate Cancer

NCT01513733 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2018-09-04

No results posted yet for this study

Summary

The standard of care for men with metastatic CRPC in 2010 following progression on docetaxel is cabazitaxel or abiraterone acetate/prednisone. Based on results from two other studies, cabazitaxel and prednisone has become a standard second line chemotherapy regimen and becomes the backbone upon which to improve upon. Thus, the primary objective of this study is to determine the recommended dose of tasquinimod in combination with cabazitaxel and prednisone based on safety and tolerability in men with chemorefractory metastatic castration-resistant prostate cancer (CRPC).

Conditions

Interventions

DRUG

tasquinimod

tasquinimod 0.25 mg continuously

DRUG

tasquinimod 0.25 mg; 0.5 mg

tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg continuously, if tolerated

DRUG

tasquinimod 0.25 mg; 0.5 mg; 1.0 mg

tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg for 3 weeks followed by 1.0 mg continuously, if tolerated

Sponsors & Collaborators

  • Andrew J. Armstrong, MD

    lead OTHER

Principal Investigators

  • Andrew Armstrong, MD · Duke Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2015-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01513733 on ClinicalTrials.gov