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A Proof of Concept Study of Maintenance Therapy With Tasquinimod in Patients With Metastatic Castrate-resistant Prostate Cancer Who Are Not Progressing After a First Line Docetaxel Based Chemotherapy

NCT01732549 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2019-11-22

Study results available
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Summary

The purpose of this study is to confirm that tasquinimod used as maintenance therapy is active and tolerable in patients with metastatic castrate-resistant prostate cancer not progressing after a first chemotherapy with docetaxel.

Conditions

  • Metastatic Castrate Resistant Prostate Cancer

Interventions

DRUG

Tasquinimod

A patient's dose will escalate from one level to the next, once tolerability of the current dose is established. If tolerability issues arise at 0.5 or 1 mg/day, patients will have their dose reduced to 0.25 or 0.5 mg/day, respectively.

DRUG

Placebo

Placebo capsules are identical to tasquinimod capsules in appearance and excipients but exclude the active compound (tasquinimod), to be taken orally once a day with water and food

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-02-28
Completion
2015-05-31

Countries

  • Belgium
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Italy
  • Lithuania
  • Poland
  • Spain
  • United Kingdom

Study Locations

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Entities

Drugs
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 NCT01732549 on ClinicalTrials.gov