A Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Active Biotech AB
Study ID
NCT01234311
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • tasquinimod — DRUG
    Tasquinimod up to a maximum maintenance dose of 1 mg once daily, administrated orally (capsule)
  • Placebo — DRUG

Study Details

This is a Phase 3 randomized, double blind, placebo controlled study of tasquinimod in asymptomatic to mildly symptomatic patients with metastatic CRPC to confirm the effect of tasquinimod on delaying disease progression compared with placebo. Approximately 1200 eligible patients with metastatic CRPC will be randomly assigned in a 2:1 ratio to 1 of 2 treatment groups: Treatment Group A (tasquinimod 0.25, 0.5, or 1 mg/day; n=800) or Treatment Group B (placebo; n=400).

Key Dates

Start date
Mar 31, 2011
Status verified
Oct 2015
Primary completion
Feb 28, 2015
Completion
Aug 31, 2015

Study Design

Enrollment
1,245 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: placebo
    Matching placebo
  • Experimental: tasquinimod
    Tasquinimod up to a maximum maintenance dose of 1 mg once daily, administrated orally (capsule)

Primary Outcome Measure

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men with Metastatic Castrate Resistant Prostate Cancer [ Time Frame: 5 years ]

Locations (34)

FacilityCityStateZIPSite coordinators
-TucsonArizona--
-OxnardCalifornia--
-Santa MonicaCalifornia--
-Santa RosaCalifornia--
-WellingtonFlorida--
-AtlantaGeorgia--
-MeridianIdaho--
-Melrose ParkIllinois--
-Park RidgeIllinois--
-JeffersonvilleIndiana--
-BaltimoreMaryland--
-RockvilleMaryland--
-BostonMassachusetts--
-Jefferson CityMissouri--
-Las VegasNevada--
-HackensackNew Jersey--
-LawrencevilleNew Jersey--
-BuffaloNew York--
-PoughkeepsieNew York--
-ConcordNorth Carolina--
-DurhamNorth Carolina--
-RaleighNorth Carolina--
-SpringfieldOregon--
-Bala-CynwydPennsylvania--
-LancasterPennsylvania--
-PittsburghPennsylvania--
-Myrtle BeachSouth Carolina--
-NashvilleTennessee--
-DallasTexas--
-Salt Lake CityUtah--
-FairfaxVirginia--
-NorfolkVirginia--
-SalemVirginia--
-BurienWashington--

Find similar trials in Tucson, AZ

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology

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