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

Sponsor
Ipsen
Study ID
NCT01732549
Phase
PHASE2
Status
Terminated

Conditions

  • Metastatic Castrate Resistant Prostate Cancer

Eligibility Criteria

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

Interventions

  • Tasquinimod — DRUG
    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.
  • Placebo — DRUG
    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

Study Details

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.

Key Dates

Start date
Jan 31, 2013
Status verified
Nov 2019
Primary completion
Feb 28, 2015
Completion
May 31, 2015

Study Design

Enrollment
144 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tasquinimod
    1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg or 1 mg per day) until disease progression or toxicity or patient's willingness to stop.
  • Placebo Comparator: Placebo
    1 capsule daily, taken orally with water and food until disease progression or toxicity or patient's willingness to stop.

Primary Outcome Measure

Time to Radiological Progression Free Survival [PFS] [ Time Frame: Every 8 weeks until disease progression documentation (approximately up to 2.5 years) ]

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