Efficacy Study of ABR-215050 to Treat Prostate Cancer

Conditions

• Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ABR-215050, tasquinimod — DRUG
  Gelatin capsules containing 0.25mg, 0.50mg, 1.0mg ABR-215050; 0.25mg/day taken orally once daily for 2 weeks, 0.50mg/day taken orally once daily for 2 weeks (dose-titration), and 1.0 mg/day taken once daily for 5 months (+6 months continuation)
• Placebo — DRUG
  Identical appearing gelatin capsules containing placebo

Study Details

To investigate ABR-215050 as a possible treatment for prostate cancer.

Key Dates

Start date

Dec 31, 2007

Status verified

Oct 2015

Primary completion

Jun 30, 2010

Completion

Aug 31, 2015

Study Design

Enrollment

206 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: A
• Placebo Comparator: B

Primary Outcome Measure

Disease progression, defined as onset of tumor-related cancer pain, measurable disease progression, bone metastases or other non-target lesions, need for radiotherapy or surgery for pathological fracture or spinal cord compression [ Time Frame: 3 months, 6 months; continuation phase every 3 months ]

Locations (54)

Find similar trials in Anchorage, AK

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