Adenocarcinoma, Prostate Cancer
Conditions
Keywords
Hormone Refractory Prostate Cancer, Adenocarcinoma of the Prostate
Brief summary
The primary purpose of the study is to evaluate long-term safety and tolerability of atrasentan 10 mg in men with hormone refractory prostate cancer.
Interventions
DRUGAtrasentan
Sponsors
Abbott
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Greater than or equal to 18 years, inclusive; * Subject is currently active in an atrasentan clinical study OR has histologically or cytologically documented diagnosis of prostate adenocarcinoma and is considered hormone refractory; * Karnofsky Performance Score greater than or equal to 60; * Adequate hematologic function and liver function tests; * No New York Heart Association (NYHA) class greater than or equal to 2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stratification by treatment group from prior study | — |
| Adverse events | Every 12 weeks |
| Serious adverse events | — |
| Oncology-related events (OREs) | — |
| Deaths | — |
| Study drug exposure | — |
| Change from baseline in Karnofsky performance status | — |
| Vital signs | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and laboratory parameters | Every 12 weeks |
Countries
Canada, France, Netherlands, United Kingdom, United States
Outcome results
None listed