A Long Term Safety Study With Atrasentan

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00127478
• Date of registration: 04/08/2005
• Prospective Registration: No
• Primary sponsor: Abbott
• Public title: A Long Term Safety Study With Atrasentan
• Scientific title: A Phase II/III Extension Study to Evaluate the Safety and Tolerability of Atrasentan
• Date of first enrolment: July 2001
• Target sample size: 166
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00127478
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2/Phase 3

Countries of recruitment

Canada, France, Netherlands, United Kingdom, United States

Contacts

• Name: Gary Gordon, MD
• Affiliation: Abbott

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer

Adenocarcinoma

Intervention(s)

Drug: Atrasentan

Primary Outcome(s)

Oncology-related events (OREs)

Serious adverse events

Change from baseline in Karnofsky performance status

Stratification by treatment group from prior study

Study drug exposure

Adverse events [Time Frame: Every 12 weeks]

Deaths

Vital signs

Secondary Outcome(s)

Safety and laboratory parameters [Time Frame: Every 12 weeks]

Secondary ID(s)

M01-304

Source(s) of Monetary Support

Please refer to primary and secondary sponsors