Clinical trial · Interventional
A Long Term Safety Study With Atrasentan
A Phase II/III Extension Study to Evaluate the Safety and Tolerability of Atrasentan
NCT00127478CI-TRIAL-00001000completedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atrasentan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (8)
- measure
- Adverse events
- timeFrame
- Every 12 weeks
- measure
- Serious adverse events
- measure
- Oncology-related events (OREs)
- measure
- Deaths
- measure
- Study drug exposure
- measure
- Change from baseline in Karnofsky performance status
- measure
- Vital signs
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.