Clinical trial · Interventional
Atrasentan in Treating Patients With Prostate Cancer
A Phase III Extension Study to Evaluate the Safety of 10 mg Atrasentan in Men With Hormone-Refractory Prostate Cancer
NCT00046943CI-TRIAL-00004439completedPhase 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase III trial to determine the effectiveness of atrasentan in treating patients who have prostate cancer that has not responded to hormone therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| atrasentan hydrochloride | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 19 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of hormone-refractory prostate cancer * Completed protocol ABBOTT-M00-211 or ABBOTT-M00-244 within the past 30 days * Disease progression OR * Active in trial when double-blind treatment period ended PATIENT CHARACTERISTICS: Age * 19 and over Performance status * Karnofsky 60-100% Life expectancy * Not specified Hematopoietic * WBC at least 3,000/mm3 * Absolute neutrophil count greater than 1,000/mm3 * Platelet count at least 100,000/mm3 * Hemoglobin at least 9 g/dL Hepatic * Bilirubin less than 1.5 mg/dL * AST and ALT no greater than 1.5 times upper limit of normal Renal * Creatinine clearance at least 40 mL/min Cardiovascular * No New York Heart Association class II-IV heart disease Pulmonary * No significant pulmonary disease requiring chronic or pulse steroid therapy within the past 3 months Other * Fertile patients must use 2 effective methods of contraception (1 must be barrier contraception) during and for 8 weeks after study * No reason that would preclude study * No significant comorbid condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * At least 4 weeks since other prior cytotoxic chemotherapy * No other concurrent cytotoxic chemotherapy Endocrine therapy * Not specified Radiotherapy * At least 4 weeks since prior radionuclides * No concurrent radionuclides Surgery * Not specified Other * At least 4 weeks since prior investigational agents * No concurrent antiretroviral therapy for HIV-positive patients * No concurrent participation in another investigational study
References
Publications (0)
Data not yet available
No reference posted for this study.