Clinical trial · Interventional
BAY 56-3722 in Treating Patients With Recurrent, Unresectable, or Metastatic Kidney Cancer
Phase II Study of BAY 56-3722 in Patients With Recurrent, Unresectable, or Metastatic Renal Cell Carcinoma
NCT00040989CI-TRIAL-00011273withdrawnPhase 2ClinicalTrials.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: BAY 56-3722 may stop the growth of cancer cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of BAY 56-3722 in treating patients who have recurrent, unresectable, or metastatic kidney 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 |
|---|---|---|---|
| Recurrent Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage IV Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BAY 56-3722 | Drug | — | UNRESOLVED |
| enzyme inhibitor therapy | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed renal cell carcinoma (RCC) * Recurrent AND unresectable disease OR * Unresectable disease OR * Metastatic disease * At least 1 bidimensionally measurable lesion by CT scan or MRI * No metastatic brain or meningeal tumors unless more than 3 months since prior surgery and/or gamma knife radiosurgery, 2 subsequent negative imaging studies at least 4 weeks apart, clinically stable, and no concurrent corticosteroids or anticonvulsants PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST and ALT less than 2.5 times ULN (5 times ULN if liver metastases present) * No chronic hepatitis B or C Renal: * Creatinine no greater than 1.5 mg/dL * Calcium normal Cardiovascular: * No clinically evident congestive heart failure * No serious cardiac arrhythmias * No symptoms of coronary heart disease * No symptoms of ischemia Other: * HIV negative * No active infections requiring systemic antibacterial, antifungal, or antiviral therapy * No other malignancy within the past 3 years except carcinoma in situ of the cervix, adequately treated basal cell carcinoma, or superficial bladder tumors (Ta, Tis, or T1) * No substance abuse * No medical, psychological, or social conditions that would preclude study * No known or suspected allergy to study drug or any other study agents * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 6 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior anticancer vaccine therapy * No prior bone marrow transplantation or stem cell rescue * More than 4 weeks since prior thalidomide and bevacizumab * At least 4 weeks since prior interleukin-2 and interferon * No more than 2 prior regimens * No concurrent bone marrow transplantation or stem cell rescue Chemotherapy: * No prior cytotoxic chemotherapy * No concurrent cytotoxic chemotherapy Endocrine therapy: * See Disease Characteristics * No prior hormonal therapy for RCC * No concurrent hormonal therapy for RCC Radiotherapy: * See Disease Characteristics * More than 4 weeks since prior radiotherapy * No prior radiotherapy to indicator lesion unless progression is documented Surgery: * See Disease Characteristics * More than 3 weeks since prior major surgery Other: * At least 4 weeks since prior investigational anticancer drugs * No other concurrent investigational anticancer drugs
References
Publications (0)
Data not yet available
No reference posted for this study.