Clinical trial · Interventional
MRI Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma
Dynamic-Contrast Enhanced MRI Pharmacodynamic Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma
NCT00606866CI-TRIAL-00071778MRIcompletedPhase 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 purpose of this study is to determine maximum tumor shrinkage, time to progression, survival, drug concentration, and degree of skin toxicity.
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 |
|---|---|---|---|
| Metastatic Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Drug | — | UNRESOLVED |
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- I
- description
- placebo pill
- interventionNames
- Drug: placebo
- type
- ACTIVE_COMPARATOR
- label
- II
- description
- Sorafenib, 200 mg bid
- interventionNames
- Drug: Sorafenib
- type
- ACTIVE_COMPARATOR
- label
- III
- description
- Sorafenib, 400 mg bid
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed metastatic clear cell renal cell cancer; * At least one lesion that can be accurately measured in at least one dimension; * Patients must not have been treated with prior anti-timor kinase inhibitors or VEGF pathway inhibitors; * Age 18 and older; * ECOG performance status 0-2; * Blood pressure higher than 140/90 on 2 separate occasions not more than 6 weeks prior to enrollment and not less than 24 hours apart; * Normal organ function: total bilirubin less than upper limit of normal, AST less than 2.5 X upper limit of normal, creatinine less than 2.8 mg/dl; * Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation; * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Chemotherapy or radiotherapy within 4 weeks prior to entering the study; * Any other investigational agents; * Known brain metastases; * Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; * Pregnancy.
References
Publications (0)
Data not yet available
No reference posted for this study.