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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00606866

Acronym

MRI

Enrollment

Registered

2008-02-05

Start date

2004-07-31

Completion date

2008-06-30

Last updated

2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Renal Cell Carcinoma

Keywords

renal, metastatic, carcinoma

Brief summary

The purpose of this study is to determine maximum tumor shrinkage, time to progression, survival, drug concentration, and degree of skin toxicity.

Interventions

DRUGplacebo

Placebo for four weeks

DRUGSorafenib

Sorafenib 200 mg twice daily

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
To determine whether a new experimental MRI technique called Dynamic Contrast Enhanced MRI (DCE-MRI) can determine the best dose of sorafenib	8 weeks

Secondary

Measure	Time frame
To predict which patients are most likely to experience tumor shrinkage.	8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026