MRI Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma

The University of Chicago

Status and phase: Completed; Phase 3

Conditions: Metastatic Renal Cell Carcinoma

Treatments: Drug: placebo; Drug: Sorafenib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00606866

12977A

Details and patient eligibility

About

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

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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57 participants in 3 patient groups, including a placebo group

I

Placebo Comparator group

Description:

placebo pill

Treatment:

Drug: placebo

II

Active Comparator group

Description:

Sorafenib, 200 mg bid

Treatment:

Drug: Sorafenib

Drug: Sorafenib

III

Active Comparator group

Description:

Sorafenib, 400 mg bid

Treatment:

Drug: Sorafenib

Drug: Sorafenib