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

NCT00606866 | Completed Phase 3 DMC

• 1 other identifier: 12977A
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Renal Cell Carcinoma

Keywords

renal, metastatic, carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To predict which patients are most likely to experience tumor shrinkage.

  8 weeks

Study Arms (3)

I

PLACEBO COMPARATOR

placebo pill

Drug: placebo

II

ACTIVE COMPARATOR

Sorafenib, 200 mg bid

Drug: Sorafenib

III

ACTIVE COMPARATOR

Sorafenib, 400 mg bid

Drug: Sorafenib

Interventions

placebo DRUG

Placebo for four weeks

I

Sorafenib DRUG

Sorafenib 200 mg twice daily

II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead
• Bayer: collaborator

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasm Metastasis; Carcinoma

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 5, 2008
• Study Start: July 1, 2004
• Primary Completion: January 1, 2007
• Study Completion: June 1, 2008
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

US (1)