stop_circleTerminated/Withdrawn

Carcinoma, Renal Cell

Bayer Identifier:

11547

ClinicalTrials.gov Identifier:

NCT00110344

EudraCT Number:

Not Available

EU CT Number:

Not Available
Research Study for Patients with Metastatic Renal Cell Carcinoma

Trial purpose

This study has been designed to study patients diagnosed with advanced renal cell cancer with the primary tumor in place.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Life expectancy of at least 12 weeks
    - Clinical, radiographic, or pathologic diagnosis of metastatic renal cell carcinoma (RCC). All renal cell histologies are allowed- Acceptable surgical risk in the judgment of the study investigator and consulting urological surgeon
    - At least one uni-dimensional measurable lesion outside the planned nephrectomy specimen
    - Patients who have an ECOG performance status of 0 or 1
  • - History of bleeding diathesis or unexpected surgical bleeding- Patients currently receiving treatment with or having a requirement for therapeutic anticoagulation
    - Prior therapy for RCC. Palliative radiation therapy for painful or unstable bone metastases is permitted provided that there is measurable metastatic disease outside the radiation field
    - Known history of HIV infection- Symptomatic metastatic brain or meningeal tumors, unless the patient is > 6 months from definitive therapy, has a CT or MRI scan within 6 weeks of study entry negative for brain metastases and is clinically stable with respect to the tumor at the time of study entry

Trial summary

Enrollment Goal
1
Trial Dates
November 2005 - June 2006
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Dana-Farber Cancer InstituteBoston, 02115-6084, United States

Primary Outcome

  • Best Overall Response Rate (complete and partial response rate)
    date_rangeTime Frame:
    During study treatment or within 30 days after termination of active therapy
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Progression-free survival
    date_rangeTime Frame:
    Last date of tumor assessment
    enhanced_encryption
    Safety Issue:
    no
  • Overall response rate
    date_rangeTime Frame:
    Last day of tumor assessement
    enhanced_encryption
    Safety Issue:
    no
  • Time to response
    date_rangeTime Frame:
    throughout study
    enhanced_encryption
    Safety Issue:
    no
  • Safety
    date_rangeTime Frame:
    all visits
    enhanced_encryption
    Safety Issue:
    yes

Trial design

A Phase II study of BAY 43-9006 prior to and following nephrectomy in patients with metastatic renal cell carcinoma.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.