Research Study for Patients With Metastatic Renal Cell Carcinoma

Sponsor

Bayer (Industry)

Overall Status

Terminated

CT.gov ID

NCT00110344

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Renal Cell	Drug: Nexavar (Sorafenib, BAY43-9006) Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase II Study of BAY 43-9006 Prior to and Following Nephrectomy in Patients With Metastatic Renal Cell Carcinoma.

Study Start Date :

Nov 1, 2005

Actual Primary Completion Date :

Jun 1, 2006

Actual Study Completion Date :

Jun 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Nexavar (Sorafenib, BAY43-9006) Cycle 1. Patients are randomized in a double-blind fashion to receive either Nexavar (Sorafenib, BAY 43-906; this arm) or matching placebo (see below) for 14 days. Dose range will be depending on hematologic and other toxicity between 400 mg (2 tablets of 200 mg) orally twice bid and 400 mg orally every 2 days. Cycle 2: patients who are eligible undergo nephrectomy. After the post-nephrectomy recovery period, all patients will receive 400 mg of BAY 43-906, twice daily (administered as two 200 mg tablets) in an open-label fashion.Cycle 3+: 400 mg of BAY 43-906, twice daily (administered as two 200 mg tablets) in an open-label fashion.
Placebo Comparator: Arm 2	Drug: Placebo Cycle 1. Patients are randomized in a double-blind fashion to receive either Nexavar (see above) or matching placebo (this arm) for 14 days. Dose range will be depending on hematologic and other toxicity between 400mg (2 tablets of 200mg) orally twice bid and 400mg orally every 2 days. Cycle 2 and 3: see above (no placebo application)

Arm

Intervention/Treatment

Experimental: Arm 1

Drug: Nexavar (Sorafenib, BAY43-9006)

Cycle 1. Patients are randomized in a double-blind fashion to receive either Nexavar (Sorafenib, BAY 43-906; this arm) or matching placebo (see below) for 14 days. Dose range will be depending on hematologic and other toxicity between 400 mg (2 tablets of 200 mg) orally twice bid and 400 mg orally every 2 days. Cycle 2: patients who are eligible undergo nephrectomy. After the post-nephrectomy recovery period, all patients will receive 400 mg of BAY 43-906, twice daily (administered as two 200 mg tablets) in an open-label fashion.Cycle 3+: 400 mg of BAY 43-906, twice daily (administered as two 200 mg tablets) in an open-label fashion.

Placebo Comparator: Arm 2

Drug: Placebo

Cycle 1. Patients are randomized in a double-blind fashion to receive either Nexavar (see above) or matching placebo (this arm) for 14 days. Dose range will be depending on hematologic and other toxicity between 400mg (2 tablets of 200mg) orally twice bid and 400mg orally every 2 days. Cycle 2 and 3: see above (no placebo application)

Outcome Measures

Primary Outcome Measures

Best Overall Response Rate (complete and partial response rate) [During study treatment or within 30 days after termination of active therapy]

Secondary Outcome Measures

Progression-free survival [Last date of tumor assessment]
Overall response rate [Last day of tumor assessement]
Time to response [throughout study]
Safety [all visits]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Exclusion Criteria:
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Boston	Massachusetts	United States	02115-6084

Sponsors and Collaborators

Bayer

Investigators

Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Bayer

ClinicalTrials.gov Identifier:

NCT00110344

Other Study ID Numbers:

11547

First Posted:

May 9, 2005

Last Update Posted:

Oct 11, 2013

Last Verified:

Oct 1, 2013

Keywords provided by Bayer

Cancer

Additional relevant MeSH terms:

Carcinoma

Carcinoma, Renal Cell

Sorafenib

Study Results

No Results Posted as of Oct 11, 2013