Research Study for Patients With Metastatic Renal Cell Carcinoma

NCT00110344 | Terminated Phase 2

• 1 other identifier: 11547
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carcinoma, Renal Cell

Keywords

Cancer

Outcome Measures

Primary Outcomes (1)

• Best Overall Response Rate (complete and partial response rate)

  During study treatment or within 30 days after termination of active therapy

Secondary Outcomes (4)

• Progression-free survival

  Last date of tumor assessment

• Overall response rate

  Last day of tumor assessement

• Time to response

  throughout study

• Safety

  all visits

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: Nexavar (Sorafenib, BAY43-9006)

Arm 2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Nexavar (Sorafenib, BAY43-9006) DRUG

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.

Arm 1

Placebo DRUG

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 2

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Boston, Massachusetts, 02115-6084, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasms

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; 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

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 Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2005
• First Posted: May 9, 2005
• Study Start: November 1, 2005
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: October 11, 2013

Record last verified: 2013-10

Locations

US (1)