Official Title: “A Phase II Uncontrolled Study of BAY 73-4506 in Previously Untreated Patients With Metastatic or Unresectable Renal Cell Cancer ( RCC)”

This is a uncontrolled, open-label, non-randomized Phase II study of oral BAY 73-4506 to evaluate the response rate of BAY 73-4506 in previously untreated patients with metastatic or unresectable Renal Cell Cancer (RCC).

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2008

The final analysis of efficacy will be performed after last patient has been treated for at least 6 months. Additional periodic safety and efficacy data reviews will be perormed for any patients continuing to receive study drug afterwards.

Intervention(s) in this Clinical Trial

• Drug: BAY 73-4506
  • Patients will be treated with BAY 73-4506 160 mg po qd for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off). Patients will continue treatment with BAY 73-4506 until disease progression, intolerable toxicity, or patient refusal to continue with the study or investigator decision to remove the patient from study.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1

Primary Measures

• Response rate of patients with advanced RCC to BAY 73-4506.
  • Time Frame: Every 8 weeks for the first 6 cycles then every 12 weeks
    Safety Issue?: No

Secondary Measures

• Progression-free survival
  • Time Frame: Every 8 weeks for the first 6 cycles then every 12 weeks
    Safety Issue?: No
• Time to progression
  • Time Frame: Every 8 weeks for the first 6 cycles then every 12 weeks
    Safety Issue?: No
• Duration of response
  • Time Frame: Every 8 weeks for the first 6 cycles then every 12 weeks
    Safety Issue?: No
• Duration of stable disease
  • Time Frame: Every 8 weeks for the first 6 cycles then every 12 weeks
    Safety Issue?: No

Inclusion Criteria:

• Male or female patients > 18 years of age.
• Patients, who suffer from unresectable and/or metastatic, measurable predominantly clear cell RCC histologically or cytologically documented. Patients with rare subtypes of RCC such as pure papillary cell tumor, mixed tumor containing predominantly sarcomatoid cells, Bellini carcinoma, medullary carcinoma, or chromophobe oncocytic tumors are excluded from study participation.
• Patients must be previously untreated for advanced disease. Prior palliative radiation therapy is allowed if the target lesion(s) are not included within the radiation field and no more than 30% of the bone marrow is irradiated.
• Patients who have at least one uni-dimensional measurable lesion by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST).
• Patients with "Intermediate" or "Low" risk per the Motzer score.
• Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate bone marrow, renal and hepatic function

Exclusion Criteria:

• Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
• Patients who have received prior systemic treatment regimens for RCC. Prior systemic therapy is defined as the following: a single chemotherapy agent (or regimen), a single immunotherapy agent (or regimen) or a single investigational treatment agent (or regimen), any anti-VEGF therapy (including bevacizumab, sunitinib and sorafenib) or any mTOR inhibitor therapy (including temsirolimus). Megestrol acetate or medroxyprogesterone, used as a single agent for the first line treatment of RCC will not constitute one prior systemic therapy.
• Cardiac arrhythmias requiring anti-arrhythmics (excluding beta blockers or digoxin), symptomatic coronary artery disease
• History of cardiac disease or congestive heart failure >NYHA class 2. Patients must not have unstable angina (anginal symptoms at rest) or new-onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
• Uncontrolled hypertension defined as systolic blood pressure 150 mmHg or diastolic pressure 90 mmHg, despite optimal medical management. -Cardiac ventricular arrhythmias requiring anti- arrhythmic therapy.
• Active clinically serious infections (> grade 2 NCI-CTC version 3.0).
• History of HIV infection or chronic hepatitis B or C.
• Known history or symptomatic metastatic brain or meningeal tumours (head CT or MRI at screening to confirm the absence of CNS disease if patient has symptoms suggestive or consistent with CNS disease).
• Patients with seizure disorder requiring medication (such as steroids or anti- epileptics).
• History of organ allograft.
• Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study.
• Serious, non-healing wound, ulcer, or bone fracture.
• Patients undergoing renal dialysis.
• Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
• Known or suspected allergy to the investigational agent or any agent given in association with this trial.
• Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
• Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and for at least 3 months after completion of study drug.The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
• Investigational drug therapy outside of this trial during or within 4 weeks of study entry
• Prior exposure to the study drug.
• Radiotherapy during study or within 3 weeks of start of study drug. Palliative radiotherapy will be allowed as described in the Prior and Concomitant Therapy section.
• Major surgery open biopsy or significant traumatic injury within 4 weeks of start of study
• Autologous bone marrow transplant or stem cell rescue within 4 months of study
• Patients unable to swallow oral medications
• Any malabsorption condition

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Overall Contact: Bayer Clinical Trials Contact  clinical-trials-contact@bayerhealtcare.com

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00664326

Study ID Number: 11726

ClinicalTrials.gov Identifier: NCT00664326

Health Authority: United States: Food and Drug Administration

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