A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable RCC

Official Title: “A Phase II Uncontrolled Study of BAY73-4506 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 BAY73-4506 to evaluate the response rate of BAY73-4506 in previously untreated patients with metastatic or unresectable renal cell cancer (RCC).

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 performed for any patients continuing to receive study drug afterwards.

Intervention(s) in this Clinical Trial

• Drug: Regorafenib (BAY73-4506)
  • Patients will be treated with BAY73-4506 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 BAY73-4506 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 BAY73-4506
  • 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 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 as assessed by the following laboratory requirements to be conducted within 7 days prior to study drug treatment

Exclusion Criteria:

• Patients who have received prior systemic treatment regimens for RCC.
• Uncontrolled/unstable cardiac disease
• Uncontrolled hypertension
• Active clinically serious infections (> CTCAE grade 2 )
• History of HIV infection or chronic hepatitis B or C.
• Known history or symptomatic metastatic brain or meningeal tumours
• Patients with seizure disorder requiring medication
• Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding event >/= CTCAE Grade 3 within 4 weeks of first dose of study.
• Pregnant or breast-feeding patients

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 Investigator: Bayer Industry

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on February 09, 2012

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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