Overview

This trial is active, not recruiting.

Condition carcinoma, renal cell
Treatment regorafenib (stivarga, bay73-4506)
Phase phase 2
Sponsor Bayer
Start date April 2008
End date May 2009
Trial size 49 participants
Trial identifier NCT00664326, 11726, 2008-000107-28

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants received Regorafenib 160 mg per os (po) every day (qd) for 3 weeks on 1 week off of every 4 week cycle
regorafenib (stivarga, 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.

Primary Outcomes

Measure
Objective Tumor Response
time frame: From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks
Tumor Response
time frame: From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks

Secondary Outcomes

Measure
Disease Control
time frame: From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks
Overall Survival
time frame: From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009).
Progression-free Survival (PFS)
time frame: From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks
Time to Progression (TTP)
time frame: From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks
Duration of Response
time frame: From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks
Duration of Stable Disease (SD)
time frame: From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009). Assessed every 8 weeks for 6 months, then every 12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Male or female patients >/= 18 years of age. - Patients, who suffer from unresectable and/or metastatic, measurable predominantly clear cell RCC (renal cell carcinoma 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 computed tomography (CT-scan) or magnetic resonance imaging (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 (> Common Terminology Criteria for Adverse Events [CTCAE] grade 2 ) - History of human immunodeficiency virus (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

Additional Information

Official title A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable Renal Cell Cancer (RCC)
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Bayer.