Clinical trial NCT00664326: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Renal Cell
Keywords: Renal Cell Carcinoma
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-22
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective Tumor Response
timeFrame: 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
measure: Tumor Response
timeFrame: 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
timeFrame: 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
measure: Overall Survival
timeFrame: From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009).
measure: Progression-free Survival (PFS)
timeFrame: 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
measure: Time to Progression (TTP)
timeFrame: 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
measure: Duration of Response
timeFrame: 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
measure: Duration of Stable Disease (SD)
timeFrame: 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
Other outcomes:
measure: Objective Tumor Response (Update)
timeFrame: From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks
measure: Tumor Response (Update)
timeFrame: From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks
measure: Disease Control (Update)
timeFrame: From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks
measure: Overall Survival (Update)
timeFrame: From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011).
measure: Progression-free Survival (Update)
timeFrame: From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks
measure: Time to Progression (Update)
timeFrame: From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks
measure: Duration of Response (Update)
timeFrame: From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks
measure: Duration of Stable Disease (Update)
timeFrame: From start of treatment of the first participant until database cut-off approximately 37 months later (13May2008 - 1Jun2011). Assessed every 8 weeks for 6 months, then every 12 weeks
Locations:
city: Los Angeles
country: United States
state: California
city: Houston
country: United States
state: Texas
city: Helsinki
country: Finland
city: Turku
country: Finland
city: Nantes
country: France
city: Paris
country: France
city: Frankfurt
country: Germany
state: Hessen
city: Dresden
country: Germany
state: Sachsen
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Bialystok
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
city: Leicester
country: United Kingdom
state: Leicestershire
city: Bristol
country: United Kingdom
city: Cambridge
country: United Kingdom
city: London
country: United Kingdom
city: Northwood
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Eisen T, Joensuu H, Nathan PD, Harper PG, Wojtukiewicz MZ, Nicholson S, Bahl A, Tomczak P, Pyrhonen S, Fife K, Bono P, Boxall J, Wagner A, Jeffers M, Lin T, Quinn DI. Regorafenib for patients with previously untreated metastatic or unresectable renal-cell carcinoma: a single-group phase 2 trial. Lancet Oncol. 2012 Oct;13(10):1055-62. doi: 10.1016/S1470-2045(12)70364-9. Epub 2012 Sep 6.