check_circleStudy Completed

Carcinoma, Renal Cell

Bayer Identifier:

11726

ClinicalTrials.gov Identifier:

NCT00664326

EudraCT Number:

2008-000107-28

EU CT Number:

Not Available
A Phase II uncontrolled study of BAY73-4506 in previously untreated patients with metastatic or unresectable RCC

Trial purpose

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).

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
49
Trial Dates
April 2008 - April 2019
Phase
Phase 2
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Frankfurt, 60596, Germany
Completed
Berlin, 10967, Germany
Completed
Dresden, 01307, Germany
Completed
Bristol, BS2 8ED, United Kingdom
Completed
NANTES, 44020, France
Completed
Poznan, 60-569, Poland
Completed
Lublin, 20-090, Poland
Completed
Bialystok, 15-027, Poland
Completed
Helsinki, 00290, Finland
Completed
Turku, FIN-20521, Finland
Completed
Hamburg, 20246, Germany
Completed
Northwood, HA6 2RN, United Kingdom
Completed
Cambridge, CB2 0QQ, United Kingdom
Completed
London, SE1 9RT, United Kingdom
Completed
Leicester, LE1 5WW, United Kingdom
Completed
Los Angeles, 90033, United States
Completed
Houston, 77030, United States
Completed
PARIS, 75014, France

Primary Outcome

  • Objective tumor response
    Objective tumor response of a participant was defined as the best tumor response (confirmed Complete Response [CR, tumor disappears] or Partial Response [PR, sum of lesion sizes decreased at least 30% from baseline]) observed during trial period assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) committee.
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • Tumor response
    Tumor response of a participant was defined as the best tumor response (confirmed Complete Response [CR, tumor disappears], Partial Response [PR, sum of lesion sizes decreased at least 30% from baseline], Stable Disease [SD, steady state of disease], or Progressive Disease [PD, sum of lesion sizes increased at least 20% from smallest sum on study or new lesions]) observed during trial period assessed according to the RECIST committee.
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Disease control
    Disease control was defined as the percentage of participants who had a best response rating of CR (tumor disappears), PR (sum of lesion sizes decreased at least 30% from baseline), or SD (steady state of disease) that was maintained for at least 28 days from the first demonstration of that rating.
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • Overall survival
    Overall survival (OS) was calculated as the time from the first date of receiving study medication to death, due to any cause. Participants alive at the time of analysis were censored at their last date of follow-up.
    date_rangeTime Frame:
    From start of treatment of the first participant until database cut-off approximately 13 months later (13May2008 - 31May2009).
    enhanced_encryption
    Safety Issue:
    No
  • Progression-free survival (PFS)
    PFS was calculated as time from first date of receiving study drug until date of first observed disease progression (PD) (radiological or clinical, whichever was earlier) or death due to any cause, if death occurred before PD was documented. The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD or death at time of analysis were censored at last date of tumor evaluation.
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • Time to progression (TTP)
    TTP was calculated as time from first date of receiving study drug until date of first documented disease progression (PD) (radiological or clinical, whichever was earlier). The actual date of tumor assessments (i.e., date on which radiological procedure was performed, rather than the scheduled date) was used for this calculation to determine both the event date and censoring date. Patients without PD at time of analysis were censored at last date of tumor evaluation.
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • Duration of response
    Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was earlier, to disease progression or death (if death occurred before progression was documented). Duration of response for subjects who had not progressed or died at the time of analysis were censored at the date of their last tumor assessment.
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No
  • Duration of stable disease (SD)
    Duration of SD was calculated as the time from the first date of receiving study drug until the date of documented PD or the last observation if the subject did not progress. Subjects without disease progression at the time of analysis were censored at the last date of tumor evaluation.
    date_rangeTime 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
    enhanced_encryption
    Safety Issue:
    No

Trial design

A Phase II uncontrolled study of BAY73-4506 in previously untreated patients with metastatic or unresectable renal cell cancer (RCC)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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