Phase III Study of Sorafenib in Patients With Renal Cell Carcinoma (RCC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00586105
First received: December 21, 2007
Last updated: March 25, 2014
Last verified: March 2014
Results First Received: February 1, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma, Renal Cell
Intervention: Drug: Sorafenib (Nexavar, BAY43-9006)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were outpatients with histologically or cytologically confirmed, unresectable and/or metastatic, measurable clear Renal Cell Carcinoma (RCC) who had received not more than one prior systemic therapy. They were enrolled between 29 Dec 2005 and 29 Sep 2006 at 4 centers in China and 4 in Taiwan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 51 Asian subjects were enrolled in the trial. Twelve failed screening (11 protocol violations, 1 adverse event); the remaining 39 received at least 1 dose of study drug.

Reporting Groups
  Description
Sorafenib (Nexavar, BAY43-9006) 400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)

Participant Flow:   Overall Study
    Sorafenib (Nexavar, BAY43-9006)  
STARTED     39  
COMPLETED     0  
NOT COMPLETED     39  
Adverse Event                 4  
Death                 2  
Protocol Violation                 1  
Withdrawal by Subject                 3  
Disease progression                 19  
Switched to commercial drug                 9  
Reason not reported                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sorafenib (Nexavar, BAY43-9006) 400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)

Baseline Measures
    Sorafenib (Nexavar, BAY43-9006)  
Number of Participants  
[units: participants]
  39  
Age  
[units: years]
Mean ± Standard Deviation
  58  ± 14.5  
Gender  
[units: participants]
 
Female     9  
Male     30  
Region of Enrollment  
[units: participants]
 
Taiwan     19  
China     20  
Eastern Cooperative Oncology Group (ECOG) Scale [1]
[units: participants]
 
ECOG 0     20  
ECOG 1     19  
Motzer risk factors [2]
[units: participants]
 
Low-risk (no risk factors)     21  
Intermediate-risk (1 or 2 risk factors)     18  
Renal Cell Carcinoma subtype [3]
[units: participants]
 
Clear cell     34  
Predominantly clear cell     5  
Time since first progression [4]
[units: years]
Mean ± Standard Deviation
  0.4  ± 0.6  
Time since initial diagnosis [5]
[units: years]
Mean ± Standard Deviation
  1.7  ± 2.5  
[1] Eastern Cooperative Oncology Group (ECOG) Performance Status is a scale that measures how cancer affects a patient. The scale ranges from 0 (fully active) to 5 (dead). Subjects entering this study must have had an ECOG score of 0 or 1 (restricted in physically strenuous activity but ambulatory).
[2] The 5 Motzer risk factors correlate with overall survival in metastatic RCC. Patients with no factors (low-risk) have a favorable survival risk, patients with 1 or 2 risk factors survive a shorter time and constitute an intermediate-risk group, and those with 3 or more risk factors have the poorest survival and represent a poor-risk group.
[3] Patients were categorized into 1 or 2 subgroups depending on the tumor histology: Clear cell or predominantly clear cell.
[4] Time since first progression was defined as the time from the first progression of the patient’s disease after initial diagnosis until randomization into this study.
[5] Time since initial diagnosis was the mean time from initial diagnosis to randomization into the study.



  Outcome Measures
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1.  Primary:   Pharmacokinetics Measured as Area Under Curve (AUC[0-12h])   [ Time Frame: 12 hours after at least 21 days of uninterrupted dosing ]

2.  Primary:   Pharmacokinetics Measured as Concentration (Cmax at Tmax and Cmin at Tmin)   [ Time Frame: 12 hours after at least 21 days of uninterrupted dosing ]

3.  Primary:   Pharmacokinetics Measured as Concentration (Cmax Normalized at Tmax and Cmin Normalized at Tmin)   [ Time Frame: 12 hours after at least 21 days of uninterrupted dosing ]

4.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: Number of days from date of first dose of study drug to date first observed disease progression or death (whichever was earlier) was documented up to 17.25 months ]

5.  Secondary:   Overall Survival (OS)   [ Time Frame: Time from start of therapy to death up to 17.25 months ]

6.  Secondary:   Time to Progression (TTP)   [ Time Frame: Time from start of study medication to clinical or radiological disease progression which ever occurs first up to 17.25 months ]

7.  Secondary:   Disease Control (DC)   [ Time Frame: From start to end of study medication up to 17.25 months ]

8.  Secondary:   Overall Best Response   [ Time Frame: Best response observed from start to end of study medication up to 17.25 months ]

9.  Secondary:   Overall Response Duration   [ Time Frame: From PR or CR to progression or death up to 17.25 months ]

10.  Secondary:   Time to Objective Response   [ Time Frame: Time from start of study medication to first documented PR or CR up to 17.25 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The median for ´Overall Survival (OS)´ and the median for ´Overall Response Duration´ reported are the median of each distribution including the censored data. The correct estimates of these medians were not evaluable.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Therapeutic Area Head
Organization: BAYER
e-mail: clinical-trials-contact@bayerhealthcare.com


No publications provided


Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00586105     History of Changes
Other Study ID Numbers: 11559
Study First Received: December 21, 2007
Results First Received: February 1, 2010
Last Updated: March 25, 2014
Health Authority: China: Ministry of Health
Taiwan: Department of Health