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Study to Determine the Safety, Maximum Tolerated Dose, Pharmacokinetics of Sorafenib (BAY43-9006)

This study has been completed.
Sponsor:
Collaborator:
Onyx Pharmaceuticals
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00941863
First received: June 12, 2009
Last updated: February 24, 2016
Last verified: February 2016
Results First Received: February 3, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Carcinoma
Interventions: Drug: Sorafenib 100 mg (50-mg tablet)
Drug: Sorafenib 200 mg (50-mg tablet)
Drug: Sorafenib 400 mg (50-mg tablet)
Drug: Sorafenib 400 mg (200-mg tablet)
Drug: Sorafenib 400 mg (Expansion)

  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
The study was conducted at 3 centers in the US: the University of Wisconsin, the University of Pennsylvania, and Vanderbilt University. Enrollment began 01 Jul 2002.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Expansion in this context is an increase in the number of patients exposed to the recommended dose for this combination. The purpose of the increase was also to test efficacy signals in Metastatic Melanoma (MM).

Reporting Groups
  Description
Sorafenib 100 mg (50-mg Tablet) Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
Sorafenib 200 mg (50-mg Tablet) Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
Sorafenib 400 mg (50-mg Tablet) Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
Sorafenib 400 mg (200-mg Tablet) Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
Sorafenib 400 mg (Expansion) Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion

Participant Flow for 2 periods

Period 1:   Until Primary Completion Date (PCD)
    Sorafenib 100 mg (50-mg Tablet)     Sorafenib 200 mg (50-mg Tablet)     Sorafenib 400 mg (50-mg Tablet)     Sorafenib 400 mg (200-mg Tablet)     Sorafenib 400 mg (Expansion)  
STARTED     7     3     12     17     119  
Maximum Tolerated Dose     7     3     12     17     94  
COMPLETED     0     0     0     0     25  
NOT COMPLETED     7     3     12     17     94  
Adverse Event                 1                 2                 2                 1                 5  
Physician Decision                 0                 0                 0                 0                 1  
Withdrawal by Subject                 0                 0                 1                 0                 8  
Death                 0                 0                 1                 2                 7  
Disease progression                 6                 1                 8                 14                 73  

Period 2:   Continued After PCD
    Sorafenib 100 mg (50-mg Tablet)     Sorafenib 200 mg (50-mg Tablet)     Sorafenib 400 mg (50-mg Tablet)     Sorafenib 400 mg (200-mg Tablet)     Sorafenib 400 mg (Expansion)  
STARTED     0     0     0     0     25 [1]
COMPLETED     0     0     0     0     6  
NOT COMPLETED     0     0     0     0     19  
Withdrawal by Subject                 0                 0                 0                 0                 1  
Disease progression, recurrence, relapse                 0                 0                 0                 0                 18  
[1] 25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005.



  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 100 mg (50-mg Tablet) Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
Sorafenib 200 mg (50-mg Tablet) Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
Sorafenib 400 mg (50-mg Tablet) Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
Sorafenib 400 mg (200-mg Tablet) Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
Sorafenib 400 mg (Expansion) Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
Total Total of all reporting groups

Baseline Measures
    Sorafenib 100 mg (50-mg Tablet)     Sorafenib 200 mg (50-mg Tablet)     Sorafenib 400 mg (50-mg Tablet)     Sorafenib 400 mg (200-mg Tablet)     Sorafenib 400 mg (Expansion)     Total  
Number of Participants  
[units: participants]
  7     3     12     17     119     158  
Age  
[units: years]
Mean (Standard Deviation)
  49.3  (17.9)     52.0  (12.0)     52.0  (14.4)     52.8  (10.5)     52.8  (12.6)     52.5  (12.6)  
Gender  
[units: participants]
           
Female     2     1     3     7     54     67  
Male     5     2     9     10     65     91  
Race/Ethnicity, Customized  
[units: participants]
           
white     6     3     12     16     113     150  
black     0     0     0     0     2     2  
asian     0     0     0     1     2     3  
hispanic     1     0     0     0     2     3  
Site of primary lesion [1]
[units: participants]
           
Colon     1     0     1     2     1     5  
Malignant Melanoma     3     1     10     10     81     105  
Non Small Cell Lung     1     0     1     2     11     15  
Ovarian     0     0     0     0     3     3  
Renal     0     1     0     1     21     23  
Other     2     1     0     2     2     7  
[1] Tumor response was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) criteria.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Tolerated Dose (MTD) of Sorafenib in Combination With Paclitaxel and Carboplatin   [ Time Frame: 21 days ]

2.  Primary:   Participants With Hematological and Biochemical Toxicities   [ Time Frame: Start of treatment until death or within 14 days last study drug intake ]

3.  Secondary:   Tumor Response   [ Time Frame: From start of treatment until progression or death occurs assessed every 6 weeks. ]

4.  Secondary:   Area Under the Curve From Time 0 to 12 Hours Post-dose (AUC 0-12) Start From Day 2 of Cycle 1   [ Time Frame: At day 2 in study ]

5.  Secondary:   Maximum Concentration (CMAX) Start From Day 2 of Cycle 1   [ Time Frame: At day 2 in study ]

6.  Secondary:   Time of Maximum Concentration (TMAX) Start From Day 2 of Cycle 1   [ Time Frame: At day 2 in study ]

7.  Other Pre-specified:   Serious Adverse Events   [ Time Frame: From start of treatment until 18 Sep 2008, up to 6 years ]

8.  Other Pre-specified:   Other Adverse Events   [ Time Frame: From start of treatment until 18 Sep 2008, up to 6 years ]


  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
No text entered.


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


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



Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00941863     History of Changes
Other Study ID Numbers: 100375
Study First Received: June 12, 2009
Results First Received: February 3, 2010
Last Updated: February 24, 2016
Health Authority: United States: Food and Drug Administration