This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 1 of 1 for:    bayer 15982
Previous Study | Return to List | Next Study

Study of Regorafenib After Sorafenib in Patients With Hepatocellular Carcinoma (RESORCE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01774344
First received: January 21, 2013
Last updated: July 9, 2017
Last verified: July 2017
Results First Received: February 9, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Carcinoma, Hepatocellular
Interventions: Drug: Regorafenib (BAY73-4506)
Drug: Placebo

  Participant Flow
  Hide Participant Flow

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 multiple centers in North America, South America, Europe, Asia, and Australia between 14 May 2013 (first subject first visit) and 29 February 2016 (primary completion date).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Overall, 843 subjects were screened, of them 270 were screen failures. The remaining 573 subjects were randomized and assigned to treatment; of them 6 subjects never received treatment.

Reporting Groups
  Description
Placebo Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
Regorafenib 160 mg (BAY73-4506) Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.

Participant Flow:   Overall Study
    Placebo   Regorafenib 160 mg (BAY73-4506)
STARTED   194   379 
Treated   193   374 
COMPLETED   162   231 
NOT COMPLETED   32   148 
Protocol Violation                3                1 
Withdrawal by Subject                5                26 
Study drug never administered                1                5 
Unspecified                1                0 
Ongoing with treatment                10                65 
AE not related to disease progression                12                47 
Adverse event (AE)                0                1 
Physician Decision                0                1 
Non-compliance with study drug                0                2 



  Baseline Characteristics
  Hide Baseline Characteristics

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
Placebo Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
Regorafenib 160 mg (BAY73-4506) Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
Total Total of all reporting groups

Baseline Measures
   Placebo   Regorafenib 160 mg (BAY73-4506)   Total 
Overall Participants Analyzed 
[Units: Participants]
 194   379   573 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.1  (11.6)   61.8  (12.4)   61.6  (12.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      23  11.9%      46  12.1%      69  12.0% 
Male      171  88.1%      333  87.9%      504  88.0% 
Eastern cooperative oncology group (ECOG) Performance Status (PS) (data collection system-RAVE) [1] 
[Units: Subjects]
     
Grade 0   130   247   377 
Grade 1   64   132   196 
[1] ECOG PS is a standard criteria for measuring how the disease impacts a cancer patient’s daily living abilities in a scale of 0 to 4. Grade 0=Fully active, able to carry on all pre-diseases performance. Grade 1=Restricted in physically strenuous activity but ambulatory and able to carry out light or sedentary work. Grade 2=Ambulatory and capable of all self-care but unable to carry out any work activities. Grade 3=Capable of only limited self-care, confined to bed/chair more than 50% of waking hours. Grade 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed/chair.
ECOG PS: Interactive voice response system (IVRS) [1] 
[Units: Subjects]
     
Grade 0   129   251   380 
Grade 1   65   128   193 
[1] ECOG PS is a standard criteria for measuring how the disease impacts a cancer patient’s daily living abilities in a scale of 0 to 4. Grade 0=Fully active, able to carry on all pre-diseases performance. Grade 1=Restricted in physically strenuous activity but ambulatory and able to carry out light or sedentary work. Grade 2=Ambulatory and capable of all self-care but unable to carry out any work activities. Grade 3=Capable of only limited self-care, confined to bed/chair more than 50% of waking hours. Grade 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed/chair.
Alpha-fetoprotein (AFP) (RAVE) 
[Units: Subjects]
     
less than (<) 400 nanogram per milliliter (ng/mL)   107   217   324 
greater than or equal to (>=) 400 ng/mL   87   162   249 
Alpha-fetoprotein (AFP) (IVRS) 
[Units: Subjects]
     
< 400 ng/mL   105   212   317 
>= 400 ng/mL   89   167   256 
Macrovascular invasion (RAVE) 
[Units: Subjects]
     
Absence   140   269   409 
Presence   54   110   164 
Macrovascular invasion (IVRS) 
[Units: Subjects]
     
Absence   135   262   397 
Presence   59   117   176 
The Barcelona-Clinic Liver Cancer (BCLC) stage at study entry 
[Units: Subjects]
     
Early stage   0   1   1 
Intermediate stage   22   53   75 
Advanced stage   172   325   497 
Extrahepatic disease (RAVE) 
[Units: Subjects]
     
Absence   47   114   161 
Presence   147   265   412 
Extrahepatic disease (IVRS) 
[Units: Subjects]
     
Absence   62   129   191 
Presence   132   250   382 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival (OS)   [ Time Frame: From randomization (Day 1) of the first subject until 419 days later ]

2.  Secondary:   Time to Progression (TTP)   [ Time Frame: From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) (approximately 33 months) ]

3.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) ]

4.  Secondary:   Objective Tumor Response Rate (ORR)   [ Time Frame: From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) (approximately 33 months) ]

5.  Secondary:   Disease Control Rate (DCR)   [ Time Frame: From date of randomization until 30 days after last study treatment (assessed every 6 weeks until PD; and after 8 cycle assessed every 12 weeks) (approximately 33 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
Decimal places were automatically truncated if last decimal equals zero.


  More Information
  Hide More Information

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@bayer.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01774344     History of Changes
Other Study ID Numbers: 15982
2012-003649-14 ( EudraCT Number )
Study First Received: January 21, 2013
Results First Received: February 9, 2017
Last Updated: July 9, 2017