Study of Regorafenib After Sorafenib in Patients With Hepatocellular Carcinoma (RESORCE)
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ClinicalTrials.gov Identifier: NCT01774344 |
Recruitment Status :
Completed
First Posted : January 24, 2013
Results First Posted : June 5, 2017
Last Update Posted : August 20, 2020
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Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
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Study Type | Interventional |
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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 (Stivarga, BAY73-4506) Drug: Placebo |
Enrollment | 573 |
Participant Flow
Recruitment Details | The study was conducted between 14 May 2013 (first subject first visit), 29 February 2016 (primary completion date) and 05-July-2019 (Last Patient Last Visit =End of study). |
Pre-assignment Details | Overall, 843 subjects were screened, of them 270 subjects were screening failures. 573 subjects were randomized and assigned to treatment; of them 6 subjects never received treatment. 436 Entered survival Follow-up and 4 End of survival follow-up data not available. |
Arm/Group Title | Placebo | Regorafenib 160 mg (BAY73-4506) |
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Arm/Group Description | 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. | 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. |
Period Title: Overall Study | ||
Started | 194 | 379 |
Treated | 193 | 374 |
Entered Survival FU | 145 | 291 |
Completed | 132 | 258 |
Not Completed | 62 | 121 |
Reason Not Completed | ||
Withdrawal by Subject | 3 | 10 |
Protocol Violation | 0 | 1 |
Lost to Follow-up | 4 | 10 |
End of survival follow-up not available | 2 | 2 |
Data collection finished | 4 | 14 |
Other | 0 | 1 |
Did not enter Survival Follow up | 49 | 83 |
Baseline Characteristics
Arm/Group Title | Placebo | Regorafenib 160 mg (BAY73-4506) | Total | |
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Arm/Group Description | Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best supportive care (BSC). | 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 of all reporting groups | |
Overall Number of Baseline Participants | 194 | 379 | 573 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 194 participants | 379 participants | 573 participants | |
61.1 (11.6) | 61.8 (12.4) | 61.6 (12.1) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 194 participants | 379 participants | 573 participants | |
Female |
23 11.9%
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46 12.1%
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69 12.0%
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Male |
171 88.1%
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333 87.9%
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504 88.0%
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Eastern cooperative oncology group (ECOG) Performance Status (PS) (data collection system-RAVE)
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 194 participants | 379 participants | 573 participants | |
ECOG PS 0 |
130 67.0%
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247 65.2%
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377 65.8%
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ECOG PS 1 |
64 33.0%
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132 34.8%
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196 34.2%
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[1]
Measure Description: ECOG PS was measured in a scale from 0 (best) to grade 4 (worst), where 0= Fully active, able to carry on all pre-diseases performance without restriction, 1= Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2= Ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50 percent (%) waking hours (h), 3= Capable of only limited self-care, confined to bed/chair, more than 50% waking hours, and 4= Completely disabled, cannot carry on any self-care, totally confined to bed/chair.
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ECOG PS: Interactive voice response system (IVRS)
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 194 participants | 379 participants | 573 participants | |
ECOG PS 0 |
129 66.5%
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251 66.2%
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380 66.3%
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ECOG PS 1 |
65 33.5%
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128 33.8%
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193 33.7%
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[1]
Measure Description: ECOG PS was measured in a scale from 0 (best) to grade 4 (worst), where 0= Fully active, able to carry on all pre-diseases performance without restriction, 1= Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, 2= Ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50 % waking h, 3= Capable of only limited self-care, confined to bed/chair, more than 50% waking hours, and 4= Completely disabled, cannot carry on any self-care, totally confined to bed/chair.
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Alpha-fetoprotein (AFP) (RAVE)
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 194 participants | 379 participants | 573 participants | |
less than (<) 400 nanogram per milliliter (ng/mL) |
107 55.2%
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217 57.3%
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324 56.5%
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greater than or equal to (>=) 400 ng/mL |
87 44.8%
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162 42.7%
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249 43.5%
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[1]
Measure Description: Alpha-Fetoprotein blood test was performed and baseline data were reported.
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Alpha-fetoprotein (AFP) (IVRS)
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 194 participants | 379 participants | 573 participants | |
< 400 ng/mL |
105 54.1%
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212 55.9%
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317 55.3%
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>= 400 ng/mL |
89 45.9%
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167 44.1%
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256 44.7%
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[1]
Measure Description: AFP blood test was performed and baseline data were reported.
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Macrovascular invasion (RAVE)
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 194 participants | 379 participants | 573 participants | |
Absence |
140 72.2%
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269 71.0%
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409 71.4%
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Presence |
54 27.8%
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110 29.0%
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164 28.6%
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[1]
Measure Description: Macrovascular invasion was defined as presence or absence of invasion of portal or hepatic vasculature by tumor.
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Macrovascular invasion (IVRS)
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 194 participants | 379 participants | 573 participants | |
Absence |
135 69.6%
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262 69.1%
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397 69.3%
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Presence |
59 30.4%
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117 30.9%
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176 30.7%
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[1]
Measure Description: Macrovascular invasion was defined as presence or absence of invasion of portal or hepatic vasculature by tumor.
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The Barcelona-Clinic Liver Cancer (BCLC) stage at study entry
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 194 participants | 379 participants | 573 participants | |
Early stage |
0 0.0%
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1 0.3%
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1 0.2%
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Intermediate stage |
22 11.3%
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53 14.0%
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75 13.1%
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Advanced stage |
172 88.7%
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325 85.8%
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497 86.7%
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[1]
Measure Description: BCLC classification divides HCC subjects in 5 stages (0=very early stage, A=early stage, B=intermediate stage, C=advanced stage and D=terminal stage) according to pre-established prognostic variables, and allocates therapies according to treatment-related status. Thus, it provides information on both prognostic prediction and treatment allocation.
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Extrahepatic disease (RAVE)
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 194 participants | 379 participants | 573 participants | |
Absence |
47 24.2%
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114 30.1%
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161 28.1%
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Presence |
147 75.8%
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265 69.9%
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412 71.9%
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[1]
Measure Description: Extrahepatic disease defined as presence or absence of tumor outside the liver.
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Extrahepatic disease (IVRS)
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 194 participants | 379 participants | 573 participants | |
Absence |
62 32.0%
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129 34.0%
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191 33.3%
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Presence |
132 68.0%
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250 66.0%
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382 66.7%
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[1]
Measure Description: Extrahepatic disease defined as presence or absence of tumor outside the liver.
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Outcome Measures
Adverse Events
Limitations and Caveats
Decimal places were automatically truncated if last decimal equals zero.
More Information
Results Point of Contact
Name/Title: | Therapeutic Area Head |
Organization: | Bayer AG |
EMail: | clinical-trials-contact@bayer.com |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT01774344 |
Other Study ID Numbers: |
15982 2012-003649-14 ( EudraCT Number ) |
First Submitted: | January 21, 2013 |
First Posted: | January 24, 2013 |
Results First Submitted: | February 9, 2017 |
Results First Posted: | June 5, 2017 |
Last Update Posted: | August 20, 2020 |