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A Phase 2 Study of Cabozantinib in Japanese Participants With Advanced Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT03586973
Recruitment Status : Completed
First Posted : July 16, 2018
Results First Posted : April 18, 2023
Last Update Posted : April 18, 2023
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Advanced Hepatocellular Carcinoma
Intervention Drug: Cabozantinib
Enrollment 34
Recruitment Details Participants took part in the study at 15 investigative sites in Japan from 06 August 2018 to 29 June 2021.
Pre-assignment Details Participants with a diagnosis of advanced hepatocellular carcinoma (HCC) were enrolled in this study in two Cohorts A and B. Participants who received prior sorafenib were enrolled in Cohort A and participants who received prior systemic anticancer therapy other than sorafenib were enrolled in Cohort B.
Arm/Group Title Cohort A: Cabozantinib 60 mg Cohort B: Cabozantinib 60 mg
Hide Arm/Group Description Participants who have received first/second line anticancer therapy with sorafenib were assigned to Cohort A and received cabozantinib 60 milligrams (mg), tablet, orally, once daily in the fasted state, up to approximately 2 years. Participants who did not receive first/second line anticancer therapy with sorafenib were assigned to Cohort B and received cabozantinib 60 mg, tablet orally, once daily in the fasted state, up to approximately 2 years.
Period Title: Overall Study
Started 20 14
Completed 0 0
Not Completed 20 14
Reason Not Completed
Death             15             8
Site Terminated by Sponsor             3             6
Withdrawal by Subject             1             0
Lost to Follow-up             1             0
Arm/Group Title Cohort A: Cabozantinib 60 mg Cohort B: Cabozantinib 60 mg Total
Hide Arm/Group Description Participants who have received first/second line anticancer therapy with sorafenib were assigned to Cohort A and received cabozantinib 60 milligrams (mg), tablet, orally, once daily in the fasted state, up to approximately 2 years. Participants who did not receive first/second line anticancer therapy with sorafenib were assigned to Cohort B and received cabozantinib 60 mg, tablet orally, once daily in the fasted state, up to approximately 2 years. Total of all reporting groups
Overall Number of Baseline Participants 20 14 34
Hide Baseline Analysis Population Description
Full Analysis Set (FAS) included participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 14 participants 34 participants
72.2  (6.32) 71.6  (8.13) 72  (7.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 14 participants 34 participants
Female
3
  15.0%
0
   0.0%
3
   8.8%
Male
17
  85.0%
14
 100.0%
31
  91.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Asian Number Analyzed 20 participants 14 participants 34 participants
20
 100.0%
14
 100.0%
34
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Not Hispanic or Latino Number Analyzed 20 participants 14 participants 34 participants
20
 100.0%
14
 100.0%
34
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Japan Number Analyzed 20 participants 14 participants 34 participants
20
 100.0%
14
 100.0%
34
 100.0%
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter (cm)
Number Analyzed 20 participants 14 participants 34 participants
162.2  (8.31) 165.4  (7.08) 163.5  (7.88)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 20 participants 14 participants 34 participants
61.60  (9.123) 64.54  (11.351) 62.81  (10.042)
Body Mass Index (BMI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter (kg/m^2)
Number Analyzed 20 participants 14 participants 34 participants
23.34  (2.262) 23.46  (2.894) 23.39  (2.5)
[1]
Measure Description: Body Mass Index=weight (kg)/[height (m)^2]
History of Drinking Alcohol   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 20 participants 14 participants 34 participants
Current Drinker
6
  30.0%
5
  35.7%
11
  32.4%
Former Drinker
10
  50.0%
9
  64.3%
19
  55.9%
Never Drunk
4
  20.0%
0
   0.0%
4
  11.8%
[1]
Measure Description: Participants were divided as per the history of drinking alcohol.
Current Etiology of Disease   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 20 participants 14 participants 34 participants
Hepatitis B (Without Hepatitis C)
5
  25.0%
1
   7.1%
6
  17.6%
Hepatitis C (Without Hepatitis B)
7
  35.0%
3
  21.4%
10
  29.4%
Hepatitis B and C
0
   0.0%
1
   7.1%
1
   2.9%
Hepatitis B (Regardless of Hepatitis C)
5
  25.0%
2
  14.3%
7
  20.6%
Hepatitis C (Regardless of Hepatitis B)
7
  35.0%
4
  28.6%
11
  32.4%
Without Hepatitis B and C
8
  40.0%
9
  64.3%
17
  50.0%
Alcoholism
5
  25.0%
5
  35.7%
10
  29.4%
Nonalcoholic Steatohepatitis (NASH)
1
   5.0%
2
  14.3%
3
   8.8%
Other
3
  15.0%
2
  14.3%
5
  14.7%
[1]
Measure Description: Participants were divided as per the etiology of disease at baseline. Participants were counted more than once in multiple categories. The current etiology (cause of disease or condition) is reported in categories as: 1) Hepatitis B (Without Hepatitis C), 2) Hepatitis C (Without Hepatitis B), 3) Hepatitis B and C, 4) Hepatitis B (Regardless of Hepatitis C), 5) Hepatitis C (Regardless of Hepatitis B), 6) Without Hepatitis B and C, 7) Alcoholism, 8) Nonalcoholic Steatohepatitis (NASH), 8) Other
Child-Pugh Score: Grade A   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 14 participants 34 participants
20
 100.0%
14
 100.0%
34
 100.0%
[1]
Measure Description: Child-Pugh score was graded as A to C based on total score from Points assigned, where A- well-compensated disease; B- significant functional compromise; C-decompensated disease. Data is reported for those categories with at least one participant.
Extrahepatic Spread and/or Macrovascular Invasion  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 20 participants 14 participants 34 participants
Presence
7
  35.0%
6
  42.9%
13
  38.2%
No presence
13
  65.0%
8
  57.1%
21
  61.8%
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): Grade 1   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 14 participants 34 participants
0
   0.0%
3
  21.4%
3
   8.8%
[1]
Measure Description: The ECOG scale was as follows: Grade 0: Fully active, able to perform all pre-disease activities without restriction; Grade 1: Restricted in physically strenuous activity, ambulatory, able to carry out light work; Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair > 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Only categories with participants are reported.
1.Primary Outcome
Title 24-Week Progression-Free Survival Rate (PFSR)
Hide Description 24-week PFSR=percentage of participants with progression-free survival (PFS) of at least 24 weeks at Week 25 Day 1 plus 7 days. PFS=time from first day of study drug administration to earlier of progressive disease (PD) or death due to any cause per Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST 1.1). PD=at least a 20% increase in sum of target lesion diameters (SoD) with reference to smallest(nadir) SoD. In addition to relative increase of 20%, SoD must also demonstrate an absolute increase of at least 5 mm. For nontarget lesion time Point Response, unequivocal progression of nontarget lesions. Modest 'increase' in size of one or more nontarget lesions is usually not sufficient to quality for unequivocal progression status, it must not be representative of single lesion increase. Lesion in an anatomical location and not scanned at baseline is considered new lesion. Lesion qualifies as PD if finding is unequivocally not due to change in imaging technique or modality.
Time Frame Week 25 Day 1 plus 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) included participants who received at least one dose of study drug.
Arm/Group Title Cohort A: Cabozantinib 60 mg Cohort B: Cabozantinib 60 mg
Hide Arm/Group Description:
Participants who have received first/second line anticancer therapy with sorafenib were assigned to Cohort A and received cabozantinib 60 milligrams (mg), tablet, orally, once daily in the fasted state, up to approximately 2 years.
Participants who did not receive first/second line anticancer therapy with sorafenib were assigned to Cohort B and received cabozantinib 60 mg, tablet orally, once daily in the fasted state, up to approximately 2 years.
Overall Number of Participants Analyzed 20 14
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
59.8
(36.06 to 77.21)
16.7
(4.02 to 36.82)
2.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS was defined as time from the first day of study drug administration to the earlier of PD per RECIST 1.1 as assessed by IRC or death due to any cause. Per RECIST 1.1, for target lesion time point response, PD was defined at least a 20% increase in the SoD of target lesions, taking as a reference the smallest (nadir) SoD since (and including) baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. For nontarget lesion time point response, unequivocal progression of nontarget lesions. A modest 'increase' in the size of one or more nontarget lesions is usually not sufficient to quality for unequivocal progression status. It must be representative of overall disease status change, not a single lesion increase. The lesion qualifies as a PD if the finding is unequivocally not due to a change in the imaging technique or modality.
Time Frame Until disease progression, or death or end of study (Up to approximately 2.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who received at least one dose of study drug.
Arm/Group Title Cohort A: Cabozantinib 60 mg Cohort B: Cabozantinib 60 mg
Hide Arm/Group Description:
Participants who have received first/second line anticancer therapy with sorafenib were assigned to Cohort A and received cabozantinib 60 milligrams (mg), tablet, orally, once daily in the fasted state, up to approximately 2 years.
Participants who did not receive first/second line anticancer therapy with sorafenib were assigned to Cohort B and received cabozantinib 60 mg, tablet orally, once daily in the fasted state, up to approximately 2 years.
Overall Number of Participants Analyzed 20 14
Median (95% Confidence Interval)
Unit of Measure: months
7.4
(5.5 to 9.5)
3.6
(1.8 to 5.6)
3.Secondary Outcome
Title Objective Response Rate (ORR)
Hide Description ORR was defined as the percentage of participants whose best overall response was complete response (CR) or partial response (PR) per RECIST 1.1 as assessed by IRC, which was confirmed by a subsequent evaluation conducted >= 28 days later. Per RECIST 1.1, for target lesion time point response, CR was defined disappearance of all target lesions. All pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 mm. For nontarget lesion time point response, disappearance of all nontarget lesions. All lymph nodes must be nonpathological in size (<10 mm short axis); PR was defined as at least a 30% decrease in SoD of target lesions, taking as a reference the baseline SoD.
Time Frame Up to approximately 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who received at least one dose of study drug.
Arm/Group Title Cohort A: Cabozantinib 60 mg Cohort B: Cabozantinib 60 mg
Hide Arm/Group Description:
Participants who have received first/second line anticancer therapy with sorafenib were assigned to Cohort A and received cabozantinib 60 milligrams (mg), tablet, orally, once daily in the fasted state, up to approximately 2 years.
Participants who did not receive first/second line anticancer therapy with sorafenib were assigned to Cohort B and received cabozantinib 60 mg, tablet orally, once daily in the fasted state, up to approximately 2 years.
Overall Number of Participants Analyzed 20 14
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5.0
(0.127 to 24.873)
0.0
(0.000 to 23.164)
4.Secondary Outcome
Title Disease Control Rate (DCR)
Hide Description DCR=percentage of participants whose best overall response is CR,PR or SD, per RECIST 1.1, CR and PR require confirmation by subsequent evaluation conducted >=28 days later, and SD have to be maintained for at least 8 weeks after first day of study drug administration. CR=disappearance of all target lesions. All pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 mm. For nontarget lesion time point response, disappearance of all nontarget lesions. All lymph nodes must be nonpathological in size (<10 mm short axis); PR=at least a 30% decrease in SoD of target lesions, taking as reference baseline SoD; SD=neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; SoD must also demonstrate an absolute increase of at least 5 mm; PD=at least a 20% increase in SoD of target lesions, taking as a reference smallest (nadir) SoD.
Time Frame Up to approximately 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who received at least one dose of study drug.
Arm/Group Title Cohort A: Cabozantinib 60 mg Cohort B: Cabozantinib 60 mg
Hide Arm/Group Description:
Participants who have received first/second line anticancer therapy with sorafenib were assigned to Cohort A and received cabozantinib 60 milligrams (mg), tablet, orally, once daily in the fasted state, up to approximately 2 years.
Participants who did not receive first/second line anticancer therapy with sorafenib were assigned to Cohort B and received cabozantinib 60 mg, tablet orally, once daily in the fasted state, up to approximately 2 years.
Overall Number of Participants Analyzed 20 14
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
85.0
(62.107 to 96.793)
64.3
(35.138 to 87.240)
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as time from the first day of study drug administration to death due to any cause. Participants without documentation of death were censored on the date they were last known to be alive.
Time Frame Up to end of study (Up to approximately 2.8 years)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS included participants who received at least one dose of study drug.
Arm/Group Title Cohort A: Cabozantinib 60 mg Cohort B: Cabozantinib 60 mg
Hide Arm/Group Description:
Participants who have received first/second line anticancer therapy with sorafenib were assigned to Cohort A and received cabozantinib 60 milligrams (mg), tablet, orally, once daily in the fasted state, up to approximately 2 years.
Participants who did not receive first/second line anticancer therapy with sorafenib were assigned to Cohort B and received cabozantinib 60 mg, tablet orally, once daily in the fasted state, up to approximately 2 years.
Overall Number of Participants Analyzed 20 14
Median (95% Confidence Interval)
Unit of Measure: months
19.3
(13.3 to 22.6)
9.9 [1] 
(3.6 to NA)
[1]
Upper limit of 95% confidence interval was not estimable due to lower number of participants with the event.
Time Frame All-Cause Mortality: Up to end of study (Up to approximately 2.8 years); Serious and other adverse events: From first dose up to 30 days post last dose (Up to approximately 2 years)
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Cohort A: Cabozantinib 60 mg Cohort B: Cabozantinib 60 mg
Hide Arm/Group Description Participants who have received first/second line anticancer therapy with sorafenib were assigned to Cohort A and received cabozantinib 60 milligrams (mg), tablet, orally, once daily in the fasted state, up to approximately 2 years. Participants who did not receive first/second line anticancer therapy with sorafenib were assigned to Cohort B and received cabozantinib 60 mg, tablet orally, once daily in the fasted state, up to approximately 2 years.
All-Cause Mortality
Cohort A: Cabozantinib 60 mg Cohort B: Cabozantinib 60 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   15/20 (75.00%)   8/14 (57.14%) 
Hide Serious Adverse Events
Cohort A: Cabozantinib 60 mg Cohort B: Cabozantinib 60 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   7/20 (35.00%)   2/14 (14.29%) 
Gastrointestinal disorders     
Gastrointestinal ulcer † 1  1/20 (5.00%)  0/14 (0.00%) 
Ileus † 1  1/20 (5.00%)  0/14 (0.00%) 
General disorders     
Pyrexia † 1  0/20 (0.00%)  1/14 (7.14%) 
Hepatobiliary disorders     
Cholangitis † 1  1/20 (5.00%)  1/14 (7.14%) 
Biloma † 1  1/20 (5.00%)  0/14 (0.00%) 
Cholelithiasis † 1  1/20 (5.00%)  0/14 (0.00%) 
Infections and infestations     
Liver abscess † 1  1/20 (5.00%)  0/14 (0.00%) 
Meningitis bacterial † 1  1/20 (5.00%)  0/14 (0.00%) 
Peritonitis bacterial † 1  1/20 (5.00%)  0/14 (0.00%) 
Metabolism and nutrition disorders     
Hypocalcaemia † 1  1/20 (5.00%)  0/14 (0.00%) 
Nervous system disorders     
Hepatic encephalopathy † 1  0/20 (0.00%)  1/14 (7.14%) 
1
Term from vocabulary, MedDRA22.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort A: Cabozantinib 60 mg Cohort B: Cabozantinib 60 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   20/20 (100.00%)   14/14 (100.00%) 
Blood and lymphatic system disorders     
Anaemia † 1  3/20 (15.00%)  2/14 (14.29%) 
Lymphopenia † 1  2/20 (10.00%)  0/14 (0.00%) 
Neutropenia † 1  0/20 (0.00%)  1/14 (7.14%) 
Thrombocytopenia † 1  1/20 (5.00%)  0/14 (0.00%) 
Ear and labyrinth disorders     
Tinnitus † 1  1/20 (5.00%)  0/14 (0.00%) 
Endocrine disorders     
Hypothyroidism † 1  7/20 (35.00%)  3/14 (21.43%) 
Eye disorders     
Dry eye † 1  0/20 (0.00%)  1/14 (7.14%) 
Gastrointestinal disorders     
Diarrhoea † 1  15/20 (75.00%)  6/14 (42.86%) 
Constipation † 1  1/20 (5.00%)  6/14 (42.86%) 
Stomatitis † 1  4/20 (20.00%)  2/14 (14.29%) 
Vomiting † 1  5/20 (25.00%)  1/14 (7.14%) 
Abdominal pain upper † 1  3/20 (15.00%)  1/14 (7.14%) 
Nausea † 1  3/20 (15.00%)  1/14 (7.14%) 
Ascites † 1  2/20 (10.00%)  1/14 (7.14%) 
Periodontal disease † 1  1/20 (5.00%)  2/14 (14.29%) 
Gastrooesophageal reflux disease † 1  2/20 (10.00%)  0/14 (0.00%) 
Abdominal pain † 1  0/20 (0.00%)  1/14 (7.14%) 
Anal erosion † 1  0/20 (0.00%)  1/14 (7.14%) 
Aphthous ulcer † 1  0/20 (0.00%)  1/14 (7.14%) 
Epigastric discomfort † 1  0/20 (0.00%)  1/14 (7.14%) 
Glossodynia † 1  1/20 (5.00%)  0/14 (0.00%) 
Inguinal hernia † 1  1/20 (5.00%)  0/14 (0.00%) 
Oral pain † 1  1/20 (5.00%)  0/14 (0.00%) 
Proctalgia † 1  1/20 (5.00%)  0/14 (0.00%) 
General disorders     
Fatigue † 1  5/20 (25.00%)  3/14 (21.43%) 
Malaise † 1  6/20 (30.00%)  2/14 (14.29%) 
Pyrexia † 1  3/20 (15.00%)  4/14 (28.57%) 
Oedema peripheral † 1  3/20 (15.00%)  1/14 (7.14%) 
Oedema † 1  2/20 (10.00%)  0/14 (0.00%) 
Chest pain † 1  1/20 (5.00%)  0/14 (0.00%) 
Influenza like illness † 1  0/20 (0.00%)  1/14 (7.14%) 
Mass † 1  1/20 (5.00%)  0/14 (0.00%) 
Hepatobiliary disorders     
Hepatic function abnormal † 1  3/20 (15.00%)  2/14 (14.29%) 
Portal vein thrombosis † 1  0/20 (0.00%)  1/14 (7.14%) 
Immune system disorders     
Seasonal allergy † 1  1/20 (5.00%)  0/14 (0.00%) 
Infections and infestations     
Nasopharyngitis † 1  5/20 (25.00%)  1/14 (7.14%) 
Bronchitis † 1  0/20 (0.00%)  1/14 (7.14%) 
Cystitis bacterial † 1  1/20 (5.00%)  0/14 (0.00%) 
Folliculitis † 1  0/20 (0.00%)  1/14 (7.14%) 
Fungal oesophagitis † 1  1/20 (5.00%)  0/14 (0.00%) 
Herpes zoster † 1  0/20 (0.00%)  1/14 (7.14%) 
Influenza † 1  1/20 (5.00%)  0/14 (0.00%) 
Liver abscess † 1  1/20 (5.00%)  0/14 (0.00%) 
Paronychia † 1  1/20 (5.00%)  0/14 (0.00%) 
Periodontitis † 1  1/20 (5.00%)  0/14 (0.00%) 
Purulence † 1  0/20 (0.00%)  1/14 (7.14%) 
Tinea cruris † 1  1/20 (5.00%)  0/14 (0.00%) 
Tinea faciei † 1  0/20 (0.00%)  1/14 (7.14%) 
Tinea infection † 1  1/20 (5.00%)  0/14 (0.00%) 
Upper respiratory tract infection † 1  1/20 (5.00%)  0/14 (0.00%) 
Urethritis † 1  1/20 (5.00%)  0/14 (0.00%) 
Injury, poisoning and procedural complications     
Fall † 1  3/20 (15.00%)  1/14 (7.14%) 
Skin abrasion † 1  2/20 (10.00%)  0/14 (0.00%) 
Rib fracture † 1  1/20 (5.00%)  0/14 (0.00%) 
Skin injury † 1  0/20 (0.00%)  1/14 (7.14%) 
Spinal compression fracture † 1  1/20 (5.00%)  0/14 (0.00%) 
Investigations     
Platelet count decreased † 1  6/20 (30.00%)  7/14 (50.00%) 
Aspartate aminotransferase increased † 1  6/20 (30.00%)  6/14 (42.86%) 
Alanine aminotransferase increased † 1  5/20 (25.00%)  5/14 (35.71%) 
Neutrophil count decreased † 1  5/20 (25.00%)  2/14 (14.29%) 
Blood thyroid stimulating hormone increased † 1  3/20 (15.00%)  3/14 (21.43%) 
Weight decreased † 1  5/20 (25.00%)  1/14 (7.14%) 
Blood lactate dehydrogenase increased † 1  3/20 (15.00%)  2/14 (14.29%) 
Amylase increased † 1  3/20 (15.00%)  1/14 (7.14%) 
Lipase increased † 1  1/20 (5.00%)  2/14 (14.29%) 
White blood cell count decreased † 1  1/20 (5.00%)  2/14 (14.29%) 
Blood alkaline phosphatase increased † 1  2/20 (10.00%)  0/14 (0.00%) 
Blood creatinine increased † 1  1/20 (5.00%)  1/14 (7.14%) 
Blood bilirubin increased † 1  0/20 (0.00%)  1/14 (7.14%) 
Blood urine present † 1  0/20 (0.00%)  1/14 (7.14%) 
Glomerular filtration rate decreased † 1  1/20 (5.00%)  0/14 (0.00%) 
Hepatic enzyme increased † 1  1/20 (5.00%)  0/14 (0.00%) 
Liver function test abnormal † 1  1/20 (5.00%)  0/14 (0.00%) 
Liver function test increased † 1  1/20 (5.00%)  0/14 (0.00%) 
Neutrophil count increased † 1  1/20 (5.00%)  0/14 (0.00%) 
Urine protein/creatinine ratio increased † 1  1/20 (5.00%)  0/14 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite † 1  8/20 (40.00%)  7/14 (50.00%) 
Hyperammonaemia † 1  3/20 (15.00%)  0/14 (0.00%) 
Hypoalbuminaemia † 1  2/20 (10.00%)  0/14 (0.00%) 
Diabetes mellitus † 1  0/20 (0.00%)  1/14 (7.14%) 
Gout † 1  0/20 (0.00%)  1/14 (7.14%) 
Hyperkalaemia † 1  0/20 (0.00%)  1/14 (7.14%) 
Hypocalcaemia † 1  1/20 (5.00%)  0/14 (0.00%) 
Hypokalaemia † 1  1/20 (5.00%)  0/14 (0.00%) 
Hypomagnesaemia † 1  1/20 (5.00%)  0/14 (0.00%) 
Hypophosphataemia † 1  1/20 (5.00%)  0/14 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscle spasms † 1  2/20 (10.00%)  2/14 (14.29%) 
Back pain † 1  1/20 (5.00%)  2/14 (14.29%) 
Arthralgia † 1  1/20 (5.00%)  0/14 (0.00%) 
Musculoskeletal pain † 1  1/20 (5.00%)  0/14 (0.00%) 
Neck pain † 1  1/20 (5.00%)  0/14 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumour pain † 1  1/20 (5.00%)  0/14 (0.00%) 
Nervous system disorders     
Dysgeusia † 1  4/20 (20.00%)  3/14 (21.43%) 
Headache † 1  2/20 (10.00%)  0/14 (0.00%) 
Taste disorder † 1  1/20 (5.00%)  0/14 (0.00%) 
Psychiatric disorders     
Insomnia † 1  2/20 (10.00%)  0/14 (0.00%) 
Renal and urinary disorders     
Proteinuria † 1  3/20 (15.00%)  4/14 (28.57%) 
Acute kidney injury † 1  0/20 (0.00%)  1/14 (7.14%) 
Haemoglobinuria † 1  0/20 (0.00%)  1/14 (7.14%) 
Renal impairment † 1  1/20 (5.00%)  0/14 (0.00%) 
Reproductive system and breast disorders     
Breast mass † 1  1/20 (5.00%)  0/14 (0.00%) 
Gynaecomastia † 1  1/20 (5.00%)  0/14 (0.00%) 
Scrotal oedema † 1  1/20 (5.00%)  0/14 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dysphonia † 1  8/20 (40.00%)  0/14 (0.00%) 
Cough † 1  3/20 (15.00%)  1/14 (7.14%) 
Oropharyngeal pain † 1  1/20 (5.00%)  1/14 (7.14%) 
Productive cough † 1  2/20 (10.00%)  0/14 (0.00%) 
Rhinitis allergic † 1  1/20 (5.00%)  0/14 (0.00%) 
Upper respiratory tract inflammation † 1  1/20 (5.00%)  0/14 (0.00%) 
Skin and subcutaneous tissue disorders     
Palmar-plantar erythrodysaesthesia syndrome † 1  16/20 (80.00%)  10/14 (71.43%) 
Rash † 1  3/20 (15.00%)  4/14 (28.57%) 
Alopecia † 1  3/20 (15.00%)  1/14 (7.14%) 
Pruritus † 1  4/20 (20.00%)  0/14 (0.00%) 
Dermatitis acneiform † 1  1/20 (5.00%)  2/14 (14.29%) 
Dry skin † 1  1/20 (5.00%)  1/14 (7.14%) 
Rash maculo-papular † 1  0/20 (0.00%)  2/14 (14.29%) 
Decubitus ulcer † 1  0/20 (0.00%)  1/14 (7.14%) 
Eczema † 1  1/20 (5.00%)  0/14 (0.00%) 
Seborrhoeic dermatitis † 1  0/20 (0.00%)  1/14 (7.14%) 
Vascular disorders     
Hypertension † 1  9/20 (45.00%)  7/14 (50.00%) 
1
Term from vocabulary, MedDRA22.0
†
Indicates events were collected by systematic assessment
[Not Specified]
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 first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03586973    
Other Study ID Numbers: Cabozantinib-2003
U1111-1214-6141 ( Other Identifier: WHO )
JapicCTI-184018 ( Registry Identifier: JapicCTI )
First Submitted: June 29, 2018
First Posted: July 16, 2018
Results First Submitted: June 14, 2022
Results First Posted: April 18, 2023
Last Update Posted: April 18, 2023