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Trial record 128 of 350 for:    Gastrointestinal Stromal Tumors
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A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib (INTRIGUE)

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ClinicalTrials.gov Identifier: NCT03673501
Recruitment Status : Active, not recruiting
First Posted : September 17, 2018
Results First Posted : January 2, 2024
Last Update Posted : January 2, 2024
Sponsor:
Information provided by (Responsible Party):
Deciphera Pharmaceuticals LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gastrointestinal Stromal Tumors
Interventions Drug: Ripretinib
Drug: Sunitinib
Enrollment 453
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ripretinib Sunitinib
Hide Arm/Group Description Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
Period Title: Overall Study
Started 226 227
Completed [1] 190 203
Not Completed 36 24
Reason Not Completed
Participants ongoing.             36             24
[1]
Completed patients are defined as patients that are followed until death or until the sponsor terminates the study.
Arm/Group Title Ripretinib Sunitinib Total
Hide Arm/Group Description Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break. Total of all reporting groups
Overall Number of Baseline Participants 226 227 453
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 226 participants 227 participants 453 participants
18-64 years
145
  64.2%
143
  63.0%
288
  63.6%
65-74 years
56
  24.8%
66
  29.1%
122
  26.9%
75 years and older
25
  11.1%
18
   7.9%
43
   9.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 226 participants 227 participants 453 participants
Female
87
  38.5%
85
  37.4%
172
  38.0%
Male
139
  61.5%
142
  62.6%
281
  62.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 226 participants 227 participants 453 participants
Black or African American
14
   6.2%
14
   6.2%
28
   6.2%
American Indian or Alaska Native
0
   0.0%
1
   0.4%
1
   0.2%
Asian
31
  13.7%
27
  11.9%
58
  12.8%
Native Hawaiian or Other Pacific Islander
2
   0.9%
1
   0.4%
3
   0.7%
White
148
  65.5%
152
  67.0%
300
  66.2%
Not Report
30
  13.3%
30
  13.2%
60
  13.2%
Other
1
   0.4%
2
   0.9%
3
   0.7%
Eastern Cooperative Oncology Group (ECOG) Score at Screening   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 226 participants 227 participants 453 participants
ECOG Score 0
131
  58.0%
128
  56.4%
259
  57.2%
ECOG Score 1
92
  40.7%
98
  43.2%
190
  41.9%
ECOG Score 2
3
   1.3%
1
   0.4%
4
   0.9%
[1]
Measure Description:

An ECOG Score of 0 means the participant is fully active, able to carry on all pre-disease performance without restriction

ECOG Score of 1 means the participant is restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light house work, office work

ECOG Score of 2 means the participant is ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours
Mutation Type per Electronic Data Capture (EDC)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 226 participants 227 participants 453 participants
KIT Exon 9
31
  13.7%
28
  12.3%
59
  13.0%
KIT Exon 11
167
  73.9%
169
  74.4%
336
  74.2%
KIT/PDGFRA WT
14
   6.2%
16
   7.0%
30
   6.6%
Other KIT (absence of Exon 9 or 11)/PDGFRA
14
   6.2%
14
   6.2%
28
   6.2%
[1]
Measure Description: Electronic Data Capture (EDC) is a system used to capture patient information in a clinical trial. The data is presented based on how many participants had the KIT proto-oncogene receptor tyrosine kinase (KIT) Exon 9 mutation, KIT Exon 11 mutation, the KIT/platelet-derived growth factor receptor alpha (PDGFRA) wild type (WT) mutation, or other KIT (absence of Exon 9 or 11)/PDGFRA mutations.
Intolerance to Imatinib per Electronic Data Capture (EDC)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 226 participants 227 participants 453 participants
Yes
15
   6.6%
19
   8.4%
34
   7.5%
No
211
  93.4%
208
  91.6%
419
  92.5%
[1]
Measure Description: Electronic Data Capture (EDC) is a system used to capture patient information in a clinical trial. The data is presented based on participants that were intolerant to imatinib or not.
Mutation Type per Interactive Response Technology (IRT)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 226 participants 227 participants 453 participants
KIT Exon 9
31
  13.7%
29
  12.8%
60
  13.2%
KIT Exon 11
163
  72.1%
164
  72.2%
327
  72.2%
KIT/PDGFRA wild type (WT)
15
   6.6%
18
   7.9%
33
   7.3%
Other KIT (absence of Exon 9 or 11)/PDGFRA
17
   7.5%
16
   7.0%
33
   7.3%
[1]
Measure Description: Interactive Response Technology (IRT) is a randomization and trial supply system that randomly assigns patients to one of the study treatments and supplies study drug. The data is presented based on the participant's Mutational Status: KIT exon 9 mutation; KIT exon 11 mutation; KIT/PDGFRA wild type (WT); or other KIT (absence of exon 9 or 11)/PDGFRA mutations
Intolerance to Imatinib per Interactive Response Technology (IRT)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 226 participants 227 participants 453 participants
Yes
22
   9.7%
23
  10.1%
45
   9.9%
No
204
  90.3%
204
  89.9%
408
  90.1%
[1]
Measure Description: Interactive Response Technology (IRT) is a randomization and trial supply system that randomly assigns patients to one of the study treatments and supplies study drug. The data is presented based on whether the participants were intolerant to imatinib or not.
1.Primary Outcome
Title Progression Free Survival (PFS) in the KIT Exon 11 Intent to Treat (ITT) Population
Hide Description PFS is defined as the interval between the date of randomization and the earliest documented evidence of disease progression based on the independent radiologic review using modified RECIST Version 1.1-(mRECIST 1.1) GIST specific, or death due to any cause. Per mRECIST 1.1, progression was defined using mRECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame From date of randomization to earliest documented evidence of disease progression, or death due to any cause (up to 2.1 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The KIT Exon 11 Intent to Treat (ITT) Population is defined as all patients who are designated as having a mutation in KIT Exon 11 at the time of randomization. Patients in this population will be analyzed according to the treatment they were scheduled to receive.
Arm/Group Title Ripretinib Sunitinib
Hide Arm/Group Description:
Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
Overall Number of Participants Analyzed 163 164
Median (95% Confidence Interval)
Unit of Measure: months
8.3
(6.8 to 13.3)
7.0
(5.6 to 10.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ripretinib, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3598
Comments [Not Specified]
Method Log Rank
Comments Strata: by intolerance to imatinib treatment
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.66 to 1.16
Estimation Comments [Not Specified]
2.Primary Outcome
Title Progression Free Survival (PFS) in the All Patient (AP) Intent to Treat (ITT) Population
Hide Description PFS is defined as the interval between the date of randomization and the earliest documented evidence of disease progression based on the independent radiologic review using modified RECIST Version 1.1-(mRECIST 1.1) Gastrointestinal stromal tumor (GIST) specific, or death due to any cause. Per mRECIST 1.1, progression was defined using mRECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame From date of randomization to earliest documented evidence of disease progression, or death due to any cause (up to 2.1 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All patient (AP) Intent to Treat (ITT) Population is defined as all patients who are randomized. Patients in this population will be analyzed according to the treatment they were scheduled to receive.
Arm/Group Title Ripretinib Sunitinib
Hide Arm/Group Description:
Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
Overall Number of Participants Analyzed 226 227
Median (95% Confidence Interval)
Unit of Measure: months
8.0
(6.5 to 10.8)
8.3
(6.3 to 11.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ripretinib, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7153
Comments Two-sided P-value
Method Log Rank
Comments Strata: mutation status (KIT exon 9 vs. 11 vs. KIT/PDGFRA WT vs. other KIT {absence of exon 9 or 11}/PDGFRA) and intolerance to imatinib treatment
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.82 to 1.33
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Objective Response Rate (ORR) in the KIT Exon 11 Intent to Treat (ITT) Population Population
Hide Description ORR was defined as the proportion of patients with confirmed complete response (CR) + confirmed partial response (PR) based on independent radiologic review using modified RECIST (mRECIST) criteria as best overall response. Per mRECIST 1.1 criteria, complete response is defined as disappearance of all target lesions; partial response is defined as >=30% decrease in the sum of the longest diameter of target lesions.
Time Frame From confirmed CR or PR to disease progression (up to 1.74 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The KIT Exon 11 Intent to Treat (ITT) Population is defined as all patients who are designated as having a mutation in KIT Exon 11 at the time of randomization. Patients in this population will be analyzed according to the treatment they were scheduled to receive.
Arm/Group Title Ripretinib Sunitinib
Hide Arm/Group Description:
Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
Overall Number of Participants Analyzed 163 164
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
23.9
(17.6 to 31.2)
14.6
(9.6 to 21.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ripretinib, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0333
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Strata: intolerance to imatinib treatment
4.Secondary Outcome
Title Objective Response Rate (ORR) in the All Patient (AP) Intent to Treat (ITT) Population
Hide Description ORR was defined as the proportion of patients with confirmed complete response (CR) + confirmed partial response (PR) based on independent radiologic review using modified RECIST (mRECIST) criteria as best overall response. Per mRECIST 1.1 criteria, complete response is defined as disappearance of all target lesions; partial response is defined as >=30% decrease in the sum of the longest diameter of target lesions.
Time Frame From confirmed CR or PR to disease progression (up to 1.74 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All patient (AP) Intent to Treat (ITT) Population is defined as all patients who are randomized. Patients in this population will be analyzed according to the treatment they were scheduled to receive.
Arm/Group Title Ripretinib Sunitinib
Hide Arm/Group Description:
Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
Overall Number of Participants Analyzed 226 227
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
21.7
(16.5 to 27.6)
17.6
(12.9 to 23.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ripretinib, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2681
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Strata: mutation status (KIT exon 9 vs. 11 vs. KIT/PDGFRA WT vs. other KIT {absence of exon 9 or 11}/PDGFRA) and intolerance to imatinib treatment
5.Secondary Outcome
Title Overall Survival (OS) in the KIT Exon 11 Intent to Treat (ITT) Population
Hide Description OS was defined as the time from the date of randomization until death due to any cause.
Time Frame From date of randomization until death due to any cause (up to 3.33 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The KIT Exon 11 Intent to Treat (ITT) Population is defined as all patients who are designated as having a mutation in KIT Exon 11 at the time of randomization. Patients in this population will be analyzed according to the treatment they were scheduled to receive.
Arm/Group Title Ripretinib Sunitinib
Hide Arm/Group Description:
Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
Overall Number of Participants Analyzed 163 164
Median (95% Confidence Interval)
Unit of Measure: months
34.0 [1] 
(29.3 to NA)
31.5 [1] 
(29.4 to NA)
[1]
Upper limit of 95% confidence interval (CI) was not estimable due to fewer number of participants with events
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ripretinib, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7733
Comments [Not Specified]
Method Log Rank
Comments Strata: intolerance to imatinib treatment
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.75 to 1.48
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Overall Survival (OS) in the All Patient (AP) Intent to Treat (ITT) Population
Hide Description OS was defined as the time from the date of randomization until death due to any cause.
Time Frame From date of randomization until death due to any cause (up to 3.33 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All patient (AP) Intent to Treat (ITT) Population is defined as all patients who are randomized. Patients in this population will be analyzed according to the treatment they were scheduled to receive.
Arm/Group Title Ripretinib Sunitinib
Hide Arm/Group Description:
Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
Overall Number of Participants Analyzed 226 227
Median (95% Confidence Interval)
Unit of Measure: months
35.5 [1] 
(29.3 to NA)
30.9 [1] 
(28.9 to NA)
[1]
Upper limit of 95% confidence interval (CI) was not estimable due to fewer number of participants with events
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ripretinib, Sunitinib
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3928
Comments [Not Specified]
Method Log Rank
Comments Strata: mutation status (KIT exon 9 vs. 11 vs. KIT/PDGFRA WT vs. other KIT {absence of exon 9 or 11}/PDGFRA) and intolerance to imatinib
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.66 to 1.18
Estimation Comments [Not Specified]
Time Frame Collection of Adverse events started from the signing of informed consent through safety follow-up (up to 3.22 years)
Adverse Event Reporting Description The Safety Population is defined as all patients who are randomized and receive at least one dose of study drug.
 
Arm/Group Title Ripretinib Sunitinib
Hide Arm/Group Description Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
All-Cause Mortality
Ripretinib Sunitinib
Affected / at Risk (%) Affected / at Risk (%)
Total   90/223 (40.36%)   95/221 (42.99%) 
Hide Serious Adverse Events
Ripretinib Sunitinib
Affected / at Risk (%) Affected / at Risk (%)
Total   64/223 (28.70%)   61/221 (27.60%) 
Blood and lymphatic system disorders     
Anaemia †  4/223 (1.79%)  2/221 (0.90%) 
Febrile neutropenia †  0/223 (0.00%)  1/221 (0.45%) 
Cardiac disorders     
Atrial fibrillation †  3/223 (1.35%)  0/221 (0.00%) 
Acute myocardial infarction †  1/223 (0.45%)  0/221 (0.00%) 
Angina pectoris †  1/223 (0.45%)  0/221 (0.00%) 
Atrioventricular block complete †  1/223 (0.45%)  0/221 (0.00%) 
Cardiac failure congestive †  1/223 (0.45%)  0/221 (0.00%) 
Cardiac failure †  0/223 (0.00%)  1/221 (0.45%) 
Left ventricular dysfunction †  0/223 (0.00%)  1/221 (0.45%) 
Cardiac failure acute †  1/223 (0.45%)  0/221 (0.00%) 
Supraventricular extrasustoles †  1/223 (0.45%)  0/221 (0.00%) 
Cardiac arrest †  0/223 (0.00%)  1/221 (0.45%) 
Gastrointestinal disorders     
Abdominal pain †  6/223 (2.69%)  6/221 (2.71%) 
Ascites †  2/223 (0.90%)  1/221 (0.45%) 
Small intestinal obstruction †  2/223 (0.90%)  2/221 (0.90%) 
Diarrhoea †  1/223 (0.45%)  2/221 (0.90%) 
Faecaloma †  1/223 (0.45%)  0/221 (0.00%) 
Gastric ulcer †  1/223 (0.45%)  0/221 (0.00%) 
Gastrointestinal haemorrhage †  1/223 (0.45%)  1/221 (0.45%) 
Intestinal obstruction †  1/223 (0.45%)  1/221 (0.45%) 
Intra-abdominal haemorrhage †  1/223 (0.45%)  0/221 (0.00%) 
Large intestine perforation †  1/223 (0.45%)  0/221 (0.00%) 
Lower gastrointestinal haemorrhage †  1/223 (0.45%)  0/221 (0.00%) 
Nausea †  1/223 (0.45%)  1/221 (0.45%) 
Pancreatitis †  1/223 (0.45%)  0/221 (0.00%) 
Vomiting †  2/223 (0.90%)  1/221 (0.45%) 
Abdominal pain lower †  0/223 (0.00%)  1/221 (0.45%) 
Colitis †  0/223 (0.00%)  1/221 (0.45%) 
Constipation †  0/223 (0.00%)  1/221 (0.45%) 
Enteritis †  0/223 (0.00%)  1/221 (0.45%) 
Gastric haemorrhage †  0/223 (0.00%)  1/221 (0.45%) 
Gastrointestinal perforation †  0/223 (0.00%)  2/221 (0.90%) 
Haematemesis †  0/223 (0.00%)  1/221 (0.45%) 
Haemoperitoneum †  0/223 (0.00%)  1/221 (0.45%) 
Haemorrhoidal haemorrhage †  0/223 (0.00%)  1/221 (0.45%) 
Intestinal ischaemia †  0/223 (0.00%)  1/221 (0.45%) 
Periodontal disease †  0/223 (0.00%)  1/221 (0.45%) 
Diverticulum intestinal haemorrhagic †  1/223 (0.45%)  0/221 (0.00%) 
General disorders     
General physical health deterioration †  5/223 (2.24%)  0/221 (0.00%) 
Localised oedema †  1/223 (0.45%)  0/221 (0.00%) 
Malaise †  1/223 (0.45%)  0/221 (0.00%) 
Oedema peripheral †  1/223 (0.45%)  0/221 (0.00%) 
Asthenia †  0/223 (0.00%)  1/221 (0.45%) 
Fatigue †  0/223 (0.00%)  1/221 (0.45%) 
Pyrexia †  0/223 (0.00%)  2/221 (0.90%) 
Disease progression †  1/223 (0.45%)  0/221 (0.00%) 
Sudden death †  0/223 (0.00%)  1/221 (0.45%) 
Hepatobiliary disorders     
Acute hepatic failure †  1/223 (0.45%)  0/221 (0.00%) 
Biliary obstruction †  1/223 (0.45%)  1/221 (0.45%) 
Hepatic pain †  1/223 (0.45%)  0/221 (0.00%) 
Cholecystitis acute †  0/223 (0.00%)  1/221 (0.45%) 
Cholelithiasis †  0/223 (0.00%)  1/221 (0.45%) 
Hepatic haemorrhage †  0/223 (0.00%)  1/221 (0.45%) 
Immune system disorders     
Hypersensitivity †  1/223 (0.45%)  0/221 (0.00%) 
Infections and infestations     
COVID-19 †  5/223 (2.24%)  2/221 (0.90%) 
Cellulitis †  2/223 (0.90%)  0/221 (0.00%) 
Urinary tract infection †  2/223 (0.90%)  3/221 (1.36%) 
Abdominal abscess †  1/223 (0.45%)  1/221 (0.45%) 
Abdominal infection †  1/223 (0.45%)  0/221 (0.00%) 
Anorectal infection †  1/223 (0.45%)  0/221 (0.00%) 
Appendicitis †  1/223 (0.45%)  1/221 (0.45%) 
Diverticulitis †  1/223 (0.45%)  0/221 (0.00%) 
Enterococcal bacteraemia †  1/223 (0.45%)  1/221 (0.45%) 
Pelvic abscess †  1/223 (0.45%)  0/221 (0.00%) 
Perirectal abscess †  1/223 (0.45%)  1/221 (0.45%) 
Pneumonia †  2/223 (0.90%)  1/221 (0.45%) 
Vestibular neuronitis †  1/223 (0.45%)  0/221 (0.00%) 
Viral upper respiratory tract infection †  1/223 (0.45%)  0/221 (0.00%) 
Abdominal wall abscess †  0/223 (0.00%)  1/221 (0.45%) 
Escherichia peritonitis †  0/223 (0.00%)  1/221 (0.45%) 
Gastroenteritis †  0/223 (0.00%)  1/221 (0.45%) 
Infection †  0/223 (0.00%)  1/221 (0.45%) 
Sepsis †  0/223 (0.00%)  2/221 (0.90%) 
Tooth infection †  0/223 (0.00%)  1/221 (0.45%) 
Injury, poisoning and procedural complications     
Wound dehiscence †  1/223 (0.45%)  0/221 (0.00%) 
Accidental overdose †  0/223 (0.00%)  1/221 (0.45%) 
Acquired encephalocele †  1/223 (0.45%)  0/221 (0.00%) 
Metabolism and nutrition disorders     
Hypokalaemia †  2/223 (0.90%)  0/221 (0.00%) 
Dehydration †  1/223 (0.45%)  1/221 (0.45%) 
Hypocalcaemia †  1/223 (0.45%)  0/221 (0.00%) 
Hypoglycaemia †  1/223 (0.45%)  0/221 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain †  1/223 (0.45%)  0/221 (0.00%) 
Flank pain †  0/223 (0.00%)  1/221 (0.45%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Tumour pain †  2/223 (0.90%)  0/221 (0.00%) 
Acral lentiginous melanoma †  1/223 (0.45%)  0/221 (0.00%) 
Malignant melanoma †  1/223 (0.45%)  0/221 (0.00%) 
Adenocarcinoma gastric †  0/223 (0.00%)  1/221 (0.45%) 
Adenocarcinoma of colon †  0/223 (0.00%)  1/221 (0.45%) 
Transitional cell carcinoma †  0/223 (0.00%)  1/221 (0.45%) 
Tumour haemorrhage †  0/223 (0.00%)  2/221 (0.90%) 
Tumour rupture †  0/223 (0.00%)  1/221 (0.45%) 
Bowen's disease †  1/223 (0.45%)  0/221 (0.00%) 
Nervous system disorders     
Encephalopathy †  1/223 (0.45%)  0/221 (0.00%) 
Cerebrovascular accident †  0/223 (0.00%)  1/221 (0.45%) 
Haemorrhage intracranial †  0/223 (0.00%)  1/221 (0.45%) 
Syncope †  0/223 (0.00%)  1/221 (0.45%) 
Seizure †  0/223 (0.00%)  1/221 (0.45%) 
Psychiatric disorders     
Confusional state †  2/223 (0.90%)  1/221 (0.45%) 
Psychomotor retardation †  0/223 (0.00%)  1/221 (0.45%) 
Renal and urinary disorders     
Acute kidney injury †  1/223 (0.45%)  1/221 (0.45%) 
Renal failure †  0/223 (0.00%)  1/221 (0.45%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea †  2/223 (0.90%)  1/221 (0.45%) 
Pulmonary embolism †  2/223 (0.90%)  2/221 (0.90%) 
Pleural effusion †  1/223 (0.45%)  2/221 (0.90%) 
Respiratory failure †  0/223 (0.00%)  1/221 (0.45%) 
Skin and subcutaneous tissue disorders     
Skin ulcer †  0/223 (0.00%)  1/221 (0.45%) 
Vascular disorders     
Hypertensive crisis †  1/223 (0.45%)  2/221 (0.90%) 
Hypertensive urgency †  1/223 (0.45%)  0/221 (0.00%) 
Superior vena cava syndrome †  1/223 (0.45%)  0/221 (0.00%) 
Aortic aneurysm †  0/223 (0.00%)  1/221 (0.45%) 
Deep vein thrombosis †  0/223 (0.00%)  1/221 (0.45%) 
Hypotension †  0/223 (0.00%)  1/221 (0.45%) 
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ripretinib Sunitinib
Affected / at Risk (%) Affected / at Risk (%)
Total   221/223 (99.10%)   219/221 (99.10%) 
Blood and lymphatic system disorders     
Anaemia †  25/223 (11.21%)  31/221 (14.03%) 
Thrombocytopenia †  2/223 (0.90%)  14/221 (6.33%) 
Neutropenia †  0/223 (0.00%)  28/221 (12.67%) 
Gastrointestinal disorders     
Constipation †  79/223 (35.43%)  48/221 (21.72%) 
Abdominal pain †  57/223 (25.56%)  35/221 (15.84%) 
Nausea †  54/223 (24.22%)  56/221 (25.34%) 
Diarrhoea †  47/223 (21.08%)  107/221 (48.42%) 
Vomiting †  27/223 (12.11%)  31/221 (14.03%) 
Dyspepsia †  19/223 (8.52%)  38/221 (17.19%) 
Abdominal distension †  17/223 (7.62%)  16/221 (7.24%) 
Stomatitis †  18/223 (8.07%)  81/221 (36.65%) 
Abdominal pain upper †  13/223 (5.83%)  23/221 (10.41%) 
Gastrooesophageal reflux disease †  7/223 (3.14%)  35/221 (15.84%) 
Dry mouth †  6/223 (2.69%)  13/221 (5.88%) 
Oral pain †  3/223 (1.35%)  13/221 (5.88%) 
General disorders     
Fatigue †  84/223 (37.67%)  91/221 (41.18%) 
Asthenia †  38/223 (17.04%)  41/221 (18.55%) 
Oedema peripheral †  19/223 (8.52%)  21/221 (9.50%) 
Pyrexia †  14/223 (6.28%)  20/221 (9.05%) 
Investigations     
Weight decreased †  40/223 (17.94%)  29/221 (13.12%) 
Blood bilirubin increased †  20/223 (8.97%)  16/221 (7.24%) 
Lipase increased †  19/223 (8.52%)  20/221 (9.05%) 
Aspartate aminotransferase increased †  15/223 (6.73%)  24/221 (10.86%) 
Alanine aminotransferase increased †  13/223 (5.83%)  15/221 (6.79%) 
Neutrophil count decreased †  2/223 (0.90%)  42/221 (19.00%) 
Platelet count decreased †  2/223 (0.90%)  32/221 (14.48%) 
White blood cell count decreased †  1/223 (0.45%)  22/221 (9.95%) 
Blood creatine phosphokinase increased †  7/223 (3.14%)  11/221 (4.98%) 
Metabolism and nutrition disorders     
Decreased appetite †  60/223 (26.91%)  54/221 (24.43%) 
Hypokalaemia †  8/223 (3.59%)  11/221 (4.98%) 
Hypertriglyceridaemia †  6/223 (2.69%)  12/221 (5.43%) 
Hypomagnesaemia †  4/223 (1.79%)  11/221 (4.98%) 
Musculoskeletal and connective tissue disorders     
Myalgia †  81/223 (36.32%)  25/221 (11.31%) 
Muscle spasms †  59/223 (26.46%)  15/221 (6.79%) 
Arthralgia †  38/223 (17.04%)  36/221 (16.29%) 
Back pain †  23/223 (10.31%)  16/221 (7.24%) 
Pain in extremity †  14/223 (6.28%)  16/221 (7.24%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Seborrhoeic keratosis †  26/223 (11.66%)  3/221 (1.36%) 
Melanocytic naevus †  23/223 (10.31%)  6/221 (2.71%) 
Tumour pain †  12/223 (5.38%)  12/221 (5.43%) 
Skin papilloma †  12/223 (5.38%)  0/221 (0.00%) 
Nervous system disorders     
Dizziness †  15/223 (6.73%)  18/221 (8.14%) 
Dysgeusia †  8/223 (3.59%)  33/221 (14.93%) 
Headache †  36/223 (16.14%)  39/221 (17.65%) 
Psychiatric disorders     
Insomnia †  19/223 (8.52%)  13/221 (5.88%) 
Anxiety †  14/223 (6.28%)  9/221 (4.07%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea †  27/223 (12.11%)  18/221 (8.14%) 
Cough †  23/223 (10.31%)  12/221 (5.43%) 
Dysphonia †  18/223 (8.07%)  4/221 (1.81%) 
Epistaxis †  5/223 (2.24%)  15/221 (6.79%) 
Oropharyngeal pain †  12/223 (5.38%)  9/221 (4.07%) 
Skin and subcutaneous tissue disorders     
Alopecia †  144/223 (64.57%)  18/221 (8.14%) 
Palmar-plantar erythrodysaesthesia syndrome †  61/223 (27.35%)  116/221 (52.49%) 
Pruritus †  49/223 (21.97%)  16/221 (7.24%) 
Dry skin †  33/223 (14.80%)  34/221 (15.38%) 
Rash maculo-papular †  28/223 (12.56%)  18/221 (8.14%) 
Pain of skin †  18/223 (8.07%)  5/221 (2.26%) 
Rash †  17/223 (7.62%)  14/221 (6.33%) 
Actinic keratosis †  15/223 (6.73%)  5/221 (2.26%) 
Hair colour changes †  5/223 (2.24%)  11/221 (4.98%) 
Vascular disorders     
Hypertension †  60/223 (26.91%)  106/221 (47.96%) 
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: INTRIGUE Clinical Team
Organization: Deciphera Pharmaceuticals, LLC
Phone: 781-209-6400
EMail: clinicaltrials@deciphera.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Deciphera Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT03673501    
Other Study ID Numbers: DCC-2618-03-002
First Submitted: September 13, 2018
First Posted: September 17, 2018
Results First Submitted: October 25, 2023
Results First Posted: January 2, 2024
Last Update Posted: January 2, 2024