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
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Sponsor:
Deciphera Pharmaceuticals LLC
Information provided by (Responsible Party):
Deciphera Pharmaceuticals LLC
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Study Type | Interventional |
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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 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Ripretinib | Sunitinib |
---|---|---|
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.
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Baseline Characteristics
Arm/Group Title | Ripretinib | Sunitinib | Total | |
---|---|---|---|---|
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 | |
Baseline Analysis Population Description |
[Not Specified]
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Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 226 participants | 227 participants | 453 participants | |
18-64 years |
145 64.2%
|
143 63.0%
|
288 63.6%
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65-74 years |
56 24.8%
|
66 29.1%
|
122 26.9%
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75 years and older |
25 11.1%
|
18 7.9%
|
43 9.5%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 226 participants | 227 participants | 453 participants | |
Female |
87 38.5%
|
85 37.4%
|
172 38.0%
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|
Male |
139 61.5%
|
142 62.6%
|
281 62.0%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 226 participants | 227 participants | 453 participants | |
Black or African American |
14 6.2%
|
14 6.2%
|
28 6.2%
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American Indian or Alaska Native |
0 0.0%
|
1 0.4%
|
1 0.2%
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Asian |
31 13.7%
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27 11.9%
|
58 12.8%
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Native Hawaiian or Other Pacific Islander |
2 0.9%
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1 0.4%
|
3 0.7%
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White |
148 65.5%
|
152 67.0%
|
300 66.2%
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Not Report |
30 13.3%
|
30 13.2%
|
60 13.2%
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Other |
1 0.4%
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2 0.9%
|
3 0.7%
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Eastern Cooperative Oncology Group (ECOG) Score at Screening
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 226 participants | 227 participants | 453 participants | |
ECOG Score 0 |
131 58.0%
|
128 56.4%
|
259 57.2%
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ECOG Score 1 |
92 40.7%
|
98 43.2%
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190 41.9%
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ECOG Score 2 |
3 1.3%
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1 0.4%
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4 0.9%
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[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 |
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Mutation Type per Electronic Data Capture (EDC)
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 226 participants | 227 participants | 453 participants | |
KIT Exon 9 |
31 13.7%
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28 12.3%
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59 13.0%
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KIT Exon 11 |
167 73.9%
|
169 74.4%
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336 74.2%
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KIT/PDGFRA WT |
14 6.2%
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16 7.0%
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30 6.6%
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Other KIT (absence of Exon 9 or 11)/PDGFRA |
14 6.2%
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14 6.2%
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28 6.2%
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[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.
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Intolerance to Imatinib per Electronic Data Capture (EDC)
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 226 participants | 227 participants | 453 participants | |
Yes |
15 6.6%
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19 8.4%
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34 7.5%
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No |
211 93.4%
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208 91.6%
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419 92.5%
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[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.
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Mutation Type per Interactive Response Technology (IRT)
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 226 participants | 227 participants | 453 participants | |
KIT Exon 9 |
31 13.7%
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29 12.8%
|
60 13.2%
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KIT Exon 11 |
163 72.1%
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164 72.2%
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327 72.2%
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KIT/PDGFRA wild type (WT) |
15 6.6%
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18 7.9%
|
33 7.3%
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Other KIT (absence of Exon 9 or 11)/PDGFRA |
17 7.5%
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16 7.0%
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33 7.3%
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[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
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Intolerance to Imatinib per Interactive Response Technology (IRT)
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 226 participants | 227 participants | 453 participants | |
Yes |
22 9.7%
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23 10.1%
|
45 9.9%
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No |
204 90.3%
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204 89.9%
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408 90.1%
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[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.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
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):
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 |