Drug: |
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Trial Name: |
A Phase 3 Study of Ripretinib vs Sunitinib in Patients With Advanced GIST With Specific KIT Exon Mutations Who Were Previously Treated With Imatinib (INSIGHT) |
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NCT#: |
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Conditions: |
Gastrointestinal Stromal Tumor |
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Status: |
Recruiting |
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Phase: |
3 |
Start Date 12/13/2023 |
Age of Trial (yrs) 1 |
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Treatment Phase: |
Gleevec-resistant |
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Drug Category: |
KIT/PDGFRA inhibitor |
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Strategy: |
Block KIT |
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Trial Type: |
Specifically GIST and only GIST |
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Other Protocol IDs: |
DCC-2618-03-003 |
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Sponsor: |
Deciphera Pharmaceuticals, Inc. |
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Patient Contact: |
Clinical Team
785-830-2100 Clinicaltrials@deciphera.com |
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Contact email: |
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Contact Phone: |
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Randomized: |
Randomized |
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IV or Oral: |
Oral |
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Trial Notes: |
Brief Summary: This is a Phase 3, 2-arm, randomized, open-label, global, multicenter study comparing the efficacy of ripretinib to sunitinib in participants with GIST who progressed on first-line treatment with imatinib, harbor co-occurring KIT exons 11+17/18 mutations, and are without KIT exon 9, 13, or 14 mutations. Upon disease progression as determined by an independent radiologic review, participants randomized to sunitinib will be given the option to either crossover to receive ripretinib 150 mg QD or discontinue sunitinib. Partial Criteria (see clinicaltrials.gov listing for full criteria) Partial Inclusion Criteria: (see clinicaltrials.gov listing for full criteria) Male or female ≥18 years of age. Histologic diagnosis of GIST with co-occurring KIT exons 11+17/18 mutations confirmed by ctDNA sample. (Circulating tumor DNA) Participants must have advanced GIST and radiologic progression on imatinib treatment. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2 at screening. Partial Exclusion Criteria: (see clinicaltrials.gov listing for full criteria) History of KIT exon 9 mutation or detection of KIT exon 9, 13, or 14 mutations in a ctDNA sample. (Circulating Tumor DNA) |
Trial Links |
Trial Results |
Name |
Address |
City |
State |
Zip |
Country |
Portland |
OR |
97239 |
USA |
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610 University Ave |
Toronto |
ON |
M5G 2M9 |
Canada |
|
Cleveland |
OH |
44195 |
USA |
||
450 Brookline Ave |
Boston |
MA |
02215-5450 |
USA |
|
1275 York Ave |
New York |
NY |
10065 |
USA |
|
La Jolla |
CA |
92093 |
USA |
||
333 Cedar St |
New Haven |
CT |
06510 |
USA |
|
Jacksonville |
FL |
32224 |
USA |
||
Baltimore |
MD |
21231 |
USA |
||
Minneapolis |
MN |
55455 |
USA |
||
Rochester |
MN |
55905 |
USA |
||
Hyde Park |
NY |
11042 |
USA |
||
Columbus |
OH |
43210 |
USA |
||
Oklahoma City |
OK |
73104 |
USA |
||
1505 Holcombe Blvd. |
Houston |
TX |
77030 |
USA |
|
Seattle |
WA |
98109 |
USA |
||
The Slfred Hospital |
Melbourne |
VIC |
Australia |
||
Florianopolis |
Brazil |
||||
Rio De Janeiro |
20.230-130 |
Brazil |
|||
Hamilton |
ON |
L8V 5C2 |
Canada |
||
Montreal |
QC |
H4A 3J1 |
Canada |
||
Las Condes |
HFXR+R4 |
Chile |
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28 rue Laennec |
Lyon |
Rhone |
69373 |
France |
|
Villejuif |
Val de Narne |
94805 |
France |
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Schwanebecker Chaussee |
Berlin |
Germany |
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Napoli |
80131 |
Italy |
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Bologna |
40138 |
Italy |
|||
via Giacomo |
Milan |
20133 |
Italy |
||
Padova |
Italy |
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Palermo |
90127 |
Italy |
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Roma |
00128 |
Italy |
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Seoul |
Songpa-gu |
138-736 |
Republic of Korea |
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Seoul |
Republic of Korea |
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Groningen |
9713 GZ |
Netherlands |
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Leiden |
2333 |
Netherlands |
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Warsaw |
02-781 |
Poland |
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Vigo |
Spain |
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Barcelona |
08041 |
Spain |
|||
119-129 |
Barcelona |
08035 |
Spain |
||
Valencia |
Spain |
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Taichung |
Taiwan |
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Taipei |
Taiwan |
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Leeds |
UK |
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197 Fulham Rd. |
London |
SW3 6JJ |
UK |
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Aguascalientes |
20116 |
Mexico |
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Oaxaca |
68000 |
Mexico |
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1475 Northwest 12th Ave |
Miami |
FL |
33136 |
USA |
|
Boston |
MA |
02118 |
USA |
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Barker Street |
Randwick |
New South Wales |
2031 |
Australia |
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Barettos |
Sao Paulo |
14748-400 |
Brazil |
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Sao Paulo |
Sao Paulo |
01308 |
Brazil |
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Sao Paulo |
Sao Paulo |
01409-002 |
Brazil |
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Sao Paulo |
01509-900 |
Brazil |