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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03673501




Registration number
NCT03673501
Ethics application status
Date submitted
13/09/2018
Date registered
17/09/2018

Titles & IDs
Public title
A Study of Ripretinib vs Sunitinib in Advanced GIST Patients After Treatment With Imatinib
Scientific title
A Phase 3, Interventional, Randomized, Multicenter, Open-Label Study of Ripretinib vs Sunitinib in Patients With Advanced Gastrointestinal Stromal Tumor (GIST) After Treatment With Imatinib
Secondary ID [1] 0 0
DCC-2618-03-002
Universal Trial Number (UTN)
Trial acronym
INTRIGUE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Stromal Tumors 0 0
Condition category
Condition code
Cancer 0 0 0 0
Stomach
Cancer 0 0 0 0
Bowel - Small bowel (duodenum and ileum)
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ripretinib
Treatment: Drugs - Sunitinib

Experimental: Ripretinib - Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles

Active comparator: Sunitinib - Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.


Treatment: Drugs: Ripretinib
Oral KIT/PDGFRA kinase inhibitor

Treatment: Drugs: Sunitinib
Oral receptor tyrosine kinase (RTK) inhibitor
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS) in the KIT Exon 11 Intent to Treat (ITT) Population
Timepoint [1] 0 0
From date of randomization to earliest documented evidence of disease progression, or death due to any cause (up to 2.1 years)
Primary outcome [2] 0 0
Progression Free Survival (PFS) in the All Patient (AP) Intent to Treat (ITT) Population
Timepoint [2] 0 0
From date of randomization to earliest documented evidence of disease progression, or death due to any cause (up to 2.1 years)
Secondary outcome [1] 0 0
Objective Response Rate (ORR) in the KIT Exon 11 Intent to Treat (ITT) Population Population
Timepoint [1] 0 0
From confirmed CR or PR to disease progression (up to 1.74 years)
Secondary outcome [2] 0 0
Objective Response Rate (ORR) in the All Patient (AP) Intent to Treat (ITT) Population
Timepoint [2] 0 0
From confirmed CR or PR to disease progression (up to 1.74 years)
Secondary outcome [3] 0 0
Overall Survival (OS) in the KIT Exon 11 Intent to Treat (ITT) Population
Timepoint [3] 0 0
From date of randomization until death due to any cause (up to 3.33 years)
Secondary outcome [4] 0 0
Overall Survival (OS) in the All Patient (AP) Intent to Treat (ITT) Population
Timepoint [4] 0 0
From date of randomization until death due to any cause (up to 3.33 years)

Eligibility
Key inclusion criteria
1. Patients = 18 years of age at the time of informed consent.
2. Histologic diagnosis of GIST and must be able to provide an archival tumor tissue sample, otherwise, a fresh biopsy is required.
3. Molecular pathology report must be available. If molecular pathology report is not available or insufficient, an archival tumor tissue sample or fresh biopsy is required for mutation status confirmation by the central laboratory prior to randomization.
4. Patients must have progressed on imatinib or have documented intolerance to imatinib.
5. Eastern Cooperative Oncology Group (ECOG) Performance Score (PS) of = 2 at screening.
6. Female patients of childbearing potential must have a negative serum beta-human chorionic gonadotropin (ß-hCG) pregnancy test at screening and negative pregnancy test at Cycle 1 Day 1 prior to the first dose of study drug.
7. Patients of reproductive potential must agree to follow the contraception requirements outlined in the study protocol.
8. Patients must have at least 1 measurable lesion according to Modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1 (non nodal lesions must be = 1.0 cm in the long axis or = double the slice thickness in the long axis) within 21 days prior to the first dose of study drug.
9. Adequate organ function and bone marrow reserve as indicated by the central laboratory assessments performed at screening.
10. Resolution of all toxicities from prior therapy to = Grade 1 (or patient baseline) within 1 week prior to the first dose of study drug (excluding alopecia and = Grade 3 clinically asymptomatic lipase, amylase, and creatine phosphokinase laboratory abnormalities).
11. The patient is capable of understanding and complying with the protocol and the patient has signed the informed consent document. Signed informed consent form (ICF) must be obtained before any study-specific procedures are performed and the patient must agree to not participate in any other interventional clinical trial while on treatment in this clinical trial. Participation in a noninterventional study (including observational studies) is permitted.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Treatment with any other line of therapy in addition to imatinib for advanced GIST. Imatinib-containing combination therapy in the first-line setting is not allowed.
2. Patients with a prior or concurrent malignancy whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of this clinical trial are not eligible.
3. Patient has known active central nervous system metastases.
4. New York Heart Association class II-IV heart disease, myocardial infarction within 6 months of cycle 1 day 1, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure.
5. Left ventricular ejection fraction (LVEF) < 50% at screening.
6. Arterial thrombotic or embolic events such as cerebrovascular accident (including ischemic attacks) or hemoptysis within 6 months before the first dose of study drug.
7. Venous thrombotic events (e.g. deep vein thrombosis) or pulmonary arterial events (e.g. pulmonary embolism) within 1 month before the first dose of study drug. Patients on stable anticoagulation therapy for at least one month are eligible.
8. 12-lead ECG demonstrating QT interval corrected (QTc) by Fridericia's formula > 450 ms in males or > 470 ms in females at screening or history of long QTc syndrome
9. Use of known substrates or inhibitors of breast cancer resistance protein (BCRP) transporters within 14 days or 5 x the half-life (whichever is longer) prior to the first dose of study drug.
10. Major surgeries (e.g. abdominal laparotomy) within 4 weeks of the first dose of study drug. All major surgical wounds must be healed and free of infection or dehiscence before the first dose of study drug.
11. Any other clinically significant comorbidities.
12. Known human immunodeficiency virus or hepatitis C infection only if the patient is taking medications that are excluded per protocol, active hepatitis B, or active hepatitis C infection.
13. If female, the patient is pregnant or lactating.
14. Known allergy or hypersensitivity to any component of the study drug.
15. Gastrointestinal abnormalities including but not limited to:

* inability to take oral medication
* malabsorption syndromes
* requirement for intravenous (IV) alimentation
16. Any active bleeding excluding hemorrhoidal or gum bleeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
Accrual to date
Final
453
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Border Medical Oncology Research Unit - Albury
Recruitment hospital [2] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 0 0
Ashford Cancer Centre Research - Kurralta Park
Recruitment hospital [5] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [6] 0 0
Princess Alexandara Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
- Albury
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
- Woolloongabba
Recruitment postcode(s) [4] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [5] 0 0
- Kurralta Park
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
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Colorado
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State/province [4] 0 0
Connecticut
Country [5] 0 0
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District of Columbia
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Florida
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Georgia
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Illinois
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Indiana
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Iowa
Country [11] 0 0
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Kentucky
Country [12] 0 0
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Maryland
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Massachusetts
Country [14] 0 0
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Michigan
Country [15] 0 0
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Minnesota
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Missouri
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Virginia
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Washington
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Wisconsin
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Argentina
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Cordoba
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Argentina
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Buenos Aires
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Belgium
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Bruxelles
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Belgium
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Leuven
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Canada
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Alberta
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Canada
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Manitoba
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Ontario
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Canada
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Québec
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Chile
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Santiago
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Czechia
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Prague
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France
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Bordeaux
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France
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Dijon
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France
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Lille Cedex
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France
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Lyon
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Marseille
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France
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Paris
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France
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Poitiers
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France
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Saint Herblain
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Essen
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Hungary
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Budapest
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Hungary
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Debrecen
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Israel
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Be'er Ya'akov
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Israel
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Petah Tikva
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Israel
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Tel Aviv
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Bologna
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Meldola
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Milan
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Padova
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Italy
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Palermo
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Italy
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Rome
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon
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Netherlands
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Amsterdam
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Netherlands
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Groningen
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Netherlands
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Leiden
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Norway
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Oslo
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Poland
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Warsaw
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Singapore
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Singapore
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Spain
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Barcelona
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Spain
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Bilbao
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Spain
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Madrid
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Spain
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Malaga
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Sevilla
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Valencia
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Spain
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Vigo
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Sweden
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Solna
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Switzerland
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Lausanne
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Switzerland
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Zurich
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Taiwan
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Taoyuan County
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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United Kingdom
State/province [84] 0 0
Glasgow
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United Kingdom
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Leeds
Country [86] 0 0
United Kingdom
State/province [86] 0 0
London
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Deciphera Pharmaceuticals, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03673501