Comparing 7 approaches for advanced gastrointestinal stromal tumors
Official title: (Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors
A Phase 3 Randomized, Open-Label, Multicenter Clinical Study of CGT9486+Sunitinib vs. Sunitinib in Subjects With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors
- Phase 3
- 7 groups
- Sites in Calgary, Montreal and 2 more cities
- Recruiting
Interventions (9)
- Medication
CGT9486
Participants will receive CGT9486 orally until study stopping rules are met.
- Medication
CGT9486
Participants will receive CGT9486 until steady state then both CGT9486 and sunitinib orally until study stopping rules are met.
- Medication
Sunitinib
Participants will receive sunitinib until steady state then both sunitinib and CGT9486 orally until study stopping rules are met.
- Medication
Sunitinib
Participants will receive sunitinib orally until study stopping rules are met.
- Medication
Midazolam
Participants will receive a single-dose of midazolam on Day 1 and Day 16
- Medication
CGT9486
Participants will receive CGT9486 orally starting on Day 2 until study stopping rules are met.
- Medication
Sunitinib
Participants will receive CGT9486 until steady state then both sunitinib and CGT9486 orally until study stopping rules are met.
- Medication
CGT9486
Participants will receive sunitinib until steady state then both CGT9486 and sunitinib orally until study stopping rules are met.
- Medication
Sunitinib
Participants will receive sunitinib orally starting on Day 16 until study stopping rules are met.
Canadian Sites (4)
4 listed, none recruiting
- Not currently recruiting
Alberta Health Services Cross Cancer Institute
Edmonton, Alberta
- Not currently recruiting
Tom Baker Cancer Center
Calgary
- Not currently recruiting
Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)
Montreal
- Not currently recruiting
Princess Margaret Hospital
Toronto, Ontario
Eligibility Criteria
See who this study is looking for21 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +0 to 2 (Part 1a, Part 1b, Part 2, DDI Substudy)
- +0 to 1 (GIST 1L Substudy)
- +Histologically confirmed locally advanced, metastatic, and/or unresectable GIST. Molecular pathology report must be available for Part 2; if molecular pathology report is unavailable or inadequate, an archival or fresh tumor tissue sample will be required to evaluate mutational status prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →. (GIST 1L Substudy: must have documented mutation in KIT Exon 9 with an available molecular pathology report; archival or fresh tumor tissue sample will be required)
- +Documented disease progression on or intolerance to imatinib (Part 1a, Part 1b, Part 2, DDI Substudy)
- +Subjects must have received the following treatment:
- +DDI Substudy/Part 1a: Treatment with ≥1 prior lines of therapy for GIST
- +Part 1b: Treatment with ≥2 prior TKI for GISTs
- +Part 2: Prior treatment with imatinib only
- +GIST 1L Substudy: No prior systemic therapy for GIST including adjuvant therapy. Exception: up to 10 subjects with ongoing imatinib therapy of ≤4 weeks
- +Have at least 1 measurable lesion according to mRECIST v1.1 (Part1a, Part 1b, Part 2, GIST 1L Substudy)
- +Eastern Cooperative Oncology Group (ECOG) Status
- +Have clinically acceptable local laboratory screeningScreeningThe checks done before joining, to see whether a study fits.Read more → results (clinical chemistry and hematology) within certain limits
Exclusion
- −Seropositive for HIV 1 or 2, or positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody.
- −Known Platelet-Derived Growth Factor Receptor (PDGFR) driving mutations or known succinate dehydrogenase deficiency (Part 1a, Part 1b, Part 2, DDI Substudy)
- −Clinically significant cardiac disease
- −Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug (Part 1a, Part 1b, Part 2, DDI Substudy)
- −Gastrointestinal abnormalities including, but not limited to, significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption
- −Any active bleeding excluding hemorrhoidal or gum bleeding
- −Active, uncontrolled, systemic bacterial, fungal, or viral infections at ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- −Received strong CYP3A4 inhibitors or inducers (Part 1a, Part 1b, Part 2, DDI Substudy)
- −Received sunitinib within 3 weeks (Part 1a, Part 1b, DDI Substudy)
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 7 groups in this study.
Groups A, B, D and G receive one or more of: CGT9486 and Sunitinib.
Registry label: A: Part 1a · B: Part 2 - Experimental Group · D: Part 1b - DDI Cohort 1 · G: GIST 1L Substudy
Group C, the comparison group, receives Sunitinib.
Registry label: C: Part 2 - Control Group
Group E receives one or more of: Sunitinib and CGT9486.
Registry label: E: Part 1b - DDI Cohort 2
Group F receives Midazolam, together with one or more of: CGT9486 and Sunitinib.
Registry label: F: DDI Substudy (Midazolam)
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 482 people.
The study is currently expected to finish around January 2030.
The main measurement is taken over: 16 days.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Part 1a - pharmacokineticsPharmacokineticsThe study of how the body absorbs, distributes, and clears a treatment.Read more → - Cmax — measured over 16 days.
Part 1a - pharmacokinetics - AUC — measured over 16 days.
Part 1b - pharmacokinetics - Cmax — measured over 14 days.
Part 1b - pharmacokinetics - AUC — measured over 14 days.
The study lists 4 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05208047 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About CGT9486Drug
Participants will receive CGT9486 orally until study stopping rules are met.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About CGT9486Drug
Participants will receive CGT9486 until steady state then both CGT9486 and sunitinib orally until study stopping rules are met.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About SunitinibDrug
Participants will receive sunitinib until steady state then both sunitinib and CGT9486 orally until study stopping rules are met.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About SunitinibDrug
Participants will receive sunitinib orally until study stopping rules are met.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About MidazolamDrug
Participants will receive a single-dose of midazolam on Day 1 and Day 16
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About CGT9486Drug
Participants will receive CGT9486 orally starting on Day 2 until study stopping rules are met.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About SunitinibDrug
Participants will receive CGT9486 until steady state then both sunitinib and CGT9486 orally until study stopping rules are met.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About CGT9486Drug
Participants will receive sunitinib until steady state then both CGT9486 and sunitinib orally until study stopping rules are met.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About SunitinibDrug
Participants will receive sunitinib orally starting on Day 16 until study stopping rules are met.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 16 days.
The study as a whole is currently expected to finish around 2030-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 482 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 9 locations, including: Calgary, Canada; Montreal, Canada; Edmonton, Alberta, Canada; Toronto, Ontario, Canada; Ann Arbor, Michigan, United States; Rochester, Minnesota, United States, and 3 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 482 patients. Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to be used in subsequent parts in approximately 20 patients who have received at least one prior line of therapy for Gastrointestinal Stromal Tumors (GIST) and 2) evaluating the potential for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase inhibitors (TKIs) for GISTs. The second part of the study will enroll approximately 388 patients who are intolerant to, or who failed prior treatment with imatinib only and will compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being randomized in a 1:1 manner. This study also contains two substudies: 1) a drug-drug interactions (DDI) substudy will investigate the potential for CGT9486 to be a Cytochrome P450 (CYP)3A4 inducer in approximately 16 patients who have received at least one prior line of therapy for GIST and 2) a substudy intended to test the efficacy of bezuclastinib and sunitinib as first-line (1L) treatment of GIST in approximately 40 participants with KIT exon 9 mutations and no prior systemic therapy (with the exception of up to 10 subjects with ongoing imatinib therapy of ≤4 weeks).
Other Sites (5)
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.