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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05208047
Registration number
NCT05208047
Ethics application status
Date submitted
23/12/2021
Date registered
26/01/2022
Titles & IDs
Public title
(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors
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Scientific title
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
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Secondary ID [1]
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CGT9486-21-301
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Gastrointestinal Stromal Tumors
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0
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Metastatic Cancer
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Condition category
Condition code
Cancer
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0
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0
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Stomach
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Cancer
0
0
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0
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Bowel - Small bowel (duodenum and ileum)
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Cancer
0
0
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0
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - CGT9486 plus sunitinib
Treatment: Drugs - CGT9486
Treatment: Drugs - Sunitinib
Treatment: Drugs - Sunitinib
Experimental: Part 1a - CGT9486 plus sunitinib 37.5 mg QD
Experimental: Part 2 - Experimental Group - CGT9486 plus sunitinib 37.5 mg QD
Active comparator: Part 2 - Control Group - sunitinib 37.5 mg QD
Experimental: Part 1b - DDI Cohort 1 - CGT9486 plus sunitinib 37.5 mg QD
Experimental: Part 1b - DDI Cohort 2 - sunitinib 37.5 mg QD plus CGT9486
Treatment: Drugs: CGT9486 plus sunitinib
Participants will receive both CGT9486 and sunitinib orally until study stopping rules are met.
Treatment: Drugs: CGT9486
Participants will receive CGT9486 until steady state then both CGT9486 and sunitinib orally until study stopping rules are met.
Treatment: Drugs: Sunitinib
Participants will receive sunitinib until steady state then both sunitinib and CGT9486 orally until study stopping rules are met.
Treatment: Drugs: Sunitinib
Participants will receive sunitinib orally until study stopping rules are met.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part 1a - pharmacokinetics - Cmax
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Assessment method [1]
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Maximum plasma concentration (Cmax)
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Timepoint [1]
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16 days
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Primary outcome [2]
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Part 1a - pharmacokinetics - AUC
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Assessment method [2]
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Area under the plasma concentration-time curve (AUC)
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Timepoint [2]
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16 days
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Primary outcome [3]
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0
Part 1b - pharmacokinetics - Cmax
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Assessment method [3]
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0
Maximum plasma concentration (Cmax)
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Timepoint [3]
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14 days
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Primary outcome [4]
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Part 1b - pharmacokinetics - AUC
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Assessment method [4]
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0
Area under the plasma concentration-time curve (AUC)
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Timepoint [4]
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14 days
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Primary outcome [5]
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Part 1b - pharmacokinetics - Tmax
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Assessment method [5]
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Time to maximum observed plasma concentration (Tmax)
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Timepoint [5]
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14 days
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Primary outcome [6]
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Part 2 - Progression Free Survival (PFS)
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Assessment method [6]
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Time from first dose to documented disease progression or death due to any cause, whichever occurs first
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Timepoint [6]
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Approximately 48 months
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Secondary outcome [1]
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All Study Parts - observing the safety of each treatment regimen.
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Assessment method [1]
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Incidence and severity of Adverse Events from first dose of study drug
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Timepoint [1]
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Approximately 48 months
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Secondary outcome [2]
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0
All Study Parts - observing the safety of each treatment regimen.
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Assessment method [2]
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Incidence and severity of Serious Adverse Events from first dose of study drug
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Timepoint [2]
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Approximately 48 months
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Secondary outcome [3]
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All Study Parts - observing the safety of each treatment regimen.
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Assessment method [3]
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Incidence of Adverse Events leading to dose modifications from first dose of study drug
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Timepoint [3]
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Approximately 48 months
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Secondary outcome [4]
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0
All Study Parts - observing the safety of each treatment regimen.
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Assessment method [4]
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0
Change from baseline in laboratory results
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Timepoint [4]
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Approximately 48 months
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Secondary outcome [5]
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All Study Parts - Overall Survival (OS)
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Assessment method [5]
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Time from first dose to death due to any cause
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Timepoint [5]
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Approximately 48 months
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Secondary outcome [6]
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All Study Parts - Objective Response Rate (ORR)
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Assessment method [6]
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Percentage of subjects who achieved documented complete response (CR) + confirmed partial response (PR) based on modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
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Timepoint [6]
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Approximately 48 months
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Secondary outcome [7]
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All Study Parts - Disease Control Rate (DCR)
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Assessment method [7]
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Percentage of subjects who achieved CR + PR + stable disease (SD) at 16 weeks
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Timepoint [7]
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Approximately 48 months
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Secondary outcome [8]
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All Study Parts - Time to response (TTR)
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Assessment method [8]
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Time from first dose to first documented response based on modified Response Evaluation Criteria in Solid Tumors Version 1.1
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Timepoint [8]
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Approximately 48 months
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Secondary outcome [9]
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All Study Parts - Duration of Response (DOR)
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Assessment method [9]
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Time from first response (CR or PR) to the date of progression or death from any cause, whichever occurs first
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Timepoint [9]
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Approximately 48 months
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Secondary outcome [10]
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Part 2 Only - European Organisation for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-30)
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Assessment method [10]
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Change in individual scores in patients with locally advanced, unresectable, or metastatic GIST treated with CGT9486 in combination with sunitinib compared with patients treated with sunitinib monotherapy. The scale comprises 30 questions, 24 of which are aggregated into 9 multi-item scales, to include 5 functioning scales (physical, role, cognitive, emotional and social), 3 symptom scales (fatigue, pain and nausea/vomiting) and 1 global health status scale. The remaining 6 single-item scales assess symptoms (dyspnea, appetite loss, sleep disturbance, constipation, diarrhea and the financial impact). All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status denote a better level of functioning, while higher scores on the symptom and single-item scales indicate a higher level of symptoms.
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Timepoint [10]
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Approximately 48 months
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Eligibility
Key inclusion criteria
Key
1. 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 randomization.
2. Documented disease progression on or intolerance to imatinib
3. Subjects must have received the following treatment:
* 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
4. Have at least 1 measurable lesion according to mRECIST v1.1
5. ECOG - 0 to 2
6. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Known PDGFR driving mutations or known succinate dehydrogenase deficiency
2. Clinically significant cardiac disease
3. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug
4. Gastrointestinal abnormalities including, but not limited to, significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption
5. Any active bleeding excluding hemorrhoidal or gum bleeding
6. Seropositive for HIV 1 or 2, or positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody.
7. Active, uncontrolled, systemic bacterial, fungal, or viral infections at Screening
8. Received strong CYP3A4 inhibitors or inducers
9. Received sunitinib within 3 weeks (Part 1a, Part 1b)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/04/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/09/2026
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Actual
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Sample size
Target
426
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Sir Charles Gairdner Hospital - Nedlands
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Recruitment hospital [2]
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Bankstown-Lidcombe Hospital - Bankstown
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Recruitment postcode(s) [1]
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6009 - Nedlands
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Recruitment postcode(s) [2]
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2200 - Bankstown
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Recruitment outside Australia
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New Taipei City
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Taoyuan
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Cambridge
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Glasgow
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London
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Manchester
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United Kingdom
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Cogent Biosciences, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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 426 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 GIST and 2) evaluating 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.
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Trial website
https://clinicaltrials.gov/study/NCT05208047
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Jessica Sachs, MD
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Address
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Cogent Biosciences
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Cogent Biosciences
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Address
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Country
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Phone
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617-945-5576
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05208047