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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
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
Secondary ID [1] 0 0
CGT9486-21-301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Gastrointestinal Stromal Tumors 0 0
Metastatic Cancer 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 - CGT9486 plus sunitinib
Treatment: Drugs - CGT9486
Treatment: Drugs - Sunitinib
Treatment: Drugs - Sunitinib
Treatment: Drugs - Midazolam
Treatment: Drugs - CGT9486 plus 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

Experimental: DDI Substudy (Midazolam) - Midazolam, CGT9486, sunitinib


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.

Treatment: Drugs: Midazolam
Participants will receive a single-dose of midazolam on Day 1 and Day 16

Treatment: Drugs: CGT9486 plus sunitinib
Patients will receive CGT9486 orally starting on Day 2 and sunitinib starting on Day 16 until study stopping rules are met.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1a - pharmacokinetics - Cmax
Timepoint [1] 0 0
16 days
Primary outcome [2] 0 0
Part 1a - pharmacokinetics - AUC
Timepoint [2] 0 0
16 days
Primary outcome [3] 0 0
Part 1b - pharmacokinetics - Cmax
Timepoint [3] 0 0
14 days
Primary outcome [4] 0 0
Part 1b - pharmacokinetics - AUC
Timepoint [4] 0 0
14 days
Primary outcome [5] 0 0
Part 1b - pharmacokinetics - Tmax
Timepoint [5] 0 0
14 days
Primary outcome [6] 0 0
Part 2 - Progression Free Survival (PFS)
Timepoint [6] 0 0
Approximately 48 months
Primary outcome [7] 0 0
DDI Substudy - pharmacokinetics - AUC
Timepoint [7] 0 0
16 days
Primary outcome [8] 0 0
DDI Substudy - pharmacokinetics - Cmax
Timepoint [8] 0 0
14 days
Secondary outcome [1] 0 0
All Study Parts - observing the safety of each treatment regimen.
Timepoint [1] 0 0
Approximately 48 months
Secondary outcome [2] 0 0
All Study Parts - observing the safety of each treatment regimen.
Timepoint [2] 0 0
Approximately 48 months
Secondary outcome [3] 0 0
All Study Parts - observing the safety of each treatment regimen.
Timepoint [3] 0 0
Approximately 48 months
Secondary outcome [4] 0 0
All Study Parts - observing the safety of each treatment regimen.
Timepoint [4] 0 0
Approximately 48 months
Secondary outcome [5] 0 0
Part 1a, Part 1b, Part 2 - Overall Survival (OS)
Timepoint [5] 0 0
Approximately 48 months
Secondary outcome [6] 0 0
Part 1a, Part 1b, Part 2 - Objective Response Rate (ORR)
Timepoint [6] 0 0
Approximately 48 months
Secondary outcome [7] 0 0
Part 1a, Part 1b, Part 2 - Disease Control Rate (DCR)
Timepoint [7] 0 0
Approximately 48 months
Secondary outcome [8] 0 0
Part 1a, Part 1b. Part 2 - Time to response (TTR)
Timepoint [8] 0 0
Approximately 48 months
Secondary outcome [9] 0 0
Part 1a, Part 1b, Part 2 - Duration of Response (DOR)
Timepoint [9] 0 0
Approximately 48 months
Secondary outcome [10] 0 0
Part 2 Only - European Organisation for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-30)
Timepoint [10] 0 0
Approximately 48 months

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:

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
4. Have at least 1 measurable lesion according to mRECIST v1.1 (Part1a, Part 1b, Part 2)
5. ECOG - 0 to 2
6. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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, DDI Substudy)

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2026
Actual
Sample size
Target
442
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [2] 0 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment postcode(s) [2] 0 0
2200 - Bankstown
Recruitment outside Australia
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Alabama
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Arizona
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California
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Verona
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Taipei
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Taiwan
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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

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cogent Biosciences, Inc.
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Jessica Sachs, MD
Address 0 0
Cogent Biosciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Cogent Biosciences
Address 0 0
Country 0 0
Phone 0 0
617-945-5576
Fax 0 0
Email 0 0
peakinfo@cogentbio.com
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?

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