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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05245968
Registration number
NCT05245968
Ethics application status
Date submitted
17/01/2022
Date registered
18/02/2022
Titles & IDs
Public title
A Study of Pimitespib in Combination With Imatinib in Patients With GIST (CHAPTER-GIST-101)
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Scientific title
A Phase 1 Study of TAS-116 (Pimitespib) in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumor
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Secondary ID [1]
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10058060
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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:
Gastrointestinal Stromal Tumors
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Condition category
Condition code
Cancer
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Stomach
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Cancer
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Bowel - Small bowel (duodenum and ileum)
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Cancer
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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 - Pimitespib
Treatment: Drugs - Imatinib
Treatment: Drugs - Sunitinib
Experimental: Dose Escalation Part - Pimitespib in combination with imatinib
Experimental: Expansion Part-A - Pimitespib in combination with imatinib
Experimental: Expansion Part-B - Pimitespib followed by imatinib
Experimental: Expansion Part-C - Sunitinib
Treatment: Drugs: Pimitespib
Pimitespib will be administered orally in 5 consecutive days followed by 2 days off treatment (QD 5) on an empty stomach at least 1 hour before or 2 hours after a meal. The doses in the Dose Escalation Part will be 80, 120 (starting dose), and 160 mg. The doses used in Arm A will be MTD or recommended dose (RD) based on the information, including the safety and the pharmacokinetics (PK) data in the Dose Escalation Part. In Expansion Part-B, pimitespib will be administered with the starting dose of 160 mg daily.
Treatment: Drugs: Imatinib
Imatinib will be administered orally, after a meal and large glass of water QD. The doses in Dose Escalation Part will be 400 mg or 300 mg (De-escalation). The doses used in Expansion Part-A will be MTD or RD based on information, including the safety and PK data in the Dose Escalation Part. In Expansion Part-B, imatinib will be administered post after pimitespib discontinuation with the starting dose of 400 mg daily.
Treatment: Drugs: Sunitinib
Sunitinib will be administered orally QD with a starting dose of 50 mg, on a schedule of 4 weeks on treatment followed by 2 weeks off, and will be taken with or without a meal in Expansion Part-C.
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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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Dose-limiting toxicity (DLT) of pimitespib in combination with imatinib
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Assessment method [1]
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Timepoint [1]
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At the end of Cycle 1 (each cycle is 28 days)
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Primary outcome [2]
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Maximum tolerable dose (MTD) of pimitespib in combination with imatinib
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Assessment method [2]
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Timepoint [2]
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At the end of Cycle 1 (each cycle is 28 days)
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Primary outcome [3]
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Progression-free survival (PFS)
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Assessment method [3]
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Timepoint [3]
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approximately 2 years
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Secondary outcome [1]
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Overall survival (OS)
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Assessment method [1]
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Timepoint [1]
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approximately 2 years
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Secondary outcome [2]
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Overall response rate (ORR)
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Assessment method [2]
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Timepoint [2]
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approximately 2 years
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Secondary outcome [3]
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Disease control rate (DCR)
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Assessment method [3]
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Timepoint [3]
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approximately 2 years
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Secondary outcome [4]
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Duration of response (DoR)
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Assessment method [4]
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Timepoint [4]
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approximately 2 years
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Secondary outcome [5]
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Adverse event (AE)
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Assessment method [5]
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Timepoint [5]
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approximately 2 years
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Secondary outcome [6]
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Adverse drug reaction (ADR)
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Assessment method [6]
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Timepoint [6]
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approximately 2 years
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Secondary outcome [7]
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Maximum plasma concentration (Cmax)
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Assessment method [7]
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Timepoint [7]
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Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)
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Secondary outcome [8]
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Time to reach maximum plasma concentration (Tmax)
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Assessment method [8]
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Timepoint [8]
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Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)
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Secondary outcome [9]
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Under the plasma concentration-time curve up to the last observable concentration (AUC0-last)
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Assessment method [9]
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Timepoint [9]
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Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)
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Secondary outcome [10]
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Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)
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Assessment method [10]
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Timepoint [10]
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Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)
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Secondary outcome [11]
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?z
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Assessment method [11]
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Timepoint [11]
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Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)
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Secondary outcome [12]
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Half-life (T1/2)
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Assessment method [12]
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Timepoint [12]
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Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)
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Secondary outcome [13]
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Oral clearance (CL/F)
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Assessment method [13]
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Timepoint [13]
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Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)
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Secondary outcome [14]
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Apparent volume of distribution (Vz/F)
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Assessment method [14]
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Timepoint [14]
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Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)
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Secondary outcome [15]
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Mean residence time (MRT)
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Assessment method [15]
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Timepoint [15]
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Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)
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Secondary outcome [16]
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Accumulation ratio
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Assessment method [16]
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Timepoint [16]
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Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)
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Secondary outcome [17]
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Metabolite ratio
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Assessment method [17]
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Timepoint [17]
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Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)
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Eligibility
Key inclusion criteria
* Provided written informed consent
* Histologically confirmed GIST
* Has radiographic progression based on RECIST 1.1 during or within 6 months of the last imatinib administration at enrollment. If surgery/radiotherapy has been performed, radiographic progression based on RECIST 1.1 with imatinib must have been observed after the last surgery /radiotherapy
* Has at least one measurable lesion based on the RECIST version 1.1, except lymph nodes (not dependent on size), which should be chosen as nontarget lesions;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
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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
* Corrected visual acuity < 0.5 (using the International Visual Acuity Measurement Standard) for both eyes
* Received treatment with any other line of therapy besides imatinib for advanced GIST
* History of total gastrectomy and/or whole resection of the small intestine
* A serious illness or medical condition
* Previous or concurrent cancer that is distinct in primary disease or histology from cancer that is being evaluated in this study. However, any previous cancer curatively treated > 5 years before the enrollment can be eligible
* Pregnancy or lactation (including lactation interruption)
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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 1
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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
1/12/2021
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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
1/12/2025
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Actual
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Sample size
Target
78
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Flinders Medical Center - Adelaide
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Recruitment hospital [2]
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Alfred Health - Melbourne
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment postcode(s) [2]
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- Melbourne
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Recruitment outside Australia
Country [1]
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China
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State/province [1]
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Beijing
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Country [2]
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China
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State/province [2]
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Shanghai
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Country [3]
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Japan
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State/province [3]
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Chiba
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Country [4]
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Japan
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State/province [4]
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Hokkaido
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Country [5]
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Japan
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State/province [5]
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Kumamoto
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Country [6]
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Japan
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State/province [6]
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Osaka
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Country [7]
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Japan
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State/province [7]
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Tokyo
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Country [8]
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Singapore
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State/province [8]
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Singapore
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Country [9]
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Taiwan
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State/province [9]
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Kaohsiung
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Country [10]
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Taiwan
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State/province [10]
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Linkou
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Country [11]
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Taiwan
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State/province [11]
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Taiho Pharmaceutical Co., Ltd.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study consists of Dose escalation part and Expansion part. In Dose Escalation Part, the maximum tolerated dose of combination of pimitespib and imatinib in patients with gastrointestinal stromal tumors (GIST) who are judged to be refractory to imatinib, estimate the recommended dose, evaluate safety and pharmacokinetics, and observe the antitumor effect. Expansion part consists of 3 arms. In Arm A, the efficacy and safety will be evaluated, which of the combination of pimitespib and imatinib in patients with GIST who have failed imatinib at doses below the MTD determined in Dose Escalation Part. In Arm B, the efficacy and safety of pimitespib monotherapy will be evaluated and the therapeutic effect of imatinib administration after pimitespib will be evaluated in an exploratory manner. In Arm C, the efficacy and safety of sunitinib monotherapy will be evaluated as reference data.
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Trial website
https://clinicaltrials.gov/study/NCT05245968
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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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Taiho Pharmaceutical Co., Ltd.
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Address
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Taiho Pharmaceutical Co., Ltd.
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Country
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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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Drug Information Center
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Address
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Country
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Phone
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+81-3-3294-4527
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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)?
Yes
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What data in particular will be shared?
Taiho provides a platform for accepting researchers' requests for sharing anonymized, patient-level, analyzable datasets from articles published in peer-reviewed journals about the primary results from Taiho-sponsored interventional clinical trials in patients in which the medicine and the indication has received marketing approval from regulatory authorities in the United States, the European Union, and/or Japan on or after January 15, 2018.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
https://www.taiho.co.jp/en/science/policy/clinical_trial_information_disclosure_policy/index.html
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Available to whom?
Access to the clinical trial data is contingent upon approval of a proposed study protocol by an independent review panel and the execution of a data-sharing agreement with the researcher.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/
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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/NCT05245968