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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)
Scientific title
A Phase 1 Study of TAS-116 (Pimitespib) in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumor
Secondary ID [1] 0 0
10058060
Universal Trial Number (UTN)
Trial acronym
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 - 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose-limiting toxicity (DLT) of pimitespib in combination with imatinib
Timepoint [1] 0 0
At the end of Cycle 1 (each cycle is 28 days)
Primary outcome [2] 0 0
Maximum tolerable dose (MTD) of pimitespib in combination with imatinib
Timepoint [2] 0 0
At the end of Cycle 1 (each cycle is 28 days)
Primary outcome [3] 0 0
Progression-free survival (PFS)
Timepoint [3] 0 0
approximately 2 years
Secondary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
approximately 2 years
Secondary outcome [2] 0 0
Overall response rate (ORR)
Timepoint [2] 0 0
approximately 2 years
Secondary outcome [3] 0 0
Disease control rate (DCR)
Timepoint [3] 0 0
approximately 2 years
Secondary outcome [4] 0 0
Duration of response (DoR)
Timepoint [4] 0 0
approximately 2 years
Secondary outcome [5] 0 0
Adverse event (AE)
Timepoint [5] 0 0
approximately 2 years
Secondary outcome [6] 0 0
Adverse drug reaction (ADR)
Timepoint [6] 0 0
approximately 2 years
Secondary outcome [7] 0 0
Maximum plasma concentration (Cmax)
Timepoint [7] 0 0
Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)
Secondary outcome [8] 0 0
Time to reach maximum plasma concentration (Tmax)
Timepoint [8] 0 0
Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)
Secondary outcome [9] 0 0
Under the plasma concentration-time curve up to the last observable concentration (AUC0-last)
Timepoint [9] 0 0
Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)
Secondary outcome [10] 0 0
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-inf)
Timepoint [10] 0 0
Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)
Secondary outcome [11] 0 0
?z
Timepoint [11] 0 0
Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)
Secondary outcome [12] 0 0
Half-life (T1/2)
Timepoint [12] 0 0
Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)
Secondary outcome [13] 0 0
Oral clearance (CL/F)
Timepoint [13] 0 0
Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)
Secondary outcome [14] 0 0
Apparent volume of distribution (Vz/F)
Timepoint [14] 0 0
Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)
Secondary outcome [15] 0 0
Mean residence time (MRT)
Timepoint [15] 0 0
Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)
Secondary outcome [16] 0 0
Accumulation ratio
Timepoint [16] 0 0
Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)
Secondary outcome [17] 0 0
Metabolite ratio
Timepoint [17] 0 0
Multiple time points on Day 1 and Day5 or Day12 of Cycle 1 (each cycle is 28 days)

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

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 1
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
1/12/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
78
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Center - Adelaide
Recruitment hospital [2] 0 0
Alfred Health - Melbourne
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
China
State/province [2] 0 0
Shanghai
Country [3] 0 0
Japan
State/province [3] 0 0
Chiba
Country [4] 0 0
Japan
State/province [4] 0 0
Hokkaido
Country [5] 0 0
Japan
State/province [5] 0 0
Kumamoto
Country [6] 0 0
Japan
State/province [6] 0 0
Osaka
Country [7] 0 0
Japan
State/province [7] 0 0
Tokyo
Country [8] 0 0
Singapore
State/province [8] 0 0
Singapore
Country [9] 0 0
Taiwan
State/province [9] 0 0
Kaohsiung
Country [10] 0 0
Taiwan
State/province [10] 0 0
Linkou
Country [11] 0 0
Taiwan
State/province [11] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Taiho Pharmaceutical Co., Ltd.
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Taiho Pharmaceutical Co., Ltd.
Address 0 0
Taiho Pharmaceutical Co., Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Drug Information Center
Address 0 0
Country 0 0
Phone 0 0
+81-3-3294-4527
Fax 0 0
Email 0 0
n-arimura@taiho.co.jp
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
When will data be available (start and end dates)?
https://www.taiho.co.jp/en/science/policy/clinical_trial_information_disclosure_policy/index.html
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


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