Ripretinib in Chinese Patients With Advanced GIST: a Real... | NCT05697107

Studies
Ripretinib in Chinese Patients With Advanced GIST: a Real World Study

NCT05697107

Sponsor

Peking University

Status

Unknown status

Last Update Posted

Jan 25, 2023Actual

Enrollment

308Actual

Phase

Not provided

Conditions

Gastrointestinal Stromal Tumors

Interventions

Ripretinib Oral Tablet

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 20, 2021Actual

Primary Completion Date

Aug 30, 2022Actual

Completion Date

Dec 30, 2023Estimated

First Submitted Date

Jan 15, 2023

First Submission Date that Met QC Criteria

Jan 15, 2023

First Posted Date

Jan 25, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2023

Last Update Posted Date

Jan 25, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shen Lin, Director of GI oncology Affiliation: Peking University, Peking University, Peking UniversityPrincipal Investigator

Lead Sponsor

Peking UniversityOTHER

Collaborators

Name	Class
First Affiliated Hospital, Sun Yat-Sen University	OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	OTHER
Sun Yat-sen University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

to evaluate the clinical efficacy, safety and predictive factors of ripetinib in Chinese patients with advanced GIST in the real world

Detailed Description

Ripretinib has become the standard ≥ 4L treatment in advanced GIST. Given the small sample size of patients in the China bridging study of INVICTUS as well as the short marketing time of ripretinib, further exploration on the long-term efficacy and safety of ripretinib, as well as the dominant gene mutation type of ripretinib in Chinese GIST patients is required. Hence, we plan to further explore the efficacy of ripretinib, predictors of efficacy, etc. by collecting and analyzing real-world data from Chinese patients with advanced GIST recieving ripretinib.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

308Actual

Name	Type	Description	Arm Group Labels	Other Names
Ripretinib Oral Tablet	Drug	Oral kinase inhibitor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PFS	To assess the efficacy (progression-free survival [PFS]	approximately 7 months

Secondary Outcomes

Measure	Description	Time Frame
DCR	To assess disease control rate (DCR)	approximately 6 months
OS	to assess median overall survival (mOS)	approximately 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

-≥18 years old

Histologically confirmed gastrointestinal stromal tumor (GIST)
At least one measurable lesion (mRECIST v1.1)
Received or receiving ripretinib treatment

Exclusion Criteria:

Patients who received <1 cycle of ripretinib treatment
Medical records are incomplete

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Histologically confirmed gastrointestinal stromal tumor

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lin Shen, MD	Peking University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Cancer Hospital		Beijing	Beijing Municipality	100142	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37356078	Derived	Zhang X, Zhang P, Qiu H, Fang Y, Liu H, Zhou Y, Xu H, Yu J, Zhang J, Wang M, Shen L, Li J. Large-Scale, Multicenter, Prospective Registry Study of Ripretinib in Advanced GIST: A Real-World Study from China. Adv Ther. 2023 Sep;40(9):3817-3829. doi: 10.1007/s12325-023-02576-0. Epub 2023 Jun 25.

ID	Term
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type
D009369	Neoplasms