NCT05697107

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
308

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

1.3 years

First QC Date

January 15, 2023

Last Update Submit

January 15, 2023

Conditions

Gastrointestinal Stromal Tumors

Outcome Measures

Primary Outcomes (1)

  • PFS

    To assess the efficacy (progression-free survival \[PFS\]

    approximately 7 months

Secondary Outcomes (2)

  • DCR

    approximately 6 months

  • OS

    approximately 12 months

Interventions

Ripretinib Oral TabletDRUG

Oral kinase inhibitor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Histologically confirmed gastrointestinal stromal tumor

You may qualify if:

  • ≥18 years old
  • Histologically confirmed gastrointestinal stromal tumor (GIST)
  • At least one measurable lesion (mRECIST v1.1)
  • Received or receiving ripretinib treatment

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Related Publications (1)

  • 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.

    PMID: 37356078DERIVED

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

ripretinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • Lin Shen, MD

    Peking University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of GI oncology Affiliation: Peking University, Peking University

Study Record Dates

First Submitted

January 15, 2023

First Posted

January 25, 2023

Study Start

May 20, 2021

Primary Completion

August 30, 2022

Study Completion

December 30, 2023

Last Updated

January 25, 2023

Record last verified: 2023-01

Locations

CN(1)