NCT05132738

Ripretinib Used for Resectable Metastatic GIST After Failure of Imatinib Therapy

Ripretinib Used for Preoperative Treatment of Potentially Resectable Locally Advanced and Recurrent Metastatic GIST After Failure of Imatinib Therapy: An Exploratory Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To explore the efficacy and safety of preoperative treatment of potentially resectable locally advanced or recurrent metastatic gastrointestinal stromal tumor (GIST) after failure of treatment.

Detailed description

This study is a single-arm, single-center, exploratory study. A total of 20 patients were enrolled. The patient was orally administered with 150 mg of ripretinib daily. The study is expected to enroll the first patient in August 2021, last patient before March 30, 2023 and end the trial in November 2023. Subjects will receive up to 6 cycles of treatment before surgery, which will occur 1 week after the last dose of study drug. The subject requires discontinuation of study treatment or withdrawal from the study due to disease progression, intolerable toxicity, or Investigator's judgment. The study will be divided into 3 periods: screening period, treatment period (visit period) and follow-up period. All subjects in the study were required to meet all inclusion criteria and exclusion criteria. In this study, the screening period did not exceed 28 days, and eligible subjects who completed the screening tests and assessments entered the treatment period for study treatment and visits as specified in the protocol. Thereafter, participants entered the follow-up period. The safety follow-up period begins with 30 days of study treatment until 90 days after dosing, and subjects should receive telephone assessments every 30 days. After the safety follow-up period, subjects entered the survival follow-up period. Survival follow-up will be performed every 3 months until 1 year after treatment. Survival information and subsequent treatment information can be collected by effective means such as telephone follow-up. For subjects without radiographic evidence of disease progression, radiographic assessments should continue to be performed at the frequency of efficacy evaluations specified for this study.

Conditions

• Gastrointestinal Stromal Tumors

Interventions

Type	Name	Description
DRUG	Ripretinib treatment	Ripretinib: 4-week (28-day) cycle of oral administration of 150 mg q.d. For patients who completed up to 6 consecutive treatment cycles in a the clinical investigator decided whether to perform the operation or not, the specific time and other matters. The above medications can be adjusted according to the adverse reactions of subjects according to the protocol at the investigator's discretion. Subjects will continue treatment until disease progression, intolerable toxicity, withdrawal of informed consent, or discontinuation of treatment as judged by the investigator, and the investigator will decide whether to perform early surgery or subsequent treatment regimen.

Timeline

• Start date: 2021-08-01
• Primary completion: 2023-11-30
• Completion: 2023-11-30
• First posted: 2021-11-24
• Last updated: 2021-11-24

Locations

1 site across 1 country: China