TRIAL DETAIL

A Study of Olverembatinib in SDH-deficient GIST. (POLARIS-3)

Drug:
Trial Name:
A Study of Olverembatinib in SDH-deficient GIST. (POLARIS-3)
NCT#:
Conditions:
Gastrointestinal Stromal Tumor
Status:
Recruiting
Phase:
3
Start Date 10/31/2024
Age of Trial (yrs) .4
Treatment Phase:
Gleevec-resistant
Drug Category:
SDH-directed
Strategy:
Block KIT
Trial Type:
Specifically GIST and only GIST
Other Protocol IDs:
HQP1351GG301 POLARIS-3
Sponsor:
Ascentage Pharma Group Inc.
Patient Contact:
Yifan Zhai, M.D., Ph.D. +86-20-28068501 yzhai@ascentage.com
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral
Trial Notes:
Brief Summary

An international multicenter, open, single-arm pivotal registration phase III study to determine the efficacy and safety of olverembatinib in patients with SDH-deficient gastrointestinal stromal tumor (GIST) who have previously been treated with one-line therapy, and to evaluate the progression-free survival and clinical benefit rate of olverembatinib in patients with SDH-deficient GIST.

Detailed Description
This study intends to enroll patients with SDH-deficient GIST who have failed at least one systemic therapy to receive olverembatinib tablets 40mg orally administered with meals once every other day and every 28 days for a dosing cycle.

Partial Eligibility Criteria (See NCT listing for full criteria)

Inclusion Criteria:

Histologically and/or cytologically confirmed GIST, immunohistochemistry with loss of SDHB expression, and failure of at least one prior systemic therapy. Defined as disease progression or intolerable as judged by the investigator.
Must have at least one measurable target lesion.
ECOG≤ 2.
Expected survival of at least 3 months.

Trial Links

Trial Results
 
 

Drug Information
Preclinical development of HQP1351, a multikinase inhibitor targeting a broad spectrum of mutant KIT kinases, for the treatment of imatinib-resistant gastrointestinal stromal tumors.
 

Trial Sites

Name
Address
City
State
Zip
Country
Guangzhou
Guandong
510000
China