A Study of Olverembatinib in SDH-deficient GIST.
ConditionGIST
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorAscentage Pharma Group Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Received antitumor cytotoxic chemotherapy, radiotherapy, biologic drug therapy, immunotherapy, or other investigational agents within 14 days or less than 5 times the half-life prior to the first dose.
Tyrosine kinase inhibitor (TKI) therapy within 7 days prior to the first dose.
Use of drugs that have drug interactions with the study drug within 7 days prior to the first dose.
Adverse events due to prior treatment have not recovered (> NCI CTCAE v5.0 Grade 1).
Trial design
Design model
Single group
Treatments tested in this trial
Olverembatinib
DrugOral administration with meal, QOD, every 28 days for a cycle.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: OlverembatinibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression-free survival(PFS) rate
Proportion of subjects who do not experience disease progression or death after the first dose of treatment as assessed by Independent Review Committee.
Time frame
36 monthsSecondary outcomes
1
Plasma concentrations of olverembatinib
Blood samples will be collected to measure the plasma concentration of olverembatinib.
Time frame
Cycle 2 to Cycle 3 (each cycle is 28 days)2
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
According to CTCAE v5.0, the number and frequency of adverse events of test drug were assessed.
Time frame
Through study completion,an average of 2 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ascentage Pharma Group Inc.
Lead sponsor
HealthQuest Pharma Inc.
Collaborator
Source ClinicalTrials.gov