A Legacy Study in Participants With Gastrointestinal Stromal Tumors (GIST)
ConditionGastrointestinal Neoplasms
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGlaxoSmithKline
About this trial
This study aims to evaluate the long-term safety and tolerability of velzatinib (GSK6042981) in adults with GIST who have previously received velzatinib in parent study and continue to benefit from the treatment. Participants will be monitored for side effects and overall health to better understand the effects of long-term treatment and support future care for adults with GIST.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant is currently receiving treatment with velzatinib for gastrointestinal stromal tumors in a velzatinib parent study that has fulfilled the requirement for the primary objective.
Participant is benefiting from treatment with velzatinib as assessed by the investigator.
Participant can understand the study procedures and will agree to participate in the study by providing written informed consent.
Participant is willing and able to comply with scheduled visit assessments, treatment plans, and any other study procedures.
Disqualifiers
Participant has permanently discontinued velzatinib treatment in a velzatinib parent study for any reason.
Participant has received any other systemic anticancer therapy between last dose on the parent study and entering this study.
Any laboratory abnormality or clinically significant adverse event that, in the opinion of the investigator, represents a clinically significant risk to the participant if enrolled.
Participant is pregnant or breastfeeding.
Trial design
Design model
Single group
Treatments tested in this trial
Velzatinib
DrugVelzatinib will be administered.
Treatment groups
72 Participants
are divided into 1 treatment groupGroup A: VelzatinibExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame
Up to 224 weeks2
Duration of TEAEs and SAEs
Time frame
Up to 224 weeks3
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) by severity
Time frame
Up to 224 weeks4
Number of participants with adverse events or serious adverse events leading to dose modification or study intervention discontinuation
Time frame
Up to 224 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: