Comparing Velzatinib with Imatinib for gastrointestinal stromal neoplasms

Exclusion

• −Has known allergy or hypersensitivity to velzatinib or imatinib, in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → or medical monitor, contraindicates participation in the study.
• −Has documented evidence of plasma HIV-1 ribonucleic acid (RNA) ≥50 c/mL within 3 months prior to or at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →. In the 3 to 12 months prior to screening, plasma HIV 1 RNA levels consistently \<50 c/mL are required for enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →; if multiple instances of plasma HIV-1 RNA values ≥50 c/mL occurred in the 3 to 12 months prior to screening, the participant is not eligible for enrollment unless, per the investigator's assessment, the elevations were neither persistent nor associated with antiretroviral resistance; OR
• −Has untreated brain or Central nervous system (CNS) metastases or brain/CNS metastases that have progressed \[e.g., evidence of new or enlarging brain metastasis or new neurologic symptoms attributable to brain/CNS metastases\]. Participants with previously treated and clinically stable brain/CNS metastases and who have completed all corticosteroid therapy for ≥2 weeks before randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → are not excluded from participation
• −Has a known Human immunodeficiency virus (HIV) infection and meets at least one of the following criteria:
• −Has a history of HIV-associated non-Hodgkin lymphoma within 5 years prior to screening or a history of HIV-associated invasive cervical cancer; OR
• −Has received treatment with an HIV 1 immunotherapeutic vaccine within 90 days of screening.
• −Evidence of chronic hepatitis B virus (HBV) infection with detectable viral load despite antiviral therapy with high resistance barrier.
• −Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas \[e.g., breast, cervix, bladder\] that have been resected with no evidence of metastatic disease.
• −Has any clinically significant gastrointestinal abnormalities that may alter absorption, e.g., malabsorption syndrome or major resection of the stomach and/or bowels.
• −Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant. Participants with a history of autologous stem cell transplant are eligible for study participation provided the following eligibility criteriaEligibility criteriaThe full list of requirements for taking part in a study.Read more → are met: a) transplant was \[\>100 days\] prior to screening, and b) the participant has no active infection(s) at the time of screening.
• −Has a history within 6 months prior of clinically significant or uncontrolled cardiac disease, unstable angina, acute myocardial infarction, New York Heart Association Class III or IV congestive heart failure \[New York Heart Association,1994\], or clinically significant arrhythmia not controlled by standard of careStandard of careThe treatment normally given for a condition outside a study.Read more → therapy, ventricular arrhythmia, cerebrovascular accident or transient ischemic attack and uncontrolled hypertension.
• −Has ongoing adverse reactionAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more →(s) from prior therapy that has (have) not recovered to ≤Grade 1 or to the baselineBaselineYour starting measurements, taken before treatment begins.Read more → status preceding prior therapy, (excluding e.g., alopecia, hearing loss, vitiligo, endocrinopathy managed with replacement therapy, and Grade 2 neuropathy) or that the investigator, with the agreement of the sponsorSponsorThe organisation responsible for the study overall.Read more →, considers to be not clinically relevant for the tolerability of study intervention in the current clinical study.
• −Has any active renal condition (e.g., infection, requirement for dialysis, or any other significant renal condition that could affect the participant's safety).
• −Has any serious and/or unstable medical or psychiatric disorder or other condition(s) (including laboratory assessment abnormalities) that could interfere with the participant's safety, obtainment of informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →, or compliance to the study procedures.
• −Has received radiotherapy within 14 days prior to first dose of study treatment.
• −Has received any live vaccine within 30 days of randomization. Vaccination against Coronavirus disease 2019 (COVID-19) using vaccines that are authorized via the appropriate regulatory mechanisms (e.g., Emergency Use Authorization, Conditional Marketing Authorization, or Marketing Authorization Application) are not exclusionary.
• −Has received any transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including Granulocyte colony-stimulating factor \[G-CSF\], granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) within 14 days before randomization.
• −Is currently enrolled or has participated in any other clinical study involving an investigational study intervention or any other type of medical research before signing ICF.
• −Has a positive drug/alcohol screening assessment.
• −Has not had CD4 cell counts measured in the past 12 months (i.e., at least two separate measurements taken a minimum of 28 days apart, one of which must be conducted at screening); OR
• −Has had any CD4 cell count values ≤200 cells/mm3 in the past 12 months; OR
• −Has had one or more changes in their combination antiretroviral therapy regimen (except for switches as allowed per details provided in protocolProtocolThe detailed plan a study must follow.Read more →) or has received an antiretroviral therapy regimen that is inconsistent with locally recommended guidelines during the 3 months prior to screening; OR
• −Is unable to adhere to the protocol, including requirements for the Follow-up PeriodFollow-upContinued check-ins after the treatment part is finished.Read more → of the study.
• −Has an alanine aminotransferase (ALT) value \>2.5x upper limit of normal (ULN) or (for participants with documented liver metastases/tumor infiltration) has an ALT value \>5x ULN
• −Has a total bilirubin value \>1.5x ULN.
• −Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice.
• −12-lead electrocardiogram (ECG) demonstrating mean QT interval corrected (QTc) corrected by Fridericia's formula \>480msec at screening or history of long QT syndrome.
• −Is pregnant or breastfeeding.
• −Has had any major surgery (minor surgical procedures such as central venous catheter placement and tumor needle biopsy are not considered major surgical procedures) within 14 days of the first dose of study treatment or participants who have not fully recovered from surgery.