This is a phase I/II clinical trial assessing the tolerability and efficacy of CM4620 in children and young adults with acute pancreatitis caused by asparaginase. The tolerability of CM4620 when given to patients receiving frontline chemotherapy will be determined. The effectiveness in reducing the severity of pancreatitis will be estimated.
Primary Objectives
To assess the safety of CM4620 administration in children and young adults with asparaginase associated pancreatitis (AAP).
To profile dose-limiting toxicities and responses of the patients treated in the dose-finding phase.
To estimate the efficacy of CM4620 to prevent pseudocyst or necrotizing pancreatitis in children with AAP.
Secondary Objectives
To determine the effect of CM4620 on the incidence of severe pancreatitis
To determine the effect of CM4620 on the incidence of Systemic Inflammatory Response Syndrome (SIRS).
Acute pancreatitis with elevation of amylase OR lipase ≥ 3x the upper limit of normal AND at least 1 of: abdominal pain consistent with acute pancreatitis OR imaging findings consistent with acute pancreatitis.
Receipt of any form of asparaginase within the prior 49 days.
Patient with acute lymphoblastic leukemia/ lymphoma age < 22 years receiving therapy with curative intent.
Prior episode of pancreatitis.
QTc at baseline > 450 msec.
Creatinine > 3x the upper limit of normal for age or total bilirubin >3x the upper limit for normal for age without evidence of leukemic infiltrate or hemolysis.
Receipt of another investigational agent within the prior 7 days.
Single group
CM4620
DrugIV
The number of CTCAE grade 3-5 events
Drug safety measuring the number of CTCAE grade 3-5 events
Responses to CM4620
We will evaluate the rate of pancreatic necrosis or pseudocyst formation using radiographic imaging
Effect of CM4620 measured by levels of pancreatic enzymes
Pancreatitis measured by levels of pancreatic enzymes
Effect of CM4620: Necrosis
Necrosis measured by levels of pancreatic enzymes
Effect of CM4620: Pseudocyst
Pseudocyst measured by levels of pancreatic enzymes
Effect of CM4620: Incidence of SIRS
Presence or absence of systemic inflammatory response syndrome
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St. Jude Children's Research Hospital
Lead sponsor
CalciMedica, Inc.
Collaborator
