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Trial record 1 of 1 for:    ST JUDES | Acute Pancreatitis | United States
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Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase

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ClinicalTrials.gov Identifier: NCT04195347
Recruitment Status : Recruiting
First Posted : December 11, 2019
Last Update Posted : April 19, 2022
Sponsor:
Collaborator:
CalciMedica, Inc.
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Acute Pancreatitis Drug: CM4620 Phase 1 Phase 2

Detailed Description:

This is an open label safety and efficacy evaluation with comparison of toxicity to a historical control population (TOTXVI).There will be 3 cohorts of patients enrolled, and the dose for each cohort will be determined based on the toxicities experienced in the ongoing and prior cohorts.

An initial 9 patients (cohort 1) will be enrolled and will receive dose level 1 and monitored for toxicity. If the therapy is well tolerated, 6 patients (cohort 2) will be treated at dose level 2. Subsequent enrollment of 9 patients (cohort 3) will be at either dose level 1 or 2 based on tolerability. The keyboard design will be used to determine the dosing for cohorts 2 and 3. Additional patients will be enrolled at the recommended phase II dose (RP2D) until a total of 24 patients have been treated at that dose, including any treated during the dose-finding phase.

CM4620 will be given days 1-4 as an IV infusion beginning within 36 hours of the onset of acute pancreatitis associated abdominal pain and within 8 hours of enrollment. For patients with prior abdominal pain or in those unable to communicate the location/characteristic of their pain, a change in the characteristic of the pain or new enzyme elevation/imaging findings after previously normal studies will determine the timing of onset of pancreatitis.

Patients will be followed for about 4 months after treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CRSPA: Phase I/II Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase
Actual Study Start Date : September 4, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : December 2023


Arm Intervention/treatment
Experimental: CM4620 Treatment

Phase I:

Cohort 1 patients receive CM4620 IV at dose level 1 on days 1-4. Cohort 2 patients receive CM4620 IV at dose level 2 on days 1-4. Cohort 3 patients receive CM4620 IV at either dose level 1 or 2 on days 1-4

Phase II:

Patients will receive CM4620 IV on days 1-4 at the recommended Phase II dose (RP2D) as determined in Phase I.

Drug: CM4620
IV
Other Name: CM4620-IE




Primary Outcome Measures :
  1. The number of CTCAE grade 3-5 events [ Time Frame: Within 28 days of receiving the medication ]
    Drug safety measuring the number of CTCAE grade 3-5 events

  2. Responses to CM4620 [ Time Frame: 28-35 days after study entry. ]
    We will evaluate the rate of pancreatic necrosis or pseudocyst formation using radiographic imaging


Secondary Outcome Measures :
  1. Effect of CM4620 measured by levels of pancreatic enzymes [ Time Frame: 72 hours after study entry ]
    Pancreatitis measured by levels of pancreatic enzymes

  2. Effect of CM4620: Necrosis [ Time Frame: 28-35 days from study entry ]
    Necrosis measured by levels of pancreatic enzymes

  3. Effect of CM4620: Pseudocyst [ Time Frame: 28-35 days from study entry ]
    Pseudocyst measured by levels of pancreatic enzymes

  4. Effect of CM4620: Incidence of SIRS [ Time Frame: 48-72 hours after study entry ]
    Presence or absence of systemic inflammatory response syndrome



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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 35 days.
  • Patient with acute lymphoblastic leukemia/ lymphoma age < 22 years receiving therapy with curative intent on either TOT17 or non-protocol therapy plan "as per" TOTXVI or TOT17.

Exclusion Criteria:

  • Prior episode of pancreatitis.
  • QTc at baseline > 450 msec.
  • Creatinine or total bilirubin > 3x the upper limit of normal for age.
  • Receipt of another investigational agent within the prior 7 days.
  • History of allergy to eggs or known hypersensitivity to any component of CM4620.
  • Positive pregnancy test or breastfeeding. Females of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment. Males and females of childbearing potential must agree to use effective contraception for at least twelve months following the completion of therapy.
  • Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04195347


Contacts
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Contact: Seth E. Karol, MD 866-278-5833 referralinfo@stjude.org

Locations
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United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Seth E. Karol, MD    866-278-5833    referralinfo@stjude.org   
Principal Investigator: Seth E. Karol, MD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
CalciMedica, Inc.
Investigators
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Principal Investigator: Seth E. Karol, MD St. Jude Children's Research Hospital
Additional Information:
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Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT04195347    
Other Study ID Numbers: CRSPA
NCI-2019-08205 ( Registry Identifier: NCI Clinical Trial Registration Program )
First Posted: December 11, 2019    Key Record Dates
Last Update Posted: April 19, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will be made available at the time of article publication.
Access Criteria: Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Jude Children's Research Hospital:
Acute Pancreatitis
Asparaginase
Asparaginase Associated Pancreatitis
Acute Lymphoblastic Leukemia
Acute Lymphoblastic Lymphoma
CM4620
Children
SIRS
Systemic Inflammatory Response
Young Adults
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases