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A Study to Determine Safety and Efficacy of (REMD-477) in Controlling Hyperglycemia Due to Copanlisib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04253223
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : May 7, 2020
Sponsor:
Information provided by (Responsible Party):
Herbert Lyerly, Duke University

Brief Summary:
REMD-477 is a human anti-glucagon receptor antibody. Its proposed mechanism of action in controlling hyperglycemia is by blocking glucagon receptor (GCGR) signaling. In this way, it increases hepatic glucose uptake, decreases hepatic glycogenolysis and gluconeogenesis, increases glycogen synthesis, and ultimately decreases blood glucose levels. This protocol will test the hypotheses that REMD-477 is safe and tolerable in patients with severe hyperglycemia on copanlisib and that it decreases the risk of severe hyperglycemia in patients receiving copanlisib for relapsed refractory lymphoma

Condition or disease Intervention/treatment Phase
Hyperglycemia Drug Induced Biological: REMD-477 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/Ib Pilot Study to Determine the Safety and Efficacy of a Human Anti-glucagon Receptor Antibody (REMD-477) in Controlling Severe Hyperglycemia Due to Copanlisib in Patients With Relapsed or Refractory Lymphoma
Actual Study Start Date : April 7, 2020
Estimated Primary Completion Date : March 15, 2021
Estimated Study Completion Date : March 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hyperglycemia

Arm Intervention/treatment
Experimental: REMD-477
REMD-477 (human IgG2 anti-glucagon receptor antibody) will be administered as a subcutaneous injection for three weekly doses
Biological: REMD-477
REMD-477 will be administered as a subcutaneous injection for three weekly doses




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 22 days ]
    Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase inhibitor

  2. Serious Adverse Events [ Time Frame: 22 days ]
    Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase

  3. Liver Function Tests (LFT) units per liter (u/L) [ Time Frame: 22 days ]
    Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase

  4. Blood Glucose measurements [ Time Frame: 22 days ]
    Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase

  5. Pulse beats per minute [ Time Frame: 22 days ]
    Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase

  6. breathing Rate breaths per minute [ Time Frame: 22 days ]
    Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase


Secondary Outcome Measures :
  1. Fasting Glucose levels [ Time Frame: 22 days ]
    Determine efficacy of REMD-477 in preventing copanlisib induced hyperglycemia

  2. Insulin levels [ Time Frame: 22 days ]
    Determine efficacy of REMD-477 in preventing copanlisib induced hyperglycemia



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 or older
  • Relapsed or refractory lymphoma (Grade 1, 2, 3A)
  • Received 2 or more prior lines of systemic therapy for lymphoma
  • Experienced glucose >250 mg/dL after copanlisib infusion for treatment of lymphoma

Exclusion Criteria:

  • Evidence of histologic transformation
  • Follicular Lymphoma Grade 3B
  • Active CNS involvement by malignancy
  • Elevated AST or ALT > 5x ULN at Screening
  • Unmanageable sensitivity to mammalian-derived drug preparations, or to humanized or human antibodies; managed sensitivities to agents such as obinutuzumab or rituximab or similar agents are not exclusionary
  • History of drug or alcohol abuse within the last 6 months
  • History or family history of pancreatic neuroendocrine tumors or multiple endocrine neoplasia
  • History or family history of pheochromocytoma
  • Other gastrointestinal, cardiac, renal and CNS (i.e. hypoglycemia unawareness) conditions specific to diabetes that would pose additional risk to subject's safety or interfere with the study evaluation, procedures or completion in the opinion of the treating physician.
  • Female subject is pregnant or breastfeeding.

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): NCT04253223


Contacts
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Contact: Jie Wang, MD 919 668 1000 jie.wang416@duke.edu
Contact: Lauren Galentine 919-668-5579 lauren.galentine@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Jie Wang, M.D.         
Principal Investigator: Jie Wang, M.D.         
Sponsors and Collaborators
Duke University
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Responsible Party: Herbert Lyerly, Professor, Duke University
ClinicalTrials.gov Identifier: NCT04253223    
Other Study ID Numbers: Pro00102920
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Herbert Lyerly, Duke University:
hyperglycemia
lymphoma
anti-glucagon receptor antibody
glucagon receptor
Additional relevant MeSH terms:
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Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
REMD-477
Hypoglycemic Agents
Physiological Effects of Drugs