Back to resultsA Study to Determine Safety and Efficacy of (REMD-477) in Controlling Hyperglycemia Due to Copanlisib
Primary Purpose
Hyperglycemia Drug Induced
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
REMD-477
Sponsored by
About this trial
This is an interventional treatment trial for Hyperglycemia Drug Induced focused on measuring hyperglycemia, lymphoma, anti-glucagon receptor antibody, glucagon receptor, Volagidemab
Eligibility 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.
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
REMD-477
Arm Description
REMD-477 (human IgG2 anti-glucagon receptor antibody Volagidemab) will be administered as a subcutaneous injection for three weekly doses
Outcomes
Primary Outcome Measures
Adverse Events
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase inhibitor
Serious Adverse Events
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Liver Function Tests (LFT) units per liter (u/L)
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Blood Glucose measurements
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Pulse beats per minute
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
breathing Rate breaths per minute
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Secondary Outcome Measures
Fasting Glucose levels
Determine efficacy of REMD-477 in preventing copanlisib induced hyperglycemia
Insulin levels
Determine efficacy of REMD-477 in preventing copanlisib induced hyperglycemia
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04253223
Brief Title
A Study to Determine Safety and Efficacy of (REMD-477) in Controlling Hyperglycemia Due to Copanlisib
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
poor accrual
Study Start Date
April 7, 2020 (Actual)
Primary Completion Date
May 5, 2021 (Actual)
Study Completion Date
May 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
REMD-477 (Volagidemab) 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia Drug Induced
Keywords
hyperglycemia, lymphoma, anti-glucagon receptor antibody, glucagon receptor, Volagidemab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
REMD-477
Arm Type
Experimental
Arm Description
REMD-477 (human IgG2 anti-glucagon receptor antibody Volagidemab) will be administered as a subcutaneous injection for three weekly doses
Intervention Type
Biological
Intervention Name(s)
REMD-477
Other Intervention Name(s)
Volagidemab
Intervention Description
REMD-477 will be administered as a subcutaneous injection for three weekly doses
Primary Outcome Measure Information:
Title
Adverse Events
Description
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase inhibitor
Time Frame
22 days
Title
Serious Adverse Events
Description
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Time Frame
22 days
Title
Liver Function Tests (LFT) units per liter (u/L)
Description
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Time Frame
22 days
Title
Blood Glucose measurements
Description
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Time Frame
22 days
Title
Pulse beats per minute
Description
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Time Frame
22 days
Title
breathing Rate breaths per minute
Description
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Time Frame
22 days
Secondary Outcome Measure Information:
Title
Fasting Glucose levels
Description
Determine efficacy of REMD-477 in preventing copanlisib induced hyperglycemia
Time Frame
22 days
Title
Insulin levels
Description
Determine efficacy of REMD-477 in preventing copanlisib induced hyperglycemia
Time Frame
22 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Determine Safety and Efficacy of (REMD-477) in Controlling Hyperglycemia Due to Copanlisib
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