- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04253223
A Study to Determine Safety and Efficacy of (REMD-477) in Controlling Hyperglycemia Due to Copanlisib
June 9, 2021 updated by: Herbert Lyerly, Duke University
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
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
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: REMD-477
REMD-477 (human IgG2 anti-glucagon receptor antibody Volagidemab) will be administered as a subcutaneous injection for three weekly doses
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REMD-477 will be administered as a subcutaneous injection for three weekly doses
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: 22 days
|
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase inhibitor
|
22 days
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Serious Adverse Events
Time Frame: 22 days
|
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
|
22 days
|
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
|
22 days
|
Blood Glucose measurements
Time Frame: 22 days
|
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
|
22 days
|
Pulse beats per minute
Time Frame: 22 days
|
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
|
22 days
|
breathing Rate breaths per minute
Time Frame: 22 days
|
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
|
22 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fasting Glucose levels
Time Frame: 22 days
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Determine efficacy of REMD-477 in preventing copanlisib induced hyperglycemia
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22 days
|
Insulin levels
Time Frame: 22 days
|
Determine efficacy of REMD-477 in preventing copanlisib induced hyperglycemia
|
22 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 7, 2020
Primary Completion (ACTUAL)
May 5, 2021
Study Completion (ACTUAL)
May 5, 2021
Study Registration Dates
First Submitted
January 28, 2020
First Submitted That Met QC Criteria
January 31, 2020
First Posted (ACTUAL)
February 5, 2020
Study Record Updates
Last Update Posted (ACTUAL)
June 11, 2021
Last Update Submitted That Met QC Criteria
June 9, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00102920
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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