Hyperglycemia Drug InducedPhase 1NCT04253223
A Study to Determine Safety and Efficacy of (REMD-477) in Controlling Hyperglycemia Due to Copanlisib
A Phase 1 study testing REMD-477 in people with Hyperglycemia Drug Induced, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia Drug Induced
- What is being tested?
- REMD-477
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2020to 5 May 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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
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
- Conditions
- Hyperglycemia Drug Induced
- Being tested
- REMD-477
- Keywords
- hyperglycemia, lymphoma, anti-glucagon receptor antibody, glucagon receptor, Volagidemab
- Medical subject headings
- Hyperglycemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REMD-477Biological
Also called Volagidemab
REMD-477 will be administered as a subcutaneous injection for three weekly doses
| Study group | Role | What they receive |
|---|---|---|
| REMD-477 | Experimental | REMD-477 (human IgG2 anti-glucagon receptor antibody Volagidemab) will be administered as a subcutaneous injection for three weekly doses Receives: Biological: REMD-477 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase inhibitor
Measured: 22 days
Serious Adverse Events
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Measured: 22 days
Liver Function Tests (LFT) units per liter (u/L)
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Measured: 22 days
Blood Glucose measurements
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Measured: 22 days
Pulse beats per minute
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Measured: 22 days
breathing Rate breaths per minute
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Measured: 22 days
Secondary outcomes (2)
Fasting Glucose levels
Determine efficacy of REMD-477 in preventing copanlisib induced hyperglycemia
Measured: 22 days
Insulin levels
Determine efficacy of REMD-477 in preventing copanlisib induced hyperglycemia
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start7 Apr 2020
- Primary completion5 May 2021
- Study completion5 May 2021
Why it stopped: poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperglycemia Drug InducedStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Herbert Lyerly, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253223
- Sponsor's protocol ID
- Pro00102920
- Status last verified
- Jun 2021
- First submitted
- 28 Jan 2020
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04253223
- Acronym / sponsor ID
- Pro00102920
- Conditions
- Hyperglycemia Drug Induced
- Keywords
- hyperglycemia, lymphoma, anti-glucagon receptor antibody, glucagon receptor, Volagidemab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 7 Apr 2020 (actual)
- Primary completion
- 5 May 2021 (actual)
- Study completion
- 5 May 2021 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| REMD-477 | Experimental | Biological: REMD-477REMD-477 (human IgG2 anti-glucagon receptor antibody Volagidemab) will be administered as a subcutaneous injection for three weekly doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REMD-477Also: VolagidemabREMD-477 will be administered as a subcutaneous injection for three weekly doses | Biological | REMD-477 |
Primary outcome
Adverse Events
Time frame: 22 days
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase inhibitor
Serious Adverse Events
Time frame: 22 days
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
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
Blood Glucose measurements
Time frame: 22 days
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
Pulse beats per minute
Time frame: 22 days
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
breathing Rate breaths per minute
Time frame: 22 days
Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase
2 secondary outcomes
Fasting Glucose levels
Time frame: 22 days
Insulin levels
Time frame: 22 days
Results and safety
The study was stopped early (reason given: poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing REMD-477 in people with Hyperglycemia Drug Induced, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: poor accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 22 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.