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NCT04330625 · ClinicalTrials.gov registry record · Phase 1
Glucagon Receptor Inhibition to Enable Breast Cancer Patients to Benefit From PI3K Inhibitor Therapy (REMD-477)
A Phase 1 study, sponsored by Duke University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT04330625 is a Phase 1 study that was terminated before completion, run by Duke University. The registered enrollment target is 1 participants.
The verdict
NCT04330625, a Phase 1 study, was terminated before completion, sponsored by Duke University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study 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 apelisib and prevent hyperglycemia associated with alpelisib in patients with advanced breast cancer who discontinue alpelisib due to severe hyperglycemia despite appropriate medical management.
Interventions
- BIOLOGICAL REMD-477
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2020-11-13 |
| Est. Completion | 2021-05-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04330625
The ClinicalTrials.gov registry entry for NCT04330625 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which REMD-477 is the first listed.
NCT04330625 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04330625 about?
NCT04330625 is a clinical study titled "Glucagon Receptor Inhibition to Enable Breast Cancer Patients to Benefit From PI3K Inhibitor Therapy (REMD-477)". 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 glycog...
What is the current status of trial NCT04330625?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2020-11-13. Estimated completion is 2021-05-05.
What interventions are being tested in trial NCT04330625?
The interventions under investigation include: REMD-477 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04330625?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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