Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Nutritional and Metabolic Diseases

Breast Neoplasms

Influenza, Human

Hyperglycemia

Metabolic Diseases

Glucose Metabolism Disorders

All Drugs and Chemicals

Gastrointestinal Agents

Hypoglycemic Agents

Antibodies

Glucagon

Immunoglobulins

Glucagon-Like Peptide 1

Volagidemab

REMD-477 (human IgG2 anti-glucagon receptor antibody Volagidemab) will be administered as a subcutaneous injection for four weekly doses

REMD-477 will be administered as a subcutaneous injection for four weekly doses

REMD-477

Susan Dent, MD

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.

Glucagon Receptor Inhibition to Enable Breast Cancer Patients to Benefit From PI3K Inhibitor Therapy (REMD-477)

A Pilot Study of Glucagon Receptor Inhibition to Enable Breast Cancer Patients to Benefit From PI3K Inhibitor Therapy (GRIP-IT PILOT)

Evaluate the safety of REMD-477 in patients with hyperglycemia due to a PI3 kinase inhibitor

Duke University

Professor

Hyperinsulinism

Breast Diseases

Skin Diseases

Insulin

Insulin, Globin Zinc

Pioglitazone

treating hyperinsulinemia and hyperglycemia with pioglitazone in patients treated with Alpelisib for metastatic breast cancer

Ayelet Shai, MD

Ayalet Shai, MD

The goal of this study is to test whether monitoring insulin levels and using pioglitazone to treat hyperglycemia and hyperinsulinemia in patients treated with Alpelisib for metastatic breast cancer is feasible and safe, and to assess the rates of glycemic control, dose reductions and treatment discontinuation and the progression free survival of patients treated with this regimen.

1. To assess the feasibility and safety of monitoring insulin levels alongside glucose levels and of directing antidiabetic treatment according to insulin and fasting glucose levels in patients treated with Alpelisib for metastatic breast cancer.
2. To assess the feasibility and safety of treatment with pioglitazone in these patients.
3. To assess the rate of severe (grade 3-4) hyperglycemia in patients treated according to this protocol.
4. To assess the rates of dose reductions and treatment discontinuation due to hyperglycemia in patients treated according to this protocol.
5. To assess the median progression free survival of patients treated according to this protocol

A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.

Rambam Health Care Campus

Head of breast cancer unit

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Glucagon Receptor Inhibition to Enable Breast Cancer Patients to Benefit From PI3K Inhibitor Therapy (REMD-477)	NCT04330625	Hyperglycemia D...	REMD-477	18 Years -	Duke University
A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.	NCT05753657	Metastatic Brea... Hyperinsulinism Hyperglycemia D...	Pioglitazone	18 Years - 85 Years	Rambam Health Care Campus
A Pilot Study of Monitoring Insulin Levels and Treating Hyperinsulinemia and Hyperglycemia With Pioglitazone in Patients Treated With Alpelisib for Metastatic Breast Cancer.	NCT05753657	Metastatic Brea... Hyperinsulinism Hyperglycemia D...	Pioglitazone	18 Years - 85 Years	Rambam Health Care Campus

Spots Global Cancer Trial Database for hyperglycemia drug induced