A Phase 1b, Single and Multiple Dose, Open-Label Trial of Intravenous GMI-1359 in HR+ Metastatic Breast Cancer Subjects

GlycoMimetics Incorporated1 site in 1 country4 target enrollmentNovember 21, 2019

ConditionsHR+ Metastatic Breast Cancer Breast Cancer Breast Cancer Metastatic

InterventionsGMI-1359

DrugsGMI-1359

Overview

Phase: Phase 1
Intervention: GMI-1359
Conditions: HR+ Metastatic Breast Cancer
Sponsor: GlycoMimetics Incorporated
Enrollment: 4
Locations: 1
Primary Endpoint: Occurrences of dose-limiting toxicities (DLT) including protocol-defined adverse events (AEs)/serious adverse events (SAEs), and/or laboratory abnormalities will be assessed in order to determine recommended phase II dose (Safety and Tolerability)
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This trial is being conducted to investigate the safety, tolerability, pharmacokinetics (the effect the body has on the drug), and pharmacodynamics (the effect the drug has on the body) of GMI-1359 when given with standard-of-care treatment to subjects with HR+ metastatic breast cancer.

Registry

clinicaltrials.gov

Start Date

November 21, 2019

End Date

August 25, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

GlycoMimetics Incorporated

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Pathologically confirmed HR+ metastatic breast cancer, currently stable or minimally progressive on current endocrine-based therapy.
•Continuing on current endocrine-based therapy with an aromatase inhibitor, selective estrogen receptor degrader, or selective estrogen receptor modulator; and must be medically eligible to remain on this therapy during the treatment period.

Exclusion Criteria

•Uncontrolled acute life-threatening bacterial, viral, or fungal infection.
•Subjects who are pregnant or breastfeeding
•Concurrent treatment with any cytotoxic chemotherapy agent or other targeted therapies including HER2 targeting therapies
•Currently receiving, or less than 28 days since ending treatment on another investigational drug.
•Clinically significant cardiovascular disease.
•Abnormal liver function.
•Any medical, psychiatric, or other condition which, in the opinion of the investigator, is likely to interfere with trial completion, assessments, or interpretation of trial results, or otherwise would make the subject an inappropriate subject for this trial.

Arms & Interventions

Single Ascending Dose followed by Multiple Doses

Up to 3 single ascending doses of GMI-1359 followed by the highest tolerated dose given for 3 consecutive days.

Intervention: GMI-1359

Outcomes

Primary Outcomes

Occurrences of dose-limiting toxicities (DLT) including protocol-defined adverse events (AEs)/serious adverse events (SAEs), and/or laboratory abnormalities will be assessed in order to determine recommended phase II dose (Safety and Tolerability)

Time Frame: Up to 4 months

Secondary Outcomes

Maximum plasma concentration [Cmax] of GMI-1359(Up to 16 weeks)
Total plasma clearance [CL] of GMI-1359(Up to 16 weeks)
Individual estimate of the terminal elimination rate constant [Λz] of GMI-1359(Up to 16 weeks)
Area under the plasma concentration-time curve [AUC0-t and AUC0-∞] of GMI-1359(Up to 16 weeks)
Time to reach maximum plasma concentration [tmax] of GMI-1359(Up to 16 weeks)
Half-life [t1/2] of GMI-1359(Up to 16 weeks)
Apparent volume of distribution estimated at the terminal phase [Vz] of GMI-1359(Up to 16 weeks)
Pre-and post-dose CD34+ cell quantification to determine mobilization into peripheral blood [standard flow cytometry](Up to 16 weeks)
Pre- and post-dose circulating tumor cells (CTC) enumeration to determine tumor cell mobilization [digital pathology assay](Up to 16 weeks)