A Study to Determine Safety and Tolerability of GMI-1359 in Subjects With HR+ Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04197999
• Other study ID #: GMI-1359-210
• Status: Terminated
• Phase: Phase 1
• Start date: November 21, 2019
• Est. completion date: August 25, 2021

Study information

• Verified date: March 2022
• Source: GlycoMimetics Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: August 25, 2021
• Est. primary completion date: August 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Metastatic
• Breast Neoplasms
• HR+ Metastatic Breast Cancer

Intervention

Drug:
• GMI-1359
Injection 10 mg/mL

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlycoMimetics Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		Up to 4 months
Secondary	Area under the plasma concentration-time curve [AUC0-t and AUC0-8] of GMI-1359		Up to 16 weeks
Secondary	Maximum plasma concentration [Cmax] of GMI-1359		Up to 16 weeks
Secondary	Time to reach maximum plasma concentration [tmax] of GMI-1359		Up to 16 weeks
Secondary	Individual estimate of the terminal elimination rate constant [?z] of GMI-1359		Up to 16 weeks
Secondary	Half-life [t1/2] of GMI-1359		Up to 16 weeks
Secondary	Total plasma clearance [CL] of GMI-1359		Up to 16 weeks
Secondary	Apparent volume of distribution estimated at the terminal phase [Vz] of GMI-1359		Up to 16 weeks
Secondary	Pre- and post-dose circulating tumor cells (CTC) enumeration to determine tumor cell mobilization [digital pathology assay]		Up to 16 weeks
Secondary	Pre-and post-dose CD34+ cell quantification to determine mobilization into peripheral blood [standard flow cytometry]		Up to 16 weeks