Clinical trial NCT04197999: A Study to Determine Safety and Tolerability of GMI-1359 in Subjects With HR+ Metastatic Breast Cancer
Official title: A Phase 1b, Single and Multiple Dose, Open-Label Trial of Intravenous GMI-1359 in HR+ Metastatic Breast Cancer Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: HR+ Metastatic Breast Cancer
Breast Cancer
Breast Cancer Metastatic
Keywords: GMI-1359
breast cancer
HR+ metastatic breast cancer
Lead sponsor: GlycoMimetics Incorporated
Sponsor class: INDUSTRY
First posted: 2019-12-13
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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)
timeFrame: Up to 4 months
Secondary outcomes:
measure: Area under the plasma concentration-time curve [AUC0-t and AUC0-∞] of GMI-1359
timeFrame: Up to 16 weeks
measure: Maximum plasma concentration [Cmax] of GMI-1359
timeFrame: Up to 16 weeks
measure: Time to reach maximum plasma concentration [tmax] of GMI-1359
timeFrame: Up to 16 weeks
measure: Individual estimate of the terminal elimination rate constant [Λz] of GMI-1359
timeFrame: Up to 16 weeks
measure: Half-life [t1/2] of GMI-1359
timeFrame: Up to 16 weeks
measure: Total plasma clearance [CL] of GMI-1359
timeFrame: Up to 16 weeks
measure: Apparent volume of distribution estimated at the terminal phase [Vz] of GMI-1359
timeFrame: Up to 16 weeks
measure: Pre- and post-dose circulating tumor cells (CTC) enumeration to determine tumor cell mobilization [digital pathology assay]
timeFrame: Up to 16 weeks
measure: Pre-and post-dose CD34+ cell quantification to determine mobilization into peripheral blood [standard flow cytometry]
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Jeremy Force, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Dorothy A Sipkins, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: