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

Sponsor
GlycoMimetics Incorporated (Industry)
Overall Status
Terminated
CT.gov ID
NCT04197999
Collaborator
(none)
4
Enrollment
1
Location
1
Arm
21.1
Actual Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1b, Single and Multiple Dose, Open-Label Trial of Intravenous GMI-1359 in HR+ Metastatic Breast Cancer Subjects
Actual Study Start Date :
Nov 21, 2019
Actual Primary Completion Date :
Aug 25, 2021
Actual Study Completion Date :
Aug 25, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: GMI-1359
Injection 10 mg/mL

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. Area under the plasma concentration-time curve [AUC0-t and AUC0-∞] of GMI-1359 [Up to 16 weeks]

  2. Maximum plasma concentration [Cmax] of GMI-1359 [Up to 16 weeks]

  3. Time to reach maximum plasma concentration [tmax] of GMI-1359 [Up to 16 weeks]

  4. Individual estimate of the terminal elimination rate constant [Λz] of GMI-1359 [Up to 16 weeks]

  5. Half-life [t1/2] of GMI-1359 [Up to 16 weeks]

  6. Total plasma clearance [CL] of GMI-1359 [Up to 16 weeks]

  7. Apparent volume of distribution estimated at the terminal phase [Vz] of GMI-1359 [Up to 16 weeks]

  8. Pre- and post-dose circulating tumor cells (CTC) enumeration to determine tumor cell mobilization [digital pathology assay] [Up to 16 weeks]

  9. Pre-and post-dose CD34+ cell quantification to determine mobilization into peripheral blood [standard flow cytometry] [Up to 16 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Medical Center Durham North Carolina United States 27710

Sponsors and Collaborators

  • GlycoMimetics Incorporated

Investigators

  • Principal Investigator: Jeremy Force, DO, Duke University
  • Principal Investigator: Dorothy A Sipkins, MD, PhD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GlycoMimetics Incorporated
ClinicalTrials.gov Identifier:
NCT04197999
Other Study ID Numbers:
  • GMI-1359-210
First Posted:
Dec 13, 2019
Last Update Posted:
Mar 22, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by GlycoMimetics Incorporated
GMI-1359
breast cancer
HR+ metastatic breast cancer
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Mar 22, 2022