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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04197999
Recruitment Status : Recruiting
First Posted : December 13, 2019
Last Update Posted : April 1, 2021
Information provided by (Responsible Party):
GlycoMimetics Incorporated

Tracking Information
First Submitted Date  ICMJE December 4, 2019
First Posted Date  ICMJE December 13, 2019
Last Update Posted Date April 1, 2021
Actual Study Start Date  ICMJE November 21, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2019)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2019)
  • Area under the plasma concentration-time curve [AUC0-t and AUC0-∞] of GMI-1359 [ Time Frame: Up to 16 weeks ]
  • Maximum plasma concentration [Cmax] of GMI-1359 [ Time Frame: Up to 16 weeks ]
  • Time to reach maximum plasma concentration [tmax] of GMI-1359 [ Time Frame: Up to 16 weeks ]
  • Individual estimate of the terminal elimination rate constant [Λz] of GMI-1359 [ Time Frame: Up to 16 weeks ]
  • Half-life [t1/2] of GMI-1359 [ Time Frame: Up to 16 weeks ]
  • Total plasma clearance [CL] of GMI-1359 [ Time Frame: Up to 16 weeks ]
  • Apparent volume of distribution estimated at the terminal phase [Vz] of GMI-1359 [ Time Frame: Up to 16 weeks ]
  • Pre- and post-dose circulating tumor cells (CTC) enumeration to determine tumor cell mobilization [digital pathology assay] [ Time Frame: Up to 16 weeks ]
  • Pre-and post-dose CD34+ cell quantification to determine mobilization into peripheral blood [standard flow cytometry] [ Time Frame: Up to 16 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Study to Determine Safety and Tolerability of GMI-1359 in Subjects With HR+ Metastatic Breast Cancer
Official Title  ICMJE A Phase 1b, Single and Multiple Dose, Open-Label Trial of Intravenous GMI-1359 in HR+ Metastatic Breast Cancer Subjects
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • HR+ Metastatic Breast Cancer
  • Breast Cancer
  • Breast Cancer Metastatic
Intervention  ICMJE Drug: GMI-1359
Injection 10 mg/mL
Study Arms  ICMJE 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.
Intervention: Drug: GMI-1359
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 11, 2019)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: GlycoMimetics, Inc. 240-243-1201
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT04197999
Other Study ID Numbers  ICMJE GMI-1359-210
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party GlycoMimetics Incorporated
Study Sponsor  ICMJE GlycoMimetics Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paul K Marcom, MD Duke University
Principal Investigator: Dorothy A Sipkins, MD, PhD Duke University
PRS Account GlycoMimetics Incorporated
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP