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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.
 
ClinicalTrials.gov Identifier: NCT04197999
Recruitment Status : Recruiting
First Posted : December 13, 2019
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
GlycoMimetics Incorporated

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
HR+ Metastatic Breast Cancer Breast Cancer Breast Cancer Metastatic Drug: GMI-1359 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
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 : November 21, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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




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) [ Time Frame: Up to 4 months ]

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04197999


Contacts
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Contact: GlycoMimetics, Inc. 240-243-1201 clinicaltrials@glycomimetics.com

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: Paul K Marcom, MD         
Principal Investigator: Dorothy A Sipkins, MD, PhD         
Sponsors and Collaborators
GlycoMimetics Incorporated
Investigators
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Principal Investigator: Paul K Marcom, MD Duke University
Principal Investigator: Dorothy A Sipkins, MD, PhD Duke University

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Responsible Party: GlycoMimetics Incorporated
ClinicalTrials.gov Identifier: NCT04197999    
Other Study ID Numbers: GMI-1359-210
First Posted: December 13, 2019    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases