Clinical Trials /

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

NCT04197999

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: GMI-1359-210
  • NCT ID: NCT04197999

Conditions

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

Interventions

DrugSynonymsArms
GMI-1359Single Ascending Dose followed by Multiple Doses

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Single Ascending Dose followed by Multiple DosesExperimentalUp to 3 single ascending doses of GMI-1359 followed by the highest tolerated dose given for 3 consecutive days.
  • GMI-1359

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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)
Time Frame:Up to 4 months
Safety Issue:
Description:

Secondary Outcome Measures

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

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:GlycoMimetics Incorporated

Trial Keywords

  • GMI-1359
  • breast cancer
  • HR+ metastatic breast cancer

Last Updated

December 11, 2019