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

NCT04197999 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: GMI-1359-210
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

HR+ Metastatic Breast Cancer; Breast Cancer; Breast Cancer Metastatic

Keywords

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

Outcome Measures

Primary Outcomes (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 Outcomes (9)

• Area under the plasma concentration-time curve [AUC0-t and AUC0-∞] of GMI-1359

  Up to 16 weeks

• Maximum plasma concentration [Cmax] of GMI-1359

  Up to 16 weeks

• Time to reach maximum plasma concentration [tmax] of GMI-1359

  Up to 16 weeks

• Individual estimate of the terminal elimination rate constant [Λz] of GMI-1359

  Up to 16 weeks

• Half-life [t1/2] of GMI-1359

  Up to 16 weeks

Study Arms (1)

Single Ascending Dose followed by Multiple Doses

EXPERIMENTAL

Up to 3 single ascending doses of GMI-1359 followed by the highest tolerated dose given for 3 consecutive days.

Drug: GMI-1359

Interventions

GMI-1359 DRUG

Injection 10 mg/mL

Single Ascending Dose followed by Multiple Doses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlycoMimetics Incorporated: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jeremy Force, DO

  Duke University

  PRINCIPAL INVESTIGATOR

• Dorothy A Sipkins, MD, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 13, 2019
• Study Start: November 21, 2019
• Primary Completion: August 25, 2021
• Study Completion: August 25, 2021
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)