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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04197999 |
Recruitment Status :
Terminated
(After demonstrating the on target effect of GMI-1359 via pharmacodynamic markers (CXCR4 and E-selectin), Sponsor terminated the trial due to COVID-related slow enrollment.)
First Posted : December 13, 2019
Last Update Posted : March 22, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HR+ Metastatic Breast Cancer Breast Cancer Breast Cancer Metastatic | Drug: GMI-1359 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
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 : | November 21, 2019 |
Actual Primary Completion Date : | August 25, 2021 |
Actual Study Completion Date : | August 25, 2021 |
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 |
- 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 ]
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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.
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
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Jeremy Force, DO | Duke University | |
Principal Investigator: | Dorothy A Sipkins, MD, PhD | Duke University |
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: | March 22, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
GMI-1359 breast cancer HR+ metastatic breast cancer |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |