HR+ Metastatic Breast CancerPhase 1NCT04197999
A Study to Determine Safety and Tolerability of GMI-1359 in Subjects With HR+ Metastatic Breast Cancer
A Phase 1 study testing GMI-1359 in people with HR+ Metastatic Breast Cancer and Breast Cancer, run by GlycoMimetics Incorporated at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HR+ Metastatic Breast Cancer, Breast Cancer, Breast Cancer Metastatic
- What is being tested?
- GMI-1359
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2019to 25 Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: A Phase 1b, Single and Multiple Dose, Open-Label Trial of Intravenous GMI-1359 in HR+ Metastatic Breast Cancer Subjects
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.
- Being tested
- GMI-1359
- Keywords
- GMI-1359, breast cancer, HR+ metastatic breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GMI-1359Drug
Injection 10 mg/mL
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: GMI-1359 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 4 months
Secondary outcomes (9)
Area under the plasma concentration-time curve [AUC0-t and AUC0-∞] of GMI-1359
Measured: Up to 16 weeks
Maximum plasma concentration [Cmax] of GMI-1359
Measured: Up to 16 weeks
Time to reach maximum plasma concentration [tmax] of GMI-1359
Measured: Up to 16 weeks
Individual estimate of the terminal elimination rate constant [Λz] of GMI-1359
Measured: Up to 16 weeks
Half-life [t1/2] of GMI-1359
Measured: Up to 16 weeks
Total plasma clearance [CL] of GMI-1359
Measured: Up to 16 weeks
Apparent volume of distribution estimated at the terminal phase [Vz] of GMI-1359
Measured: Up to 16 weeks
Pre- and post-dose circulating tumor cells (CTC) enumeration to determine tumor cell mobilization [digital pathology assay]
Measured: Up to 16 weeks
Pre-and post-dose CD34+ cell quantification to determine mobilization into peripheral blood [standard flow cytometry]
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start21 Nov 2019
- Primary completion25 Aug 2021
- Study completion25 Aug 2021
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HR+ Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlycoMimetics Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeremy Force, DO, Principal investigator, Duke UniversityDorothy A Sipkins, MD, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197999
- Sponsor's protocol ID
- GMI-1359-210
- Status last verified
- Mar 2022
- First submitted
- 4 Dec 2019
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Single and Multiple Dose, Open-Label Trial of Intravenous GMI-1359 in HR+ Metastatic Breast Cancer Subjects
- ClinicalTrials.gov ID
- NCT04197999
- Acronym / sponsor ID
- GMI-1359-210
- Keywords
- GMI-1359, breast cancer, HR+ metastatic breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- GlycoMimetics IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 25 Aug 2021 (actual)
- Study completion
- 25 Aug 2021 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose followed by Multiple Doses | Experimental | Drug: GMI-1359Up to 3 single ascending doses of GMI-1359 followed by the highest tolerated dose given for 3 consecutive days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GMI-1359Injection 10 mg/mL | Drug | Single Ascending Dose followed by Multiple Doses |
Primary outcome
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
9 secondary outcomes
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
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy Force, DO principal investigator
Duke University
Dorothy A Sipkins, MD, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GMI-1359 in people with HR+ Metastatic Breast Cancer and Breast Cancer, run by GlycoMimetics Incorporated at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.