Study to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in AML
This study is currently recruiting participants.
Verified November 2016 by GlycoMimetics Incorporated
Sponsor:
GlycoMimetics Incorporated
ClinicalTrials.gov Identifier:
NCT02306291
First Posted: December 3, 2014
Last Update Posted: November 9, 2016
Information provided by (Responsible Party):
GlycoMimetics Incorporated
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Purpose
This study will evaluate GMI-1271, a specific E-selectin antagonist, in acute myeloid leukemia in combination with standard agents used to treat this disease.
| Condition | Intervention | Phase |
|---|---|---|
| Leukemia, Myeloid, Acute | Drug: GMI-1271 | Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | A Phase I/II, Open-label Multicenter Trial to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in Patients With Acute Myeloid Leukemia |
Resource links provided by NLM:
Genetics Home Reference related topics:
core binding factor acute myeloid leukemia
cytogenetically normal acute myeloid leukemia
familial acute myeloid leukemia with mutated CEBPA
Genetic and Rare Diseases Information Center resources:
Myeloid Leukemia
Acute Myeloid Leukemia
Acute Non Lymphoblastic Leukemia
U.S. FDA Resources
Further study details as provided by GlycoMimetics Incorporated:
Primary Outcome Measures:
- Safety assessed by frequency, severity and relatedness of adverse events [ Time Frame: up to 44 days ]
Secondary Outcome Measures:
- Time versus plasma concentration profile of GMI-1271 [ Time Frame: up to 11 days ]Plasma concentration of GMI-1271
- Overall response rate [ Time Frame: up to 12 months ]Proportion of subjects who achieve a complete response (CR) or CR with incomplete blood count recovery (CRi) per local investigator assessment
- Time to response [ Time Frame: up to 12 months ]Time from date of first dose to first documentation of response
- Duration of response [ Time Frame: up to 12 months ]Time from date of first documented remission to the date of relapse or death from any cause, whichever occurs first
- Event-free survival [ Time Frame: up to 12 months ]Time from date of first dose to the date of treatment failure, relapse, or death from any cause, whichever occurs first
- Overall survival [ Time Frame: up to 12 months ]The probability of survival at 6 months (Phase 1) and 12 months (Phase 2), after the date of first dose of study drug
| Estimated Enrollment: | 102 |
| Study Start Date: | March 2015 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm A (Phase I)
GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older
|
Drug: GMI-1271
Dose escalation
|
|
Experimental: Arm B (Phase II Arm A)
GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older
|
Drug: GMI-1271
Dose expansion
|
|
Experimental: Arm C (Phase II Arm B)
GMI-1271 in combination with cytarabine and idarubicin (7+3 regimen) in newly diagnosed subjects 60 years and older
|
Drug: GMI-1271
Safety run-in then dose expansion
|
Eligibility
Information from the National Library of Medicine
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, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- AML (including secondary AML) diagnosed as per WHO criteria
-
For relapsed/refractory subjects only:
- Subjects age ≥ 18 years with relapsed or refractory AML after ≤ 2 prior induction regimens, at least one containing anthracyclines
- Medically eligible to receive MEC
- Absolute blast count (ABC) ≤ 40,000/mm
-
For treatment-naïve subjects only:
- Subjects ≥ 60 years of age with newly diagnosed AML
- Medically eligible to receive "7+3" cytarabine/idarubicin
- ABC count ≤ 40,000/mm
- ECOG performance status 0-2
- Hemodynamically stable and adequate organ function
Exclusion criteria:
- Acute promyelocytic leukemia
- Acute leukemia of ambiguous lineage (biphenotypic leukemia)
- Active signs or symptoms of CNS involvement by malignancy
- No prior G-CSF, GM-CSF or plerixafor within 14 days of study drug dosing
- Known history or evidence of active hepatitis A, B, or C or HIV
- Uncontrolled acute life threatening bacterial, viral or fungal infection
- Active graft versus host disease (GVHD) ≥ Grade 2 or extensive chronic GVHD requiring immunosuppressive therapy
- Hematopoietic stem cell transplantation ≤ 4 months of dosing
- Clinically significant cardiovascular disease
Contacts and Locations
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): NCT02306291
Contacts
| Contact: GlycoMimetics, Inc. | clinicaltrials@glycomimetics.com |
Locations
| United States, California | |
| University of California, Davis Comprehensive Cancer Center | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Brenda Martineau 916-734-0188 | |
| Principal Investigator: Brian Jonas, MD, PhD | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Caroline Kokulis 617-632-6288 | |
| Principal Investigator: Daniel DeAngelo, MD, PhD | |
| United States, Michigan | |
| University of Michigan, Ann Arbor | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Cancer Answer Line 800-865-1125 | |
| Principal Investigator: Dale Bixby, MD | |
| United States, New York | |
| University of Rochester | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Shawna Worth 585-273-2114 | |
| Principal Investigator: Jane Liesveld, MD | |
| United States, Ohio | |
| Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Contact: Christopher Goebel 216-444-9445 | |
| Principal Investigator: Anjali Advani, MD | |
| United States, Washington | |
| University of Washington | Recruiting |
| Seattle, Washington, United States, 98109 | |
| Contact: Cody Hammer 206-288-1286 | |
| Principal Investigator: Pamela Becker, MD, PhD | |
| Australia | |
| Princess Alexandra Hospital | Recruiting |
| Brisbane, Australia | |
| Contact: Jason Kelly +617 3176 6826 | |
| Principal Investigator: Paula Marlton, MD | |
| Ireland | |
| University Hospital Galway | Recruiting |
| Galway, Ireland | |
| Contact: Veronica McInerney 353 91 49 4031 | |
| Principal Investigator: Michael O'Dwyer, MD | |
Sponsors and Collaborators
GlycoMimetics Incorporated
Investigators
| Principal Investigator: | Daniel DeAngelo, MD, PhD | Dana-Farber Cancer Institute |
More Information
| Responsible Party: | GlycoMimetics Incorporated |
| ClinicalTrials.gov Identifier: | NCT02306291 History of Changes |
| Other Study ID Numbers: |
GMI-1271-201 |
| First Submitted: | December 1, 2014 |
| First Posted: | December 3, 2014 |
| Last Update Posted: | November 9, 2016 |
| Last Verified: | November 2016 |
Keywords provided by GlycoMimetics Incorporated:
|
AML Acute myeloid leukemia E-selectin |
relapse refractory elderly newly diagnosed induction |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type Neoplasms |