Study to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in AML - Full Text View

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

MedlinePlus related topics: Acute Myeloid Leukemia Leukemia

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


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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	December 1, 2014
Last Updated:	November 8, 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

ClinicalTrials.gov processed this record on August 23, 2017