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
Status: Completed
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
University of California, Davis Comprehensive Cancer Center
Sacramento
Massachusetts
Dana Farber Cancer Institute
Boston
Michigan
University of Michigan, Ann Arbor
Ann Arbor
New York
University of Rochester
Rochester
Ohio
Cleveland Clinic
Cleveland
Washington
University of Washington
Seattle
Other Locations
Australia
Princess Alexandra Hospital
Brisbane
Ireland
University Hospital Galway
Galway
Time Frame
Start Date: 2015-03
Completion Date: 2018-05
Participants
Target number of participants: 91
Treatments
Experimental: Arm A (Phase I)
GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older
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
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
Authors
Related Therapeutic Areas
Sponsors
Leads: GlycoMimetics Incorporated