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Trial record 2 of 9 for:    glycomimetics

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by GlycoMimetics Incorporated
Sponsor:
Information provided by (Responsible Party):
GlycoMimetics Incorporated
ClinicalTrials.gov Identifier:
NCT02306291
First received: December 1, 2014
Last updated: March 3, 2016
Last verified: March 2016
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:


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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time versus plasma concentration profile of GMI-1271 [ Time Frame: up to 11 days ] [ Designated as safety issue: No ]
    Plasma concentration of GMI-1271

  • Overall response rate [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Time from date of first dose to first documentation of response

  • Duration of response [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: 77
Study Start Date: March 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (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)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. AML (including secondary AML) diagnosed as per WHO criteria
  2. 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) ≤ 20,000/mm
  3. 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
  4. ECOG performance status 0-2
  5. Hemodynamically stable and adequate organ function

Exclusion criteria:

  1. Acute promyelocytic leukemia
  2. Acute leukemia of ambiguous lineage (biphenotypic leukemia)
  3. Active signs or symptoms of CNS involvement by malignancy
  4. No prior G-CSF, GM-CSF or plerixafor within 14 days of study drug dosing
  5. Known history or evidence of active hepatitis A, B, or C or HIV
  6. Uncontrolled acute life threatening bacterial, viral or fungal infection
  7. Active graft versus host disease (GVHD) ≥ Grade 2 or extensive chronic GVHD requiring immunosuppressive therapy
  8. Hematopoietic stem cell transplantation ≤ 4 months of dosing
  9. 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: Shaneice Payne, CCRP    916-703-5558      
Principal Investigator: Brian Jonas, MD, PhD         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Shannon Milillo    617-632-4912      
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: Jessica Mavor    585-275-9485      
Principal Investigator: Jane Liesveld, 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: March 3, 2016
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Ireland: Health Products Regulatory Authority

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 September 26, 2016