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

Leukemia, Myeloid, Acute Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02306291
• Other study ID #: GMI-1271-201
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 2015
• Est. completion date: May 2018

Study information

• Verified date: May 2019
• Source: GlycoMimetics Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: May 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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) = 40,000/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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• GMI-1271
E-selectin antagonist
• Mitoxantrone
induction chemotherapy
• Etoposide
induction chemotherapy
• Cytarabine
induction chemotherapy
• Idarubicin
induction chemotherapy

Locations

Country	Name	City	State
Australia	Princess Alexandra Hospital	Brisbane
Ireland	University Hospital Galway	Galway
United States	University of Michigan, Ann Arbor	Ann Arbor	Michigan
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Rochester	Rochester	New York
United States	University of California, Davis Comprehensive Cancer Center	Sacramento	California
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
GlycoMimetics Incorporated

Countries where clinical trial is conducted

United States,  Australia,  Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessed by frequency, severity and relatedness of adverse events		up to 44 days
Secondary	Time versus plasma concentration profile of GMI-1271	Plasma concentration of GMI-1271	up to 11 days
Secondary	Overall response rate	Proportion of subjects who achieve a complete response (CR) or CR with incomplete blood count recovery (CRi) per local investigator assessment	up to 12 months
Secondary	Time to response	Time from date of first dose to first documentation of response	up to 12 months
Secondary	Duration of response	Time from date of first documented remission to the date of relapse or death from any cause, whichever occurs first	up to 12 months
Secondary	Event-free survival	Time from date of first dose to the date of treatment failure, relapse, or death from any cause, whichever occurs first	up to 12 months
Secondary	Overall survival	The probability of survival at 6 months (Phase 1) and 12 months (Phase 2), after the date of first dose of study drug	up to 12 months