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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02306291




Registration number
NCT02306291
Ethics application status
Date submitted
1/12/2014
Date registered
3/12/2014
Date last updated
17/05/2019

Titles & IDs
Public title
Study to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in AML
Scientific 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
Secondary ID [1] 0 0
GMI-1271-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia, Myeloid, Acute 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GMI-1271
Treatment: Drugs - Mitoxantrone
Treatment: Drugs - Etoposide
Treatment: Drugs - Cytarabine
Treatment: Drugs - Idarubicin

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


Treatment: Drugs: GMI-1271
E-selectin antagonist

Treatment: Drugs: Mitoxantrone
induction chemotherapy

Treatment: Drugs: Etoposide
induction chemotherapy

Treatment: Drugs: Cytarabine
induction chemotherapy

Treatment: Drugs: Idarubicin
induction chemotherapy

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety assessed by frequency, severity and relatedness of adverse events
Timepoint [1] 0 0
up to 44 days
Secondary outcome [1] 0 0
Time versus plasma concentration profile of GMI-1271 - Plasma concentration of GMI-1271
Timepoint [1] 0 0
up to 11 days
Secondary outcome [2] 0 0
Overall response rate - Proportion of subjects who achieve a complete response (CR) or CR with incomplete blood count recovery (CRi) per local investigator assessment
Timepoint [2] 0 0
up to 12 months
Secondary outcome [3] 0 0
Time to response - Time from date of first dose to first documentation of response
Timepoint [3] 0 0
up to 12 months
Secondary outcome [4] 0 0
Duration of response - Time from date of first documented remission to the date of relapse or death from any cause, whichever occurs first
Timepoint [4] 0 0
up to 12 months
Secondary outcome [5] 0 0
Event-free survival - Time from date of first dose to the date of treatment failure, relapse, or death from any cause, whichever occurs first
Timepoint [5] 0 0
up to 12 months
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
up to 12 months

Eligibility
Key inclusion 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) = 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Washington
Country [7] 0 0
Ireland
State/province [7] 0 0
Galway

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlycoMimetics Incorporated
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT02306291
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Daniel DeAngelo, MD, PhD
Address 0 0
Dana-Farber Cancer Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications