Study to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in AML
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02306291 |
|
Recruitment Status :
Active, not recruiting
First Posted : December 3, 2014
Last Update Posted : August 8, 2018
|
Sponsor:
GlycoMimetics Incorporated
Information provided by (Responsible Party):
GlycoMimetics Incorporated
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Leukemia, Myeloid, Acute | Drug: GMI-1271 Drug: Mitoxantrone Drug: Etoposide Drug: Cytarabine Drug: Idarubicin | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 91 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential 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 |
| Actual Study Start Date : | March 2015 |
| Actual Primary Completion Date : | December 2017 |
| Estimated Study Completion Date : | December 2018 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Core binding factor acute myeloid leukemia
Cytogenetically normal acute myeloid leukemia
Familial acute myeloid leukemia with mutated CEBPA
| Arm | Intervention/treatment |
|---|---|
|
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
E-selectin antagonist
Other Name: Uproleselan Drug: Mitoxantrone induction chemotherapy Drug: Etoposide induction chemotherapy Drug: Cytarabine induction chemotherapy |
|
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
E-selectin antagonist
Other Name: Uproleselan Drug: Mitoxantrone induction chemotherapy Drug: Etoposide induction chemotherapy Drug: Cytarabine induction chemotherapy |
|
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
E-selectin antagonist
Other Name: Uproleselan Drug: Cytarabine induction chemotherapy Drug: Idarubicin induction chemotherapy |
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
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02306291
Locations
| United States, California | |
| University of California, Davis Comprehensive Cancer Center | |
| Sacramento, California, United States, 95817 | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| University of Michigan, Ann Arbor | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, New York | |
| University of Rochester | |
| Rochester, New York, United States, 14642 | |
| United States, Ohio | |
| Cleveland Clinic | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Washington | |
| University of Washington | |
| Seattle, Washington, United States, 98109 | |
| Australia | |
| Princess Alexandra Hospital | |
| Brisbane, Australia | |
| Ireland | |
| University Hospital Galway | |
| Galway, Ireland | |
Sponsors and Collaborators
GlycoMimetics Incorporated
Investigators
| Principal Investigator: | Daniel DeAngelo, MD, PhD | Dana-Farber Cancer Institute |
| Responsible Party: | GlycoMimetics Incorporated |
| ClinicalTrials.gov Identifier: | NCT02306291 History of Changes |
| Other Study ID Numbers: |
GMI-1271-201 |
| First Posted: | December 3, 2014 Key Record Dates |
| Last Update Posted: | August 8, 2018 |
| Last Verified: | August 2018 |
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 Etoposide Mitoxantrone Idarubicin Etoposide phosphate Cytarabine Antineoplastic Agents, Phytogenic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antimetabolites Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Antibiotics, Antineoplastic |