Back to resultsStudy of ENMD-2076 in Patients With Relapsed or Refractory Hematological Malignancies
Primary Purpose
Relapsed or Refractory Hematological Malignancies
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
ENMD-2076
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed or Refractory Hematological Malignancies focused on measuring Leukemia, Hematologic neoplasms
Eligibility Criteria
Inclusion Criteria:
- Patients must have relapsed/refractory hematological malignancy for which no standard therapies are anticipated to result in a durable remission. Patients with poor-risk myelodysplasia (MDS) [i.e., IPSS ≥ 1.5] or chronic myelomonocytic leukemia (CMML) are also candidates for this protocol. Relapsed/refractory leukemias include acute non lymphocytic leukemia (AML) by WHO classification, acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), or chronic myelogenous leukemia (CML) in blast crisis. Patients with agnogenic myeloid metaplasia (AMM) are also eligible. Patients with relapsed or refractory lymphoma or myeloma may also participate.
- Age ≥18 years.
- Adequate performance status
- Interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for noncytotoxic agents and adequate recovery from prior toxicities. If the patient had a transplant, at least 6 months must have passed before initiation of treatment on this protocol and stable graft versus host disease (no change in severity) for 4 weeks preceding study entry (if applicable).
- Persistent clinically significant chronic toxicities from prior therapy must have resolved to baseline or NCI CTCAE Grade < 1
- Adequate laboratory results within 10 days of ENMD-2076 administration (unless the abnormality is considered attributable to leukemia)
Exclusion Criteria:
- Pregnant or breast-feeding women.
- Clinical evidence of bowel obstruction, active uncontrolled malabsorption syndromes or a history of total gastrectomy.
- Impaired cardiac function including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, uncontrolled hypertension, or uncontrolled congestive heart failure. Blood pressure must be < 150/90 at the time of enrollment.
- Receiving any other treatment for their disease
- QTc prolongation defined as ≥ 470 ms.
Sites / Locations
- Princess Margaret Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Define the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of oral daily ENMD 2076 by evaluation of adverse events
Secondary Outcome Measures
Safety and toxicity of repeated oral dosing of ENMD 2076
Describe any preliminary evidence of anti-cancer effects of ENMD-2076 in patients with hematological malignancies
Full Information
NCT ID
NCT00904787
First Posted
May 19, 2009
Last Updated
August 3, 2011
Sponsor
CASI Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00904787
Brief Title
Study of ENMD-2076 in Patients With Relapsed or Refractory Hematological Malignancies
Official Title
A Phase 1 Study of ENMD-2076 in Patients With Relapsed or Refractory Hematological Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
CASI Pharmaceuticals, Inc.
4. Oversight
5. Study Description
Brief Summary
To define the maximum tolerated dose of oral daily ENMD 2076 in patients with relapsed or refractory hematological malignancies
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Hematological Malignancies
Keywords
Leukemia, Hematologic neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ENMD-2076
Intervention Description
capsule, dose escalation, taken orally, daily in 28 day cycles
Primary Outcome Measure Information:
Title
Define the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of oral daily ENMD 2076 by evaluation of adverse events
Time Frame
Day 1 through first cycle of therapy
Secondary Outcome Measure Information:
Title
Safety and toxicity of repeated oral dosing of ENMD 2076
Time Frame
Throughout study participation
Title
Describe any preliminary evidence of anti-cancer effects of ENMD-2076 in patients with hematological malignancies
Time Frame
monthly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have relapsed/refractory hematological malignancy for which no standard therapies are anticipated to result in a durable remission. Patients with poor-risk myelodysplasia (MDS) [i.e., IPSS ≥ 1.5] or chronic myelomonocytic leukemia (CMML) are also candidates for this protocol. Relapsed/refractory leukemias include acute non lymphocytic leukemia (AML) by WHO classification, acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), or chronic myelogenous leukemia (CML) in blast crisis. Patients with agnogenic myeloid metaplasia (AMM) are also eligible. Patients with relapsed or refractory lymphoma or myeloma may also participate.
Age ≥18 years.
Adequate performance status
Interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for noncytotoxic agents and adequate recovery from prior toxicities. If the patient had a transplant, at least 6 months must have passed before initiation of treatment on this protocol and stable graft versus host disease (no change in severity) for 4 weeks preceding study entry (if applicable).
Persistent clinically significant chronic toxicities from prior therapy must have resolved to baseline or NCI CTCAE Grade < 1
Adequate laboratory results within 10 days of ENMD-2076 administration (unless the abnormality is considered attributable to leukemia)
Exclusion Criteria:
Pregnant or breast-feeding women.
Clinical evidence of bowel obstruction, active uncontrolled malabsorption syndromes or a history of total gastrectomy.
Impaired cardiac function including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, uncontrolled hypertension, or uncontrolled congestive heart failure. Blood pressure must be < 150/90 at the time of enrollment.
Receiving any other treatment for their disease
QTc prolongation defined as ≥ 470 ms.
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Study of ENMD-2076 in Patients With Relapsed or Refractory Hematological Malignancies
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