Clinical trial NCT00904787: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Relapsed or Refractory Hematological Malignancies
Keywords: Leukemia
Hematologic neoplasms
Lead sponsor: CASI Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2009-05-20
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To define the maximum tolerated dose of oral daily ENMD 2076 in patients with relapsed or refractory hematological malignancies


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.

Primary outcomes:
measure: Define the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of oral daily ENMD 2076 by evaluation of adverse events
timeFrame: Day 1 through first cycle of therapy
Secondary outcomes:
measure: Safety and toxicity of repeated oral dosing of ENMD 2076
timeFrame: Throughout study participation
measure: Describe any preliminary evidence of anti-cancer effects of ENMD-2076 in patients with hematological malignancies
timeFrame: monthly
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
References: