Study of ENMD-2076 in Patients With Relapsed or Refractory Hematological Malignancies

NCT00904787 | Completed Phase 1

• 1 other identifier: 2076-CL-003
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Relapsed or Refractory Hematological Malignancies

Keywords

Leukemia; Hematologic neoplasms

Outcome Measures

Primary Outcomes (1)

• Define the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of oral daily ENMD 2076 by evaluation of adverse events

  Day 1 through first cycle of therapy

Secondary Outcomes (2)

• Safety and toxicity of repeated oral dosing of ENMD 2076

  Throughout study participation

• Describe any preliminary evidence of anti-cancer effects of ENMD-2076 in patients with hematological malignancies

  monthly

Study Arms (1)

1

EXPERIMENTAL

Drug: ENMD-2076

Interventions

ENMD-2076 DRUG

capsule, dose escalation, taken orally, daily in 28 day cycles

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• CASI Pharmaceuticals, Inc.: lead

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Recurrence; Hematologic Neoplasms; Leukemia

Interventions

ENMD 2076

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 19, 2009
• First Posted: May 20, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: May 1, 2011
• Last Updated: August 4, 2011

Record last verified: 2011-08

Locations

CA (1)