Clinical trial · Interventional
Study of ENMD-2076 in Patients With Relapsed or Refractory Hematological Malignancies
A Phase 1 Study of ENMD-2076 in Patients With Relapsed or Refractory Hematological Malignancies
NCT00904787CI-TRIAL-00005320completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To define the maximum tolerated dose of oral daily ENMD 2076 in patients with relapsed or refractory hematological malignancies
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Refractory Hematological Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ENMD-2076 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: ENMD-2076
Primary outcomes (1)
- 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 (2)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.