Clinical trial · Interventional
A Dose-Escalation Study of ENMD-2076 Administered Orally to Patients With Advanced Cancer
An Open-Label, Dose-Escalation, Safety, and Pharmacokinetic Study of ENMD-2076 Administered Orally to Patients With Advanced Cancer
NCT00658671CI-TRIAL-00063697completedPhase 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)
A dose-escalation trial designed to assess the safety and tolerability of treatment with ENMD-2076 administered orally over a range of doses in patients with advanced cancer that is refractory to current treatment or for which no curative therapy exists.
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 |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ENMD-2076 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 1
- description
- Dose-escalation
- interventionNames
- Drug: ENMD-2076
- type
- EXPERIMENTAL
- label
- 2
- description
- Advanced cancer, excluding patients with colorectal or ovarian cancers
- interventionNames
- Drug: ENMD-2076
- type
- EXPERIMENTAL
- label
- 3
- description
- Recurrent or resistant epithelial ovarian cancer
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have histologic proof of advanced cancer that has progressed after treatment and has no standard therapy that is curative or provides clinical benefit. * Meet the modified RECIST Criteria or have disease that can be followed for clinical benefit. * Are greater than or equal to 18 years of age. * AST and ALT ≤ 2.5 times upper limit of normal (ULN) * Total bilirubin ≤ ULN * Creatinine ≤ 1.5 x ULN * Absolute neutrophil count ≥ 1500 cells/mm3 * Platelets ≥ 100,000/mm3 * Hemoglobin ≥ 9.0 g/dL * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Agree to use effective contraceptive methods prior to study entry, during study participation, and for at least 30 days after the last administration of study medication. * Have the ability to understand the requirements of the study, provide written informed consent which includes authorization for release of protected health information, abide by the study restrictions, and agree to return for the required assessments. Exclusion Criteria: * Women who are pregnant or nursing. * Have received radiotherapy or chemotherapy less than two weeks prior to first dose of study medication and have not recovered from all acute toxicities from prior treatments. * Have participated in any clinical trial involving conventional or investigational drugs within 28 days prior to initiation of ENMD-2076 dosing. * Have active, acute, or chronic clinically significant infections. * Have uncontrolled severe hypertension or congestive heart failure. * Have active angina pectoris or recent myocardial infarction (within 6 months). * Have chronic atrial fibrillation or QTc of greater than 470 msec. * Have had major surgery within 21 days of starting therapy. * Have planned surgical treatment of tumor(s) * Have additional uncontrolled serious medical or psychiatric illness. * Have any medical condition that would impair the administration of oral agents including significant bowel resection, inflammatory bowel disease or uncontrolled nausea or vomiting. * Have a 2+ protein by urinalysis or a history of nephrotic syndrome. * Known central nervous system metastasis. * Have history of deep vein thrombosis or pulmonary embolus, unless they are receiving therapeutic anticoagulation with warfarin or low-molecular-weight heparin.
References
Publications (1)
- RESULTDiamond JR, Bastos BR, Hansen RJ, Gustafson DL, Eckhardt SG, Kwak EL, Pandya SS, Fletcher GC, Pitts TM, Kulikowski GN, Morrow M, Arnott J, Bray MR, Sidor C, Messersmith W, Shapiro GI. Phase I safety, pharmacokinetic, and pharmacodynamic study of ENMD-2076, a novel angiogenic and Aurora kinase inhibitor, in patients with advanced solid tumors. Clin Cancer Res. 2011 Feb 15;17(4):849-60. doi: 10.1158/1078-0432.CCR-10-2144. Epub 2010 Dec 3. PMID 21131552