A Dose-Escalation Study of ENMD-2076 Administered Orally to Patients With Advanced Cancer

Recruitment & Eligibility

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.

Study & Design

Arm && Interventions

Group	Intervention	Description
3	ENMD-2076	Recurrent or resistant epithelial ovarian cancer
4	ENMD-2076	Colorectal cancer patients who have progressed and/or failed on irinotecan- and oxaliplatin-based regimens
1	ENMD-2076	Dose-escalation
2	ENMD-2076	Advanced cancer, excluding patients with colorectal or ovarian cancers

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of ENMD-2076	Throughout study treatment

Secondary Outcome Measures

Name	Time	Method
Plasma PK	Throughout study treatment
Evidence of benefit (tumor response, clinical benefit, or tumor marker improvement, if appropriate)	Throughout study treatment

Recruitment & Eligibility