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An Open-Label, Dose-Escalation, Safety, and Pharmacokinetic Study of ENMD-2076 Administered Orally to Patients With Advanced Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced Cancer

Thank you

Trial Information

An Open-Label, Dose-Escalation, Safety, and Pharmacokinetic Study of ENMD-2076 Administered Orally to Patients With Advanced Cancer


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability of ENMD-2076

Outcome Time Frame:

Throughout study treatment

Safety Issue:

Yes

Principal Investigator

William Gannon, MD, MBA

Investigator Role:

Study Director

Investigator Affiliation:

EntreMed

Authority:

United States: Food and Drug Administration

Study ID:

2076-CL-001

NCT ID:

NCT00658671

Start Date:

April 2008

Completion Date:

June 2012

Related Keywords:

  • Advanced Cancer
  • Neoplasms

Name

Location

University of Colorado HospitalDenver, Colorado  80262
Dana Farber/Harvard Cancer CenterBoston, Massachusetts  02115