Overview

This trial is active, not recruiting.

Condition advanced cancer
Treatment enmd-2076
Phase phase 1
Target ARK-1
Sponsor EntreMed
Start date April 2008
End date December 2010
Trial size 59 participants
Trial identifier NCT00658671, 2076-CL-001

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Dose-escalation
enmd-2076
Capsules, daily dosing in 28 day cycles
(Experimental)
Advanced cancer, excluding patients with colorectal or ovarian cancers
enmd-2076
Capsules, daily dosing in 28 day cycles
(Experimental)
Recurrent or resistant epithelial ovarian cancer
enmd-2076
Capsules, daily dosing in 28 day cycles
(Experimental)
Colorectal cancer patients who have progressed and/or failed on irinotecan- and oxaliplatin-based regimens
enmd-2076
Capsules, daily dosing in 28 day cycles

Primary Outcomes

Measure
Safety and tolerability of ENMD-2076
time frame: Throughout study treatment

Secondary Outcomes

Measure
Plasma PK
time frame: Throughout study treatment
Evidence of benefit (tumor response, clinical benefit, or tumor marker improvement, if appropriate)
time frame: Throughout study treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title An Open-Label, Dose-Escalation, Safety, and Pharmacokinetic Study of ENMD-2076 Administered Orally to Patients With Advanced Cancer
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by EntreMed.