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

Sponsor

CASI Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00658671

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

33.5

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Cancer	Drug: ENMD-2076	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

67 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2008

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Dose-escalation	Drug: ENMD-2076 Capsules, daily dosing in 28 day cycles
Experimental: 2 Advanced cancer, excluding patients with colorectal or ovarian cancers	Drug: ENMD-2076 Capsules, daily dosing in 28 day cycles
Experimental: 3 Recurrent or resistant epithelial ovarian cancer	Drug: ENMD-2076 Capsules, daily dosing in 28 day cycles
Experimental: 4 Colorectal cancer patients who have progressed and/or failed on irinotecan- and oxaliplatin-based regimens	Drug: ENMD-2076 Capsules, daily dosing in 28 day cycles

Outcome Measures

Primary Outcome Measures

Safety and tolerability of ENMD-2076 [Throughout study treatment]

Secondary Outcome Measures

Plasma PK [Throughout study treatment]
Evidence of benefit (tumor response, clinical benefit, or tumor marker improvement, if appropriate) [Throughout study treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Hospital	Aurora	Colorado	United States	80045
2	Dana Farber/Harvard Cancer Center	Boston	Massachusetts	United States

Sponsors and Collaborators

CASI Pharmaceuticals, Inc.

Investigators

Study Director: William Gannon, MD, MBA, CASI Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CASI Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT00658671

Other Study ID Numbers:

2076-CL-001

First Posted:

Apr 15, 2008

Last Update Posted:

Jan 27, 2016

Last Verified:

Jan 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Jan 27, 2016