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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00658671
Recruitment Status : Completed
First Posted : April 15, 2008
Last Update Posted : January 27, 2016
Information provided by (Responsible Party):
CASI Pharmaceuticals, Inc.

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

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Study Type : Interventional  (Clinical Trial)
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 : April 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : June 2012

Arm Intervention/treatment
Experimental: 1
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

Primary Outcome Measures :
  1. Safety and tolerability of ENMD-2076 [ Time Frame: Throughout study treatment ]

Secondary Outcome Measures :
  1. Plasma PK [ Time Frame: Throughout study treatment ]
  2. Evidence of benefit (tumor response, clinical benefit, or tumor marker improvement, if appropriate) [ Time Frame: Throughout study treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00658671

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United States, Colorado
University of Colorado Hospital
Aurora, Colorado, United States, 80045
United States, Massachusetts
Dana Farber/Harvard Cancer Center
Boston, Massachusetts, United States
Sponsors and Collaborators
CASI Pharmaceuticals, Inc.
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Study Director: William Gannon, MD, MBA CASI Pharmaceuticals, Inc.

Publications of Results:
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Responsible Party: CASI Pharmaceuticals, Inc. Identifier: NCT00658671     History of Changes
Other Study ID Numbers: 2076-CL-001
First Posted: April 15, 2008    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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