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.

April 11, 2008
April 15, 2008
January 27, 2016
April 2008
December 2010   (Final data collection date for primary outcome measure)
Safety and tolerability of ENMD-2076 [ Time Frame: Throughout study treatment ]
Same as current
Complete list of historical versions of study NCT00658671 on Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
A Dose-Escalation Study of ENMD-2076 Administered Orally to Patients With Advanced Cancer
An Open-Label, Dose-Escalation, Safety, and Pharmacokinetic Study of ENMD-2076 Administered Orally to Patients With Advanced Cancer
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.
Not Provided
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Cancer
Drug: ENMD-2076
Capsules, daily dosing in 28 day cycles
  • Experimental: 1
    Intervention: Drug: ENMD-2076
  • Experimental: 2
    Advanced cancer, excluding patients with colorectal or ovarian cancers
    Intervention: Drug: ENMD-2076
  • Experimental: 3
    Recurrent or resistant epithelial ovarian cancer
    Intervention: Drug: ENMD-2076
  • Experimental: 4
    Colorectal cancer patients who have progressed and/or failed on irinotecan- and oxaliplatin-based regimens
    Intervention: Drug: ENMD-2076
Diamond JR, Bastos BR, Hansen RJ, Gustafson DL, Eckhardt SG, Kwak EL, Pandya SS, Fletcher GC, Pitts TM, Kulikowski GN, Morrow M, Arnott J, Bray MR, Sidor C, Messersmith W, Shapiro GI. Phase I safety, pharmacokinetic, and pharmacodynamic study of ENMD-2076, a novel angiogenic and Aurora kinase inhibitor, in patients with advanced solid tumors. Clin Cancer Res. 2011 Feb 15;17(4):849-60. doi: 10.1158/1078-0432.CCR-10-2144. Epub 2010 Dec 3.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2012
December 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Plan to Share IPD: Undecided
CASI Pharmaceuticals, Inc.
CASI Pharmaceuticals, Inc.
Not Provided
Study Director: William Gannon, MD, MBA CASI Pharmaceuticals, Inc.
CASI Pharmaceuticals, Inc.
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP