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

NCT00658671 | Completed Phase 1

• 1 other identifier: 2076-CL-001
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 2

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.

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of ENMD-2076

  Throughout study treatment

Secondary Outcomes (2)

• Plasma PK

  Throughout study treatment

• Evidence of benefit (tumor response, clinical benefit, or tumor marker improvement, if appropriate)

  Throughout study treatment

Study Arms (4)

1

EXPERIMENTAL

Dose-escalation

Drug: ENMD-2076

2

EXPERIMENTAL

Advanced cancer, excluding patients with colorectal or ovarian cancers

Drug: ENMD-2076

3

EXPERIMENTAL

Recurrent or resistant epithelial ovarian cancer

Drug: ENMD-2076

4

EXPERIMENTAL

Colorectal cancer patients who have progressed and/or failed on irinotecan- and oxaliplatin-based regimens

Drug: ENMD-2076

Interventions

ENMD-2076 DRUG

Capsules, daily dosing in 28 day cycles

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CASI Pharmaceuticals, Inc.: lead

Study Sites (2)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Dana Farber/Harvard Cancer Center

Boston, Massachusetts, United States

Location

Related Publications (1)

• 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.

  PMID: 21131552 RESULT

MeSH Terms

Interventions

ENMD 2076

Study Officials

• William Gannon, MD, MBA

  CASI Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2008
• First Posted: April 15, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2012
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)