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

NCT ID: NCT00658671

Last Updated: 2023-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2012-06-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Dose-escalation

Group Type: EXPERIMENTAL

ENMD-2076

Intervention Type: DRUG

Capsules, daily dosing in 28 day cycles

2

Advanced cancer, excluding patients with colorectal or ovarian cancers

Group Type: EXPERIMENTAL

ENMD-2076

Intervention Type: DRUG

Capsules, daily dosing in 28 day cycles

3

Recurrent or resistant epithelial ovarian cancer

Group Type: EXPERIMENTAL

ENMD-2076

Intervention Type: DRUG

Capsules, daily dosing in 28 day cycles

4

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

Group Type: EXPERIMENTAL

ENMD-2076

Intervention Type: DRUG

Capsules, daily dosing in 28 day cycles

Interventions

ENMD-2076

Capsules, daily dosing in 28 day cycles

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CASI Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Gannon, MD, MBA

Role: STUDY_DIRECTOR

CASI Pharmaceuticals, Inc.

Locations

University of Colorado Hospital

Aurora, Colorado, United States

Dana Farber/Harvard Cancer Center

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21131552 (View on PubMed)

Other Identifiers

2076-CL-001

Identifier Type: -

Identifier Source: org_study_id