Clinical Trials /

Phase 2 Study - Aurora + Angiogenic Kinase Inhibitor ENMD-2076 in Previously Treated Locally Advanced + Metastatic TNBC

NCT01639248

Description:

The purpose of this study is to determine the activity of ENMD-2076 as defined by the clinical benefit rate when patients with previously treated locally advanced or metastatic triple negative breast cancer are treated with daily oral ENMD-2076.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Phase 2 Study - Aurora + Angiogenic Kinase Inhibitor ENMD-2076 in Previously Treated Locally Advanced + Metastatic TNBC
  • Official Title: A Phase II Study of the Aurora and Angiogenic Kinase Inhibitor ENMD-2076 in Previously Treated Locally Advanced and Metastatic Triple-Negative Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: 2076-CL-005
  • NCT ID: NCT01639248

Conditions

  • Triple Negative Breast Cancer

Interventions

DrugSynonymsArms
ENMD-2076ENMD-2076 Treatment

Purpose

The purpose of this study is to determine the activity of ENMD-2076 as defined by the clinical benefit rate when patients with previously treated locally advanced or metastatic triple negative breast cancer are treated with daily oral ENMD-2076.

Trial Arms

NameTypeDescriptionInterventions
ENMD-2076 TreatmentExperimentalENMD-2076
  • ENMD-2076

Eligibility Criteria

        Inclusion Criteria:

          1. Patients must have histologically or cytologically diagnosed locally advanced or
             metastatic triple-negative breast cancer defined as negative for estrogen receptor,
             progesterone receptor and HER2.

          2. Patients must have measurable disease as defined by revised RECIST criteria (version
             1.1, Appendix C) with one or more lesions that can be accurately measured in one or
             more dimensions within 4 weeks of entry. Areas of previous radiation may not serve as
             measurable disease.

          3. Prior treatment with one to three lines of systemic chemotherapy for locally advanced
             or metastatic disease and two weeks from any previous anticancer therapy including
             biologics and recovered from expected toxicity; at least 4 weeks from major surgery
             and recovered; at least 3 weeks from radiation affecting more than 25% of bone marrow
             and recovered; and 2 weeks from other palliative radiation and recovered. No more than
             450 mg/m2 cumulative dose of doxorubicin is allowed.

          4. Because no dosing or adverse event data are currently available on the use of
             ENMD-2076 in patients <18 years of age, children are excluded from this study but will
             be eligible for future pediatric single-agent trials, if applicable.

          5. ECOG performance status ≤ 1 (Karnofsky ≥ 70%; see Appendix B).

          6. Patients must have normal organ and marrow function

          7. Patients must have a pre-study echocardiogram or multigated acquisition (MUGA) scan
             with an actual left ventricular ejection fraction of greater than or equal to the
             institution lower limit of normal within one month prior to start of study.

          8. If the maximum number of non-biopsy subjects has accrued to the study, willingness to
             undergo 2 tumor biopsies. NOTE: Tumor biopsies may be required, depending on the
             number of subjects who have agreed to undergo correlative studies.

          9. Ability to tolerate oral medications.

         10. Women of child producing potential must 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. A serum pregnancy test within 72 hours prior
             to the initiation of therapy will be required for women of childbearing potential.

         11. 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.

         12. Availability of archival tumor tissue (core biopsy or surgical tumor blocks) for
             analysis. Sites will be asked to submit archival tissue (subjects may start the study
             if tissue is available at an outside hospital, but not yet requested or received).

        Exclusion Criteria:

          1. Women who are pregnant or nursing.

          2. Have active, acute, or chronic clinically significant infections or bleeding.

          3. Have uncontrolled hypertension (systolic blood pressure greater than 150mmHg or
             diastolic blood pressure greater than 100mmHg); or history of congestive heart failure
             (equal to or greater than Grade 2).

          4. Have active angina pectoris, stroke or recent myocardial infarction (within 6 months).

          5. Have chronic atrial fibrillation or QTc interval corrected for heart rate of greater
             than 470 msec.

          6. Have additional uncontrolled serious medical or psychiatric illness.

          7. Require therapeutic doses of any anti-coagulant.

          8. CNS metastases.

          9. Have any medical condition that would impair the administration of oral agents
             including recurrent bowel obstructions, inflammatory bowel disease or uncontrolled
             nausea, vomiting or diarrhea.

         10. Have persistent 2+ protein by urinalysis (patients with 2+ proteinuria that have a
             spot protein:creatinine ratio of less than 0.3 may be enrolled) or a history of
             nephrotic syndrome.

         11. Have an additional malignancy diagnosed within 5 years of study enrollment with the
             exception of basal or squamous cell skin cancer or cervical cancer in situ.

         12. Patients may not be receiving any other investigational agents.

         13. For patients undergoing serial tumor biopsies, known bleeding diathesis or history of
             abnormal bleeding or require anti-coagulation therapy.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Clinical benefit rate
Time Frame:24 weeks
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:CASI Pharmaceuticals, Inc.

Trial Keywords

  • Breast Cancer

Last Updated

June 23, 2017