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A First In Man Phase I Study Of EPC2407, A Microtubule Inhibitor Anti-Cancer Drug With Tumor Vascular Endothelial Disrupting Activity: Intravenous Administration Daily For Three Days In Patients With Advanced Solid Tumors And Lymphomas


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Cancer

Thank you

Trial Information

A First In Man Phase I Study Of EPC2407, A Microtubule Inhibitor Anti-Cancer Drug With Tumor Vascular Endothelial Disrupting Activity: Intravenous Administration Daily For Three Days In Patients With Advanced Solid Tumors And Lymphomas


This is a Phase I, open label, multicenter, dose-escalation, safety, pharmacokinetic, and
pharmacodynamic study of EPC2407 administered intravenously over 60 minutes on a QDx3
schedule repeated every 21 days. Patients are enrolled and dosed at the level defined by the
escalation scheme. The primary goal of the study design is to assess toxicity at the fixed
dose levels according to the modified Fibonacci schema.


Inclusion Criteria:



1. Histologically or cytologically confirmed solid tumor or lymphoma,which has
progressed on standard therapies, for which effective therapy is not available or for
patients who are unwilling to undergo such therapies.

2. Males and Females at least 18 years of age

3. Laboratory data as specified below (according to the site's clinical laboratory
ranges for normal):

i. Hematology: ANC >1500 cells/mm3, platelet count >100,000 cells/mm3 and Hemoglobin
> 9 gm/L ii. Hepatic: Direct bilirubin <1.5 X ULN; alanine aminotransferase (ALT) or
aspartate aminotransferase (AST) < 2.5 X ULN. For patients with known liver
metastases or liver neoplasms: alanine aminotransferase (ALT) or aspartate
aminotransferase (AST) < 5.0 X ULN iii. Renal: serum creatinine WNL or creatinine
clearance >60 mL/min

4. 12-lead electrocardiogram (ECG) QT intervals: QTc ≤ 450 msec for men and ≤ 470 msec
for women.

5. Estimated life expectancy of at least 3 months

6. ECOG Performance Status < or = 1

7. Previously treated CNS disease allowed if treatment completed and stable for 4 weeks.

8. For men and women of child-producing potential - willingness to employ appropriate
contraceptive methods (including abstinence) during the study

9. Ability to understand the requirements of the study, provide written informed consent
and authorization of use and disclosure of protected health information, and agree to
abide by the study restrictions and to return for the required assessments

10. Cardiac ejection fraction ≥50% by 2D Echocardiogram or > institutional lower limits
of normal

Exclusion Criteria:

1. Women who are pregnant or nursing

2. Radiotherapy or any chemotherapy within the previous 21 days or five half lives of
prior drug (whichever is shorter). See also exclusion #4 below for patients at risk
for cardiac toxicity. Recovery to Grade 1 or less from chemotherapy-induced toxic
effect, except alopecia, is required.

3. Major surgery within the last 4 weeks or minor surgery within the last 2 weeks

4. Significant risk of cardiac drug toxicity due to any of the following: a) Active New
York Heart Association Class III or IV, b) history of or current congestive heart
failure, c) history of myocardial infarction within the last 6 months or ongoing
unstable angina, or anthracycline exposure per exclusion #5.

5. Anthracycline exposure exceeding a cumulative dose of 360 mg/m²

6. Known and ongoing HIV, Hepatitis B or Hepatitis C infection

7. Concomitant use of strong inhibitors of the liver microsomal enzymes CYP2C8, CYP2C9,
CYP2C19 and CYP3A4.

8. Participation in concurrent study of an investigational agent or device

9. Any other condition including but not limited to major co-morbidities, which in the
opinion of the investigator would render the patient ineligible

10. O2 Saturation by pulse oximetry at rest < 90%

11. Concomitant use of drugs that have significant risk of Torsades de Pointes will also
be prohibited. Please refer to drugs listed under "Drugs with Risk of Torsades de
Pointes"

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Outcome Time Frame:

Duration of drug exposure

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

EPC2006-04

NCT ID:

NCT00423410

Start Date:

December 2006

Completion Date:

September 2009

Related Keywords:

  • Advanced Cancer
  • Cancer
  • Tumor
  • Lymphoma
  • Neoplasms

Name

Location

Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Scottsdale HealthcareScottsdale, Arizona  85251
Tower Oncology ResearchBeverly Hills, California  90211