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A Phase 1/2 Study of EZN-2208 in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Tumors


Phase 1/Phase 2
1 Year
21 Years
Open (Enrolling)
Both
Solid Tumors

Thank you

Trial Information

A Phase 1/2 Study of EZN-2208 in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Tumors


Pharmacokinetic (PK) testing of EZN-2208, will be performed for patients who volunteer. PK
testing measures the amount of a drug in the body at different time points.


Inclusion Criteria:



- Patients with histologic verification of malignancy at original diagnosis or relapse.

- Measurable or evaluable disease

- Karnofsky score more or equal to 50 for patients >16 years of age and Lansky score
more or equal to 50 for patients <16 years of age

- Patients previously treated with irinotecan will be eligible for this study if they
have not had documented progressive disease during treatment with an
irinotecan-containing regimen.

- Adequate hematologic, hepatic, coagulation, renal, and metabolic function

Exclusion Criteria:

- Pregnant or breast feeding patients will not be enrolled in this study

- Patients who are currently receiving other anticancer agents

- Patients who have an uncontrolled infection

- Patients requiring cytochrome P450 3A4 enzyme inducing or inhibiting agents

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the MTD and recommended phase 2 dose of i.v. EZN-2208 administered q3wk.

Outcome Description:

The study will measure incidence, severity and duration of adverse events graded by NCI CTCAE during first cycle of therapy to determine the MTD. A Phase 2 Dose will be recommended by study investigators after considering the frequency and severity of adverse events and the ability to maintain dose schedule

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Rochelle Bagatell, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Developmental Therapeutics Program, The Children's Hospital of Philadelphia, CTRB 4022; 3501 Civic Center Blvd. Philadelphia, PA 19104

Authority:

United States: Food and Drug Administration

Study ID:

EZN-2208-05

NCT ID:

NCT01295697

Start Date:

February 2010

Completion Date:

August 2012

Related Keywords:

  • Solid Tumors
  • Patients with non-CNS or CNS tumors
  • Pediatric patients with Relapsed/Refractory Solid Tumors
  • Neoplasms

Name

Location
Lia Gore, MD Aurora, Colorado  80045
Suzanne Shusterman, MD Boston, Massachusetts  02115
Rochelle Bagatell, MD (Principal Investigator) Philadelphia, Pennsylvania  19104
Jodi Muscal, MD Houston, Texas  77030