NCT01295697

Brief Summary

The goal of this clinical research study is to find the highest tolerable dose of EZN-2208 that can be given to pediatric patients with Relapsed or Refractory Solid Tumors. The safety of the study drug and its effect on the disease will also be studied.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2010

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 14, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 14, 2022

Status Verified

March 1, 2012

Enrollment Period

2.5 years

First QC Date

December 3, 2010

Last Update Submit

January 29, 2022

Conditions

Solid Tumors

Keywords

Patients with non-CNS or CNS tumorsPediatric patients with Relapsed/Refractory Solid Tumors

Outcome Measures

Primary Outcomes (1)

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

    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

    2 years

Secondary Outcomes (3)

  • Assess evidence of tumor response activity of EZN-2208

    2 years

  • Evaluate the safety and tolerability of EZN-2208

    2 years

  • Assess the PK profile of EZN-2208

    2 years

Study Arms (1)

EZN-2208

EXPERIMENTAL

Cytotoxic Agent

Drug: EZN-2208

Interventions

EZN-2208DRUG

Experimental

Also known as: PEG-SN38
EZN-2208

Eligibility Criteria

Age1 Year - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Lia Gore, MD

Aurora, Colorado, 80045, United States

Location

Suzanne Shusterman, MD

Boston, Massachusetts, 02115, United States

Location

Rochelle Bagatell, MD (Principal Investigator)

Philadelphia, Pennsylvania, 19104, United States

Location

Jodi Muscal, MD

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms

Interventions

EZN-2208

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System Diseases

Study Officials

  • Rochelle Bagatell, MD

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2010

First Posted

February 14, 2011

Study Start

February 1, 2010

Primary Completion

August 1, 2012

Study Completion

January 1, 2013

Last Updated

February 14, 2022

Record last verified: 2012-03

Locations

US(4)