NCT00520637

Brief Summary

The goal of this clinical research study is to find the highest tolerable dose of EZN-2208 that can be given to patients with advanced cancer or lymphoma. The safety of the study drug and its effect on the disease will also be studied. Enzon will also perform pharmacokinetic (PK) testing of EZN-2208. PK testing measures the amount of a drug in the body at different time points.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

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

May 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2007

Completed
Last Updated

October 9, 2009

Status Verified

October 1, 2009

First QC Date

August 23, 2007

Last Update Submit

October 8, 2009

Conditions

Advanced Solid TumorsLymphoma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Evaluate the safety and tolerability of EZN-2208, assess the pharmacokinetic PK profile of EZN-2208, SN38, and SN38G as well as detect preliminary evidence of tumor response activity of EZN-2208

Interventions

EZN-2208DRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed diagnosis of advanced and/or metastatic solid tumor or lymphoma that is refractory to standard therapy
  • Measurable or evaluable disease
  • Score of 0 to 2 on the ECOG performance scale

You may not qualify if:

  • Concurrent serious medical illness
  • Known, clinically suspected, or history of central nervous system (CNS) tumor involvement
  • Active diarrhea
  • Known history of coagulation disorder
  • Patients requiring cytochrome P450 3A4 (CYP3A4) enzyme inducing medications
  • Requirement for ketoconazole or other strong inhibitor of CYP3A4 enzymes
  • Prior chemotherapy, immunotherapy, investigational agent, or other therapy used to treat the cancer within 4 weeks (6 weeks for prior treatment with mitomycin C or nitrosoureas) prior to the scheduled administration of EZN-2208

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Northwestern University, Feinberg School of Medicine, Division of Hematology/Oncology

Chicago, Illinois, 60611-2927, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Lymphoma

Interventions

EZN-2208

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Razelle Kurzrock, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

  • Mary Frances Mulcahy, MD

    Northwestern University Feinberg School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 23, 2007

First Posted

August 24, 2007

Study Start

May 1, 2007

Last Updated

October 9, 2009

Record last verified: 2009-10

Locations

US(2)