Study of EZN-2208 Pediatric Patients With Solid Tumors
This study is ongoing, but not recruiting participants.
Sponsor:
Enzon Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Enzon Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01295697
First received: December 3, 2010
Last updated: March 7, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Tumors |
Drug: EZN-2208 |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1/2 Study of EZN-2208 in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Tumors |
Resource links provided by NLM:
Further study details as provided by Enzon Pharmaceuticals, Inc.:
Primary Outcome Measures:
- Determine the MTD and recommended phase 2 dose of i.v. EZN-2208 administered q3wk. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
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
Secondary Outcome Measures:
- Assess evidence of tumor response activity of EZN-2208 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]An evaluation of objective Tumor response by radiographic scans will be performed every two cycles following the criteria of RECIST 1.1.
- Evaluate the safety and tolerability of EZN-2208 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]The incidence, severity and duration of adverse events graded by NCI CTCAE during all cycles of therapy will be used to assess safety and tolerability.
- Assess the PK profile of EZN-2208 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]The pharmacokinetics of EZN-2208 will be established by measuring the concentration of EZN-2208 and SN-38 over time in patient blood samples.
| Estimated Enrollment: | 24 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: EZN-2208
Cytotoxic Agent
|
Drug: EZN-2208
Experimental
Other Name: PEG-SN38
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 1 Year to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01295697
Locations
| United States, Colorado | |
| Lia Gore, MD | |
| Aurora, Colorado, United States, 80045 | |
| United States, Massachusetts | |
| Suzanne Shusterman, MD | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Pennsylvania | |
| Rochelle Bagatell, MD (Principal Investigator) | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| Jodi Muscal, MD | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Enzon Pharmaceuticals, Inc.
Investigators
| Study Chair: | Rochelle Bagatell, MD | Developmental Therapeutics Program, The Children's Hospital of Philadelphia, CTRB 4022; 3501 Civic Center Blvd. Philadelphia, PA 19104 |
More Information
No publications provided
| Responsible Party: | Enzon Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01295697 History of Changes |
| Other Study ID Numbers: | EZN-2208-05 |
| Study First Received: | December 3, 2010 |
| Last Updated: | March 7, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Enzon Pharmaceuticals, Inc.:
|
Patients with non-CNS or CNS tumors Pediatric patients with Relapsed/Refractory Solid Tumors |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 19, 2013