Clinical trial · Interventional
Study of EZN-2208 Pediatric Patients With Solid Tumors
A Phase 1/2 Study of EZN-2208 in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Tumors
NCT01295697CI-TRIAL-00056503terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Program suspended and divested
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EZN-2208 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EZN-2208
- description
- Cytotoxic Agent
- interventionNames
- Drug: EZN-2208
Primary outcomes (1)
- measure
- Determine the MTD and recommended phase 2 dose of i.v. EZN-2208 administered q3wk.
- timeFrame
- 2 years
- 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
Secondary outcomes (3)
- measure
- Assess evidence of tumor response activity of EZN-2208
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.