Solid TumorsPhase 1/2NCT01295697
Study of EZN-2208 Pediatric Patients With Solid Tumors
A Phase 1/2 study testing EZN-2208 in people with Solid Tumors, run by Enzon Pharmaceuticals, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- EZN-2208
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2010to Jan 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Lia Gore, MD
Aurora, Colorado, 80045
Suzanne Shusterman, MD
Boston, Massachusetts, 02115
Jodi Muscal, MD
Houston, Texas, 77030
Rochelle Bagatell, MD (Principal Investigator)
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase 1/2 Study of EZN-2208 in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Tumors
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.
Read the 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.
- Conditions
- Solid Tumors
- Being tested
- EZN-2208
- Keywords
- Patients with non-CNS or CNS tumors, Pediatric patients with Relapsed/Refractory Solid Tumors
- Medical subject headings
- Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EZN-2208Drug
Also called PEG-SN38
Experimental
| Study group | Role | What they receive |
|---|---|---|
| EZN-2208 | Experimental | Cytotoxic Agent Receives: Drug: EZN-2208 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (3)
Assess evidence of tumor response activity of EZN-2208
An evaluation of objective Tumor response by radiographic scans will be performed every two cycles following the criteria of RECIST 1.1.
Measured: 2 years
Evaluate the safety and tolerability of EZN-2208
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.
Measured: 2 years
Assess the PK profile of EZN-2208
The pharmacokinetics of EZN-2208 will be established by measuring the concentration of EZN-2208 and SN-38 over time in patient blood samples.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2011 (estimated)
- Study startFeb 2010
- Primary completionAug 2012
- Study completionJan 2013
Why it stopped: Program suspended and divested
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enzon Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rochelle Bagatell, MD, Study chair, Developmental Therapeutics Program, The Children's Hospital of Philadelphia, CTRB 4022; 3501 Civic Center Blvd. Philadelphia, PA 19104
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295697
- Sponsor's protocol ID
- EZN-2208-05
- Status last verified
- Mar 2012
- First submitted
- 3 Dec 2010
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of EZN-2208 in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT01295697
- Acronym / sponsor ID
- EZN-2208-05
- Conditions
- Solid Tumors
- Keywords
- Patients with non-CNS or CNS tumors, Pediatric patients with Relapsed/Refractory Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Program suspended and divested
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Enzon Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 14 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EZN-2208 | Experimental | Drug: EZN-2208Cytotoxic Agent |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EZN-2208Also: PEG-SN38Experimental | Drug | EZN-2208 |
Primary outcome
Determine the MTD and recommended phase 2 dose of i.v. EZN-2208 administered q3wk.
Time frame: 2 years
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
3 secondary outcomes
Assess evidence of tumor response activity of EZN-2208
Time frame: 2 years
Evaluate the safety and tolerability of EZN-2208
Time frame: 2 years
Assess the PK profile of EZN-2208
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Program suspended and divested). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
Related trials for Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rochelle Bagatell, MD study chair
Developmental Therapeutics Program, The Children's Hospital of Philadelphia, CTRB 4022; 3501 Civic Center Blvd. Philadelphia, PA 19104
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EZN-2208 in people with Solid Tumors, run by Enzon Pharmaceuticals, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Program suspended and divested). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the MTD and recommended phase 2 dose of i.v. EZN-2208 administered q3wk. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2022.