A Pilot Study of EZN-2968, an Antisense Oligonucleotide Inhibitor of HIF-1alpha, in Adults With A… (NCT01120288) | Clinical Trial Compass
CompletedPhase 1
A Pilot Study of EZN-2968, an Antisense Oligonucleotide Inhibitor of HIF-1alpha, in Adults With Advanced Solid Tumors With Liver Metastases
United States10 participantsStarted 2010-04-29
Plain-language summary
Background:
\- A protein called HIF is believed to be involved both in forming cancers and helping them to grow after they are formed. EZN-2968 is a new type of cancer drug that goes into the cancer cell and switches off the production of the HIF protein. Researchers are interested in testing EZN-2968 in people who have liver cancer because studies have shown that this drug travels to the liver and stays there when the drug is given through a vein.
Objectives:
\- To determine the safety and effectiveness of EZN-2968 on liver cancer.
Eligibility:
\- Individuals 18 years of age and older who have been diagnosed with liver cancer that has not responded to standard treatments.
Design:
* Participants will have an initial screening visit with a physical examination, blood and urine tests, and imaging studies to assess tumor size. Tumor biopsies may also be taken for research purposes.
* Participants will have an undefined number of 6-week treatment cycles of EZN-2968, given once a week for 3 weeks followed by 3 weeks without the drug.
* During each cycle, participants will have additional blood tests and imaging scans to assess tumor response to treatment.
* Cycles of treatment with EZN-2968 may continue until the treatment is not effective, illness requires participants to stop taking the study drug, or the participant chooses to withdraw from the study.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* Eligibility Criteria
Inclusion Criteria
* Patients must have histologically or cytologically confirmed diagnosis of solid tumor. The diagnosis should be confirmed by the Laboratory of Pathology, NIH.
* Patients must have disease that is not amenable to potentially curative resection.
* Disease must be amenable to biopsy, and patients must be willing to undergo tumor biopsies.
* Patients must have failed at least one line of prior therapy for metastatic disease or have a disease for which no standard curative therapy exists. Prior anti-angiogenic therapy is allowed.
* Age (Bullet)18 years. Because no dosing or adverse event data are currently available on the use of EZN-2968 in patients \<18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable.
* Life expectancy of greater than 3 months.
* ECOG performance status 0-2 (Karnofsky (Bullet)60%).
* Patients must have normal organ and marrow function as defined below:
absolute neutrophil count (Bullet)1,500/mcL
platelets (Bullet)100,000/mcL
total bilirubin 1.5 X ULN
AST/ALT 2.5 X institutional ULN
creatinine less than or equal to 1.5 x upper limit of normal
OR
creatinine clearance (measured) greater than or equal to 60 mL/minute for patients with creatinine levels \>1.5 times upper limit of normal
INR 1.4
PTT 40 seconds unless due to lupus anticoagulant
* Urine protein should be screened by urine analysis for urine protein:creatinine (UPC) ratio. For UPC ra…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determine the modulation of HIF-1 alpha mRNA in tumor biopsies pre- and post- administration of EZN-2968.