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siRNA

EphA2 siRNA for Cancer

Phase 1

Recruiting

Led By Shannon Westin

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients should be free of active infection requiring intravenous antibiotics

All patients with histologic proof of advanced solid tumors, who are not candidates for known regimens or protocol treatments of higher efficacy or priority

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing EphA2 siRNA, which may help to treat patients with advanced or recurrent solid tumors. This treatment works by shutting down a gene that causes tumor growth.

Who is the study for?

This trial is for adults with advanced or recurrent solid tumors. Participants must have a performance status indicating they can carry out some activity and care for themselves, be willing to undergo biopsies, and not be on other cancer treatments. They should have measurable disease, acceptable organ function tests, no active infections requiring IV antibiotics, and agree to use birth control. Those with certain cardiovascular diseases, bleeding risks, severe allergies to similar drugs or components used in the study are excluded.Check my eligibility

What is being tested?

The trial is testing EphA2 siRNA encapsulated in DOPC liposomes which might inhibit tumor growth by targeting a gene linked to cancer progression. It's a phase I study aiming to determine the safest dose while observing how well patients tolerate it and its effect on their tumors through biomarker analysis.See study design

What are the potential side effects?

Potential side effects may include reactions at the injection site, flu-like symptoms such as fever or chills, fatigue due to immune system activation by siRNA therapy. Since this is an early-phase trial assessing safety and dosage levels of EphA2-targeting treatment in humans for the first time, detailed side effects will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have an infection that needs IV antibiotics.

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I have an advanced solid tumor and cannot use standard treatments.

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I can take care of myself and perform daily activities.

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My cancer is a solid tumor, not blood-related.

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My side effects from previous cancer treatments are mild or gone.

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I am willing to have biopsies before and after treatment.

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I stopped any cancer treatments 3 weeks before starting the study drug.

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My cancer shows high levels of EphA2 based on a specific test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximal tolerated dose or maximal administered dose

Toxicity profile of ephrin type-A receptor 2-targeting 1,2-dioleoyl-sn-glycero-3-phosphatidylcholine-encapsulated short-interfering ribonucleic acid

Secondary outcome measures

Changes in endothelial and tumor cell apoptosis conducted by terminal deoxynucleotidyl transferase dUTP nick end labeling assay

Changes in ephrin type-A receptor 2 expression

Duration of response

+3 more

Side effects data

From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358

65%

Infusion related reaction

59%

Neutrophil count decreased

41%

Upper respiratory infection

29%

Aspartate aminotransferase increased

29%

Platelet count decreased

24%

Alanine aminotransferase increased

18%

Sinusitis

18%

Urinary tract infection

12%

Tooth infection

Bronchial infection

Acute Coronary Syndrome

Febrile neutropenia

Sepsis

Infections and infestations - Other, specify

Nail infection

Rhinitis infective

Tumor lysis syndrome

Infusion Related Reaction

Wound infection

100%

80%

60%

40%

20%

Study treatment Arm

Phase 2 and MTD (800 mg Entospletinib Daily)

Phase 1, Dose 1 (400 mg Entospletinib Daily)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (EphA2-targeting DOPC-encapsulated siRNA)Experimental Treatment3 Interventions

Patients receive EphA2-targeting DOPC-encapsulated siRNA IV over 120 minutes on days 1 and 4. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,663 Previous Clinical Trials

40,925,829 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,973 Previous Clinical Trials

1,789,245 Total Patients Enrolled

Gateway for Cancer ResearchOTHER

45 Previous Clinical Trials

2,494 Total Patients Enrolled

Media Library

EphA2-targeting DOPC-encapsulated siRNA (siRNA) Clinical Trial Eligibility Overview. Trial Name: NCT01591356 — Phase 1

Cancer Research Study Groups: Treatment (EphA2-targeting DOPC-encapsulated siRNA)

Cancer Clinical Trial 2023: EphA2-targeting DOPC-encapsulated siRNA Highlights & Side Effects. Trial Name: NCT01591356 — Phase 1

EphA2-targeting DOPC-encapsulated siRNA (siRNA) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01591356 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing enrollments for this research experiment?

"According to the information on clinicaltrials.gov, this investigation is currently seeking participants. The trial was initially launched on July 1st 2015 and underwent its most recent revision in August 9th 2022."

Answered by AI

Has the Pharmacological Study been sanctioned by the Federal Drug Administration?

"With limited safety and efficacy data available, our assessment of Pharmacological Study's safety is a 1 out of 3."

Answered by AI

What is the projected participant pool for this clinical experiment?

"Affirmative, according to information on clinicaltrials.gov, this experiment is currently recruiting patients. This research project was first published on July 1st 2015 and has been updated as recently as August 9th 2022. 76 participants are needed from one trial site."

Answered by AI

What aims does this research endeavor hope to accomplish?

"The primary aim of this extensive study, which is slated to last up to 5 years, is to identify the maximum tolerated/administered dose. Secondary objectives involve measuring the duration of response (from when criteria for complete or partial remission are met until disease progresses), tracking changes in ephrin type-A receptor 2 expression through tissue biopsies collected pre and post treatment, as well as recording objective responses from day 1 till relapse/progression."

Answered by AI

Recent research and studies

Molecular Cancer TherapeuticsJournal

Preclinical Mammalian Safety Studies of EPHARNA (DOPC Nanoliposomal Epha2-targeted Sirna)

Wagner, Michael J., Rahul Mitra, Mark J. McArthur, Wallace Baze, Kirstin Barnhart, Sherry Y. Wu, Cristian Rodriguez-Aguayo, et al.. 2017. “Preclinical Mammalian Safety Studies of EPHARNA (DOPC Nanoliposomal Epha2-targeted Sirna)”. Molecular Cancer Therapeutics. American Association for Cancer Research (AACR). doi:10.1158/1535-7163.mct-16-0541.

clinicaltrials.govStudy

EphA2 siRNA in Treating Patients With Advanced or Recurrent Solid Tumors

2015. "EphA2 siRNA in Treating Patients With Advanced or Recurrent Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01591356.

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