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Protein synthesis inhibitor

Treatment for Peripheral Neuropathy (EPIPHANY Trial)

N/A
Recruiting
Research Sponsored by Disarm Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, 2 years
Awards & highlights

Summary

This is a prospective natural history study of CIPN in approximately 200 participants receiving taxanes (paclitaxel, docetaxel) for breast cancer, bortezomib for multiple myeloma, oxaliplatin-based regimens for colorectal cancer, or vincristine for lymphoma.. Demographic data, medical history, electronic PROs, ClinROs blood biomarkers including NF-L, PGx DNA analyses and Bedside-QST will be assessed at Baseline. The Observation Period will initiate with the first dose of chemotherapy and conclude with the last dose of chemotherapy. During the Observation Period, participants will be evaluated for the development of CIPN using PROs and ClinROs. Blood biomarkers and Bedside-QST will be measured at various timepoints corresponding with treatment regimen schedules throughout the observation period. The Post Chemotherapy Follow-up Period will begin with the first visit after the last dose of chemotherapy and conclude 6 months after the last dose of chemotherapy. During the Post Chemotherapy Follow-up Period, participants will be evaluated for CIPN using PROs and ClinROs. Blood biomarkers and Bedside-QST will also be measured at the beginning and at the end of the Post-Chemotherapy Follow-up Period. PROs will be assessed electronically on a monthly basis.

Eligible Conditions
  • Peripheral Neuropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, 2 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
Percent changes in NF-L levels from Baseline to up to 6 months after the last dose of chemotherapy

Find a Location

Who is running the clinical trial?

Disarm TherapeuticsLead Sponsor
1 Previous Clinical Trials
7 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,640 Previous Clinical Trials
3,221,444 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,358 Previous Clinical Trials
417,890 Total Patients Enrolled
~32 spots leftby Sep 2025