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Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY)

Sponsor
Disarm Therapeutics (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03997981
Collaborator
Eli Lilly and Company (Industry)
200
Enrollment
12
Locations
52
Anticipated Duration (Months)
16.7
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY)
    Actual Study Start Date :
    Jun 14, 2019
    Anticipated Primary Completion Date :
    Oct 15, 2023
    Anticipated Study Completion Date :
    Oct 15, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Breast cancer patients with weekly/biweekly paclitaxel regimen
    Breast cancer patients receiving docetaxel regimen
    Lymphoma patients receiving vincristine regimen
    Multiple myeloma patients receiving bortezomib regimen
    Colorectal cancer patients receiving oxaliplatin-based regimens

    Outcome Measures

    Primary Outcome Measures

    1. Percent changes in NF-L levels from Baseline to up to 6 months after the last dose of chemotherapy [Through study completion, 2 years]

      Percent changes in NF-L levels from Baseline to up to 6 months after the last dose of chemotherapy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    All of the following criteria must be met in order to be enrolled in the study:

    • Age ≥18 years

    • Life expectancy ≥6 months

    • Participants with Common Terminology Criteria for Adverse Events (CTCAE) Grade 0 CIPN (exception, patients with multiple myeloma treated with bortezomib, CTCAE Grade <=1)

    • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

    • Breast cancer only:

    • Breast cancer beginning treatment with paclitaxel or docetaxel with curative intent (i.e., not metastatic disease beyond regional lymph nodes)

    • Planned minimum of 6 cycles of chemotherapy

    • Lymphoma only:

    • Incident lymphoma initiating treatment with vincristine

    • Planned minimum of 4 cycles of chemotherapy

    • Oxaliplatin-based regimens, Stage III colorectal cancer: Total of 6 months (planned minimum of 12 cycles). May consider Stage IV with minimal metastatic confirmed with Sponsor prior to enrollment

    • Bortezomib use in untreated multiple myeloma: Total of 4 months (planned minimum of 9 cycles)

    • Written informed consent given

    • Enrollment must be completed prior to receiving the first dose of chemotherapy

    Exclusion Criteria:
    Patients meeting ANY of the following criteria are not eligible for participation:

    • Evidence of central nervous system metastases

    • Evidence of clinically significant peripheral neuropathy (CTCAE >2) as defined by patient report of frequent numbness or tingling in the hands or feet

    • Any uncontrolled serious illness or medical condition that would impact the conduct of the current study

    • Previous exposure to neurotoxic chemotherapy drugs

    • Pre-existing neurodegenerative disease (Parkinson's, Alzheimer's, Huntington's, etc.), neuromuscular disorder (multiple sclerosis, ALS, polio, hereditary neuromuscular disease) or history of stoke or history of traumatic brain injury

    • General anesthesia less than one month prior to the first dose of neurotoxic chemotherapy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Arizona Cancer Center Tucson Arizona United States 85724
    2 Marin Cancer Center Greenbrae California United States 94904
    3 Alpha Oncology Research LLC Orange City Florida United States 32763
    4 University of Maryland Baltimore Maryland United States 21201
    5 Johns Hopkins University School of Medicine Baltimore Maryland United States 21287
    6 University of Michigan Ann Arbor Michigan United States 48109
    7 Washington University Saint Louis Missouri United States 63110
    8 Mayo Clinic Rochester New York United States 55905
    9 OSU- James Comprehensive Cancer Center Columbus Ohio United States 43212
    10 University of Pensylvania Philadelphia Pennsylvania United States 19104
    11 University of Vermont Medical Center Burlington Vermont United States 05401
    12 VCU Medical Center Richmond Virginia United States 23298-0211

    Sponsors and Collaborators

    • Disarm Therapeutics
    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Disarm Therapeutics
    ClinicalTrials.gov Identifier:
    NCT03997981
    Other Study ID Numbers:
    • 18232
    • H7I-MC-S028
    • 10001
    First Posted:
    Jun 25, 2019
    Last Update Posted:
    Mar 15, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Disarm Therapeutics
    CIPN
    Additional relevant MeSH terms:
    Peripheral Nervous System Diseases

    Study Results

    No Results Posted as of Mar 15, 2022