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Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY) (EPIPHANY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03997981
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : March 15, 2022
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company ( Disarm Therapeutics )

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
Chemotherapy-induced Peripheral Neuropathy

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

Resource links provided by the National Library of Medicine


Group/Cohort
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



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


Biospecimen Retention:   Samples With DNA
Serum samples collected for measuring biomarkers


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will enroll approximately 200 participants from a total of approximately 10 sites in the United States. Each participant will participate for a duration of up to 1 year after the first dose of chemotherapy.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997981


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Locations
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United States, Arizona
University of Arizona Cancer Center Not yet recruiting
Tucson, Arizona, United States, 85724
Principal Investigator: Pavani Chalasani, MD, MPH         
United States, California
Marin Cancer Center Not yet recruiting
Greenbrae, California, United States, 94904
Contact    415-925-5000      
Principal Investigator: Kristin Anderson, MD         
United States, Florida
Alpha Oncology Research LLC Recruiting
Orange City, Florida, United States, 32763
Contact    407-353-1915      
Principal Investigator: Santosh Nair, MD         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Principal Investigator: Susan Dorsey, Ph.D, RN, FAAN         
Johns Hopkins University School of Medicine Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact    410-955-8893      
Principal Investigator: N Wagner- Johnston         
United States, Michigan
University of Michigan Completed
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Principal Investigator: Simon Haroutounian, Ph.D, MSc         
United States, New York
Mayo Clinic Not yet recruiting
Rochester, New York, United States, 55905
Principal Investigator: Nathan Staff, MD, Ph.D         
United States, Ohio
OSU- James Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43212
Principal Investigator: Maryam Lustberg, MD, MPH         
United States, Pennsylvania
University of Pensylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Chafic Karam         
United States, Vermont
University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05401
Principal Investigator: Noah Kolb, MD         
United States, Virginia
VCU Medical Center Recruiting
Richmond, Virginia, United States, 23298-0211
Principal Investigator: Gordon Smith, MD         
Sponsors and Collaborators
Disarm Therapeutics
Eli Lilly and Company
Investigators
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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
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Responsible Party: Disarm Therapeutics
ClinicalTrials.gov Identifier: NCT03997981    
Other Study ID Numbers: 18232
H7I-MC-S028 ( Other Identifier: Eli Lilly and Company )
10001 ( Other Identifier: Disarm Therapeutics )
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: March 15, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company ( Disarm Therapeutics ):
CIPN
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases