Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY) (EPIPHANY)
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| ClinicalTrials.gov Identifier: NCT03997981 |
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Recruitment Status :
Recruiting
First Posted : June 25, 2019
Last Update Posted : March 15, 2022
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Sponsor:
Disarm Therapeutics
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company ( Disarm Therapeutics )
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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 |
| 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
MedlinePlus related topics:
Peripheral Nerve Disorders
| 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 :
- 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.
| 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
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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
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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
| 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
| 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
| 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 |
| 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 |
| 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 ):
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CIPN |
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases |