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出境医 / 临床实验 / Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY) (EPIPHANY)

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

Study Description
Brief Summary:
This is a prospective natural history study of CIPN in approximately 200 participants receiving taxanes (paclitaxel, docetaxel) for breast cancer or vincristine for lymphoma. Participants will be enrolled over approximately 1-year. Demographic data, medical history, electronic PROs, ClinROs and NF-L 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. NF-L 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. NF-L 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 Design
Layout table for study information
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 : June 30, 2021
Estimated Study Completion Date : June 30, 2021
Arms and Interventions
Group/Cohort
Breast cancer patients with weekly/biweekly paclitaxel regimen
Breast cancer patients receiving docetaxel regimen
Lymphoma patients receiving vincristine regimen
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 [ 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 Without DNA
Serum samples collected for measuring Neurofilament light (NF-L) biomarker

Eligibility Criteria
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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. Approximately 130 breast cancer participants will be enrolled (approximately 65 participants receiving paclitaxel and 65 receiving docetaxel). Approximately 65 participants with lymphoma receiving vincristine will be enrolled
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
  • 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)

  • Lymphoma only:

    • Incident lymphoma initiating treatment with vincristine
    • Planned minimum of 4 cycles of chemotherapy
  • 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 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
  • General anesthesia less than one month prior to enrollment
  • Current use of other adjuvant pharmacologic interventions (eg, duloxetine, gabapentin, pregabalin, venlafaxine) with known or hypothesized efficacy for treatment or prevention of peripheral neuropathy at study entry.
Contacts and Locations

Locations
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United States, Arizona
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, New York
Mayo Clinic
Rochester, New York, United States, 55905
United States, Ohio
OSU- James Comprehensive Cancer Center
Columbus, Ohio, United States, 43212
United States, Pennsylvania
University of Pensylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Vermont
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
United States, Virginia
VCU Medical Center
Richmond, Virginia, United States, 23298-0211
Sponsors and Collaborators
Disarm Therapeutics
Eli Lilly and Company
Investigators
Layout table for investigator information
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
Tracking Information
First Submitted Date June 12, 2019
First Posted Date June 25, 2019
Last Update Posted Date February 2, 2021
Actual Study Start Date June 14, 2019
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 24, 2019) 		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
Original Primary Outcome Measures
 (submitted: June 24, 2019) 		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 yr ]
Percent changes in NF-L levels from Baseline to up to 6 months after the last dose of chemotherapy
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY)
Official Title Chemotherapy Induced Peripheral Neuropathy Natural History Study (EPIPHANY)
Brief Summary This is a prospective natural history study of CIPN in approximately 200 participants receiving taxanes (paclitaxel, docetaxel) for breast cancer or vincristine for lymphoma. Participants will be enrolled over approximately 1-year. Demographic data, medical history, electronic PROs, ClinROs and NF-L 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. NF-L 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. NF-L 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Serum samples collected for measuring Neurofilament light (NF-L) biomarker
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. Approximately 130 breast cancer participants will be enrolled (approximately 65 participants receiving paclitaxel and 65 receiving docetaxel). Approximately 65 participants with lymphoma receiving vincristine will be enrolled
Condition Chemotherapy-induced Peripheral Neuropathy
Intervention Not Provided
Study Groups/Cohorts
  • Breast cancer patients with weekly/biweekly paclitaxel regimen
  • Breast cancer patients receiving docetaxel regimen
  • Lymphoma patients receiving vincristine regimen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Suspended
Estimated Enrollment
 (submitted: June 24, 2019) 		200
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
  • 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)

  • Lymphoma only:

    • Incident lymphoma initiating treatment with vincristine
    • Planned minimum of 4 cycles of chemotherapy
  • 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 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
  • General anesthesia less than one month prior to enrollment
  • Current use of other adjuvant pharmacologic interventions (eg, duloxetine, gabapentin, pregabalin, venlafaxine) with known or hypothesized efficacy for treatment or prevention of peripheral neuropathy at study entry.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03997981
Other Study ID Numbers 18232
H7I-MC-S028 ( Other Identifier: Eli Lilly and Company )
10001 ( Other Identifier: Disarm Therapeutics )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Eli Lilly and Company ( Disarm Therapeutics )
Study Sponsor Disarm Therapeutics
Collaborators 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
PRS Account Eli Lilly and Company
Verification Date January 2021

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