Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 )

Tracking Information
First Submitted Date June 12, 2019
First Posted Date June 25, 2019
Last Update Posted Date March 15, 2022
Actual Study Start Date June 14, 2019
Estimated Primary Completion Date October 15, 2023   (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, 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Serum samples collected for measuring biomarkers
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.
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
  • Multiple myeloma patients receiving bortezomib regimen
  • Colorectal cancer patients receiving oxaliplatin-based regimens
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 Recruiting
Estimated Enrollment
 (submitted: June 24, 2019)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 15, 2023
Estimated Primary Completion Date October 15, 2023   (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
  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
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
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 2022