Contacts

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559 ClinicalTrials.gov@lilly.com

Sponsors

Lead Sponsor

Disarm Therapeutics

Collaborators

Eli Lilly and Company

Age

18 - No limit years

Sex

ALL

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

•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

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What this study is about

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Contacts

Sponsors

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Trial snapshot

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