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Fingolimod Hydrochloride for Breast Cancer

Phase 1
Waitlist Available
Led By Charles L Loprinzi
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Life expectancy >= 6 months.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Awards & highlights

Study Summary

This trial is testing whether fingolimod can prevent nerve pain caused by chemotherapy in breast cancer patients. Fingolimod suppresses immune reactions in the brain, and this study will see if it can reduce neuropathy caused by paclitaxel.

Eligible Conditions
  • Breast Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are expected to live for at least 6 more months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Serially measured total sensory neuropathy scores
Secondary outcome measures
Incidence of adverse events (AEs)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Prevention (fingolimod hydrochloride)Experimental Treatment3 Interventions
Patients receive fingolimod hydrochloride PO QD starting the day before chemotherapy, the day of chemotherapy, and 1 day after chemotherapy for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fingolimod Hydrochloride
2019
Completed Phase 1
~10
Fingolimod
2012
Completed Phase 4
~11330

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,176 Previous Clinical Trials
3,758,049 Total Patients Enrolled
83 Trials studying Breast Cancer
14,036 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,644 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,333 Patients Enrolled for Breast Cancer
Charles L LoprinziPrincipal InvestigatorMayo Clinic
3 Previous Clinical Trials
61 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any additional experiments that have been conducted using Fingolimod Hydrochloride?

"At present, 9 clinical trials are assessing Fingolimod Hydrochloride's efficacy. Out of these, 3 have reached Phase 3. Most studies concerning the drug are situated in Göttingen and Campania; however, 334 different medical sites across the world are trialing it."

Answered by AI

Has this type of clinical experiment ever been conducted before?

"Since 2013, Novartis Pharmaceuticals has been invested in researching Fingolimod Hydrochloride; the initial trial involving 220 patients was concluded and Phase 3 approval granted. Currently, 9 trials of this drug are taking place across 135 cities worldwide, spanning 40 nations."

Answered by AI

What is the overall count of participants in this experiment?

"At the present time, this medical experiment is not actively seeking participants. Although first posted on May 24th 2019 and last updated July 6th 2022, other clinical trials are available for those with breast cancer: 2287 studies in total, plus 9 investigations related to Fingolimod Hydrochloride."

Answered by AI

Is enrollment currently open for this trial?

"Unfortunately, this clinical trial is not currently enrolling. Originally posted on May 24th 2019 and last updated July 6th 2022, it is no longer seeking out candidates. Those searching for other options have 2287 trials actively recruiting patients with breast cancer, as well as 9 studies involving Fingolimod Hydrochloride that are still taking in participants."

Answered by AI

What therapeutic objectives is Fingolimod Hydrochloride commonly employed to achieve?

"Fingolimod Hydrochloride may be beneficial for treating carcinoma in situ, active secondary progressive multiple sclerosis (SPMS), and other forms of Multiple Sclerosis."

Answered by AI

Has Fingolimod Hydrochloride been endorsed by the FDA?

"With limited efficacy and safety data, Fingolimod Hydrochloride scores a 1 on the assessment scale."

Answered by AI
~0 spots leftby Mar 2025