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Breast CarcinomaPhase 1NCT03941743

Fingolimod in Preventing Paclitaxel-Associated Neuropathy in Patients With Breast Cancer

A Phase 1 study testing Fingolimod, Fingolimod Hydrochloride and Questionnaire Administration in people with Breast Carcinoma, run by Mayo Clinic at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial phase I studies how well fingolimod works in preventing chemotherapy-induced nerve pain (neuropathy) in patients with breast cancer who are taking paclitaxel. Fingolimod acts by suppressing immune reactions in the brain. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Carcinoma
What is being tested?
Fingolimod, Fingolimod Hydrochloride and Questionnaire Administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
3 sitesUnited States
Study dates
12 Dec 2019to 23 Nov 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability to complete questionnaires by themselves or with assistance.
  • Paclitaxel at a dose of 80 mg/m^2 given every week for a scheduled course of 12 weeks for treating breast cancer.
  • Life expectancy >= 6 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1.
  • Negative pregnancy test (serum or urine) done =< 14 days prior to registration, for persons of childbearing potential only.
  • Provide written informed consent.

Who cannot join

  • Previous exposure to paclitaxel (please note that it is acceptable for patients to receive non-neurotoxic chemotherapy, like doxorubicin hydrochloride (Adriamycin) and cyclophosphamide (AC), before or after the weekly paclitaxel and/or to receive concurrent anti-her 2 therapy).
  • Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
  • Pregnant persons
  • Nursing persons
  • Persons of childbearing potential who are unwilling to employ adequate contraception.
  • Previous diagnosis of diabetic or other peripheral neuropathy.
Show all 25Show fewer
  • Current or previous use of fingolimod.
  • History of the following preexisting conditions: ischemic heart disease, cardiac arrest, cerebrovascular disease, uncontrolled hypertension, symptomatic bradycardia, macular edema, recurrent syncope, severe untreated sleep apnea, herpes simplex virus (HSV), varicella zoster virus (VZV), chronic hepatitis, tuberculosis, fungal infections, skin cancer, or diabetes.
  • Myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization or class III/IV heart failure < 6 months prior to registration.
  • History or presence of Mobitz type II second-degree or third-degree atrioventricular (AV) block or sick sinus syndrome, unless patient has a functioning pacemaker.
  • History of a hypersensitivity reaction to fingolimod or any of the excipients including rash, urticarial, and angioedema upon treatment initiation.
  • Baseline corrected QT (QTC) interval >= 450 ms (on electrocardiography [EKG]).
  • Concurrent use of a class Ia or III antiarrhythmic.
  • Drugs with a known risk of torsades de pointes.
  • Concurrent use of beta blockers, calcium channel blockers or digoxin.
  • Use of immunosuppressive, or immune-modulating therapies that may have immunosuppressive effects.
  • Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive.
  • Uncontrolled intercurrent illness including, but not limited to:
  • Ongoing or active infection
  • Unstable angina pectoris
  • Cardiac arrhythmia
  • Or psychiatric illness/social situations that would limit compliance with study requirements.
  • Receiving any other investigational agent.
  • Family history of a genetic/familial neuropathy.
  • Received a vaccine (inactivated) =< 14 days prior to registration.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • The Ohio State University

    Columbus, Ohio, 43212

  • Virginia Commonwealth University/ Massey Cancer Center

    Richmond, Virginia, 23298

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Prevention of Paclitaxel-Associated Neuropathy With Fingolimod: a Pilot Trial

This trial phase I studies how well fingolimod works in preventing chemotherapy-induced nerve pain (neuropathy) in patients with breast cancer who are taking paclitaxel. Fingolimod acts by suppressing immune reactions in the brain. This study is being done to see if fingolimod can reduce neuropathy caused by paclitaxel.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To obtain preliminary data to support whether fingolimod hydrochloride (fingolimod) will prevent chemotherapy-induced peripheral neuropathy (CIPN) in patients receiving weekly adjuvant/neoadjuvant paclitaxel therapy.

SECONDARY OBJECTIVES:

  1. To obtain pilot data regarding the possible relative toxicities related to fingolimod therapy in this study situation.

OUTLINE:

Patients receive fingolimod hydrochloride orally (PO) once daily (QD) starting the day before chemotherapy, the day of chemotherapy, and 1 day after chemotherapy for 12 weeks.

After the completion of study, patients are followed up at 6, 12, and 18 months.

Being tested
Fingolimod, Fingolimod Hydrochloride, Questionnaire Administration
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FingolimodDrug

    Given PO

  • Fingolimod HydrochlorideDrug

    Also called FTY-720, FTY720, Gilenya

    Given PO

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT03941743
Study groupRoleWhat they receive
Prevention (fingolimod hydrochloride)ExperimentalPatients receive fingolimod hydrochloride PO QD starting the day before chemotherapy, the day of chemotherapy, and 1 day after chemotherapy for 12 weeks.
Receives: Drug: Fingolimod; Drug: Fingolimod Hydrochloride; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serially measured total sensory neuropathy scores

    Obtained from the 6 individual Quality of Life Questionnaire (QLQ)-Chemotherapy-Induced Peripheral Neuropathy (CIPN)20 questions that quantify numbness, tingling, and pain in the fingers (or hands) and toes (or feet). The hypothesis will be tested with the two-sided one sample t-test at a significance level of 10%. In the event that the distribution of the patient?s average total sensory neuropathy scores is not approximately normally distributed, then variable transformation or a nonparametric one-sample Wilcoxon signed-rank test will be considered as alternative approaches.

    Measured: Baseline up to 18 months

Secondary outcomes (1)

  1. Incidence of adverse events (AEs)

    Scored using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version (v) 5.0. Will be summarized by reporting the number and percentage of patients. The maximum grade for each type of AE will be recorded for each patient and data listings and frequency tables will be clinically reviewed to determine overall patterns, including AE attribution (possible, probable, and definite) to fingolimod. Additionally, the number and percentage of patients experiencing sensory neuropathy as defined by NCI CTCAE v5.0 will be tabulated by grade (none, mild, moderate, and severe); the proportion of patients experiencing >= grade 2 (moderate) CTCAE sensory neuropathy will estimated with the exact 90% confidence interval.

    Measured: Up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2019
  2. Study start12 Dec 2019
  3. Primary completion5 Jun 2020
  4. Study completion23 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03941743
Sponsor's protocol ID
MC18C1
Other IDs
NCI-2019-02741, MC18C1, P30CA015083
Status last verified
Jul 2023
First submitted
6 May 2019
Last updated
21 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fingolimod, Fingolimod Hydrochloride and Questionnaire Administration in people with Breast Carcinoma, run by Mayo Clinic at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serially measured total sensory neuropathy scores (time frame: Baseline up to 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03941743.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.

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