18 Participants NeededMy employer runs this trial

SIR2501 for Peripheral Neuropathy

Recruiting at 1 trial location
MM
Overseen ByMedical Monitor
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Sironax USA, Inc.
Must be taking: Paclitaxel
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This Phase 2, open-label study will evaluate the safety, tolerability, and pharmacokinetics of SIR2501 in adults with solid tumors who are scheduled to receive paclitaxel-based chemotherapy. The study will also explore whether SIR2501 has the potential to reduce the development of chemotherapy-induced peripheral neuropathy (CIPN).

Are You a Good Fit for This Trial?

This trial is for adults with solid tumors who are about to start paclitaxel-based chemotherapy. Participants should be generally healthy aside from their cancer and able to follow study procedures.

Inclusion Criteria

I am 18 or older and have been diagnosed with a solid tumor.
I am able to care for myself and perform daily activities.
I am scheduled to receive paclitaxel-based chemotherapy.

Exclusion Criteria

Significant medical conditions that may increase study risk
I have nerve damage causing numbness or tingling in my hands or feet.
I have received chemotherapy that can affect the nerves.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

SIR2501 is administered to patients receiving paclitaxel-based chemotherapy to evaluate safety, tolerability, and pharmacokinetics

Duration of paclitaxel treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of treatment-emergent adverse events and neuropathy

1 month

What Are the Treatments Tested in This Trial?

Interventions

  • SIR2501

Trial Overview

The study tests SIR2501, given alongside standard paclitaxel chemotherapy, to see if it is safe and can help prevent or reduce nerve damage (peripheral neuropathy) caused by the chemo.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: 60 mgExperimental Treatment1 Intervention
Group II: 45 mgExperimental Treatment1 Intervention
Group III: 30 mgExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sironax USA, Inc.

Lead Sponsor

Trials
1
Recruited
50+