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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adults ≥18 years with confirmed solid tumors - Planned treatment with paclitaxel-based chemotherapy - ECOG performance status 0-2

Exclusion Criteria

  • Pre-existing peripheral neuropathy - Conditions or medications that may interfere with neuropathy assessment - Prior exposure to neurotoxic chemotherapy - Use of medications known to mitigate CIPN - Significant medical conditions that may increase study risk

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
30 mg
  • Drug: SIR2501
    Experimental: 30 mg SIR2501 administered at 30 mg dose level. Experimental: 45 mg SIR2501 administered at 45 mg dose level. Experimental: 60 mg SIR2501 administered at 60 mg dose level.
Experimental
45 mg
  • Drug: SIR2501
    Experimental: 30 mg SIR2501 administered at 30 mg dose level. Experimental: 45 mg SIR2501 administered at 45 mg dose level. Experimental: 60 mg SIR2501 administered at 60 mg dose level.
Experimental
60 mg
  • Drug: SIR2501
    Experimental: 30 mg SIR2501 administered at 30 mg dose level. Experimental: 45 mg SIR2501 administered at 45 mg dose level. Experimental: 60 mg SIR2501 administered at 60 mg dose level.

Recruiting Locations

Baltimore, Maryland 21287

More Details

Status
Recruiting
Sponsor
Sironax USA, Inc.

Study Contact

Medical Monitor
+1-617-580-2520
DL-2501-GLB-201-EligibilityReview@Sironax.com

Detailed Description

SIR2501 will be administered to sequential cohorts at increasing dose levels. The study will characterize safety, pharmacokinetics, and preliminary signals related to neuropathy assessment in patients receiving paclitaxel.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.