A Phase 2, Open-Label Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SIR2501 and Its Potential to Address Paclitaxel-Induced Peripheral Neuropathy
Sironax USA, Inc.
Summary
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).
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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
Interventions
- DrugSIR2501
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.
Locations (2)
- Baltimore, Maryland
- East Brunswick, New Jersey