A Phase 2, Open-Label Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SIR2501 and Its Potential to Address Paclitaxel-Induced Peripheral Neuropathy
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adults ≥18 years with confirmed solid tumors
• Planned treatment with paclitaxel-based chemotherapy
• ECOG performance status 0-2
Locations
United States
Maryland
RECRUITING
Baltimore
New Jersey
NOT_YET_RECRUITING
East Brunswick
Contact Information
Primary
Medical Monitor
DL-2501-GLB-201-EligibilityReview@Sironax.com
+1-617-580-2520
Time Frame
Start Date: 2026-08-21
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 18
Treatments
Experimental: 30 mg
Experimental: 45 mg
Experimental: 60 mg
Related Therapeutic Areas
Sponsors
Leads: Sironax USA, Inc.