What this study is
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).
What's being tested
- SIR2501
Intervention · DRUG
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.
Study details
- Official title
- A Phase 2, Open-Label Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SIR2501 and Its Potential to Address Paclitaxel-Induced Peripheral Neuropathy
- Sponsor
- Sironax USA, Inc.
- Conditions
- Chemotherapy-induced Peripheral Neuropathy
- Enrolling
- 18 people
- Starts
- 2026-08-21
- Est. completion
- 2027-12-31
- Design
- Open-label, non-randomized, sequential groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Adults ≥18 years with confirmed solid tumors
- Planned treatment with paclitaxel-based chemotherapy
- ECOG performance status 0-2
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (5)
5 openHollywood, Florida, United States
RecruitingBaltimore, Maryland, United States
RecruitingBoston, Massachusetts, United States
Not yet recruitingEast Brunswick, New Jersey, United States
RecruitingWinston-Salem, North Carolina, United States
Not yet recruiting
Study team
Sponsor
Sironax USA, Inc.
Study ID SIR2501-GLB-201-CIPN
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.