Study of SIR2501 in Solid Tumor Patients Receiving Paclitaxel
Part of paid clinical trials in Baltimore, Maryland.
- Sponsor
- Sironax USA, Inc.
- Study ID
- NCT07765446
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Chemotherapy-induced Peripheral Neuropathy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- SIR2501 — DRUGExperimental: 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
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).
Key Dates
- First listed
- Aug 14, 2026
- Start date
- Aug 3, 2026
- Status verified
- Aug 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 18 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- PREVENTION
Arms
- Experimental: 30 mg
- Experimental: 45 mg
- Experimental: 60 mg
Primary Outcome Measure
Primary Outcome [ Time Frame: From first dose through 1 month after last dose ]
Central Contacts
- Medical Monitor+1-617-580-2520
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| - | Baltimore | Maryland | 21287 | - |
| - | East Brunswick | New Jersey | 08816 | - |
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