Study of SIR2501 in Solid Tumor Patients Receiving Paclitaxel
A Phase 2, Open-Label Study to Evaluate Safety, Tolerability, and Pharmacokinetics of SIR2501 and Its Potential to Address Paclitaxel-Induced Peripheral Neuropathy
1 other identifier
interventional
18
1 country
2
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2026
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2026
CompletedStudy Start
First participant enrolled
August 3, 2026
CompletedFirst Posted
Study publicly available on registry
August 14, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
August 14, 2026
August 1, 2026
1.4 years
July 31, 2026
August 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Outcome
Incidence of Treatment-Emergent Adverse Events
From first dose through 1 month after last dose
Secondary Outcomes (6)
Secondary Outcome 1 - Pharmacokinetics: Cmax
From first dose through 1 month after last dose
Secondary Outcome 2 - Pharmacokinetics: AUC
From first dose through 1 month after last dose
Secondary Outcome 3 - Neuropathy: EORTC QLQ CIPN20
From first dose through 1 month after last dose
Secondary Outcome 4 - Neuropathy: TNS/TNSc
From first dose through 1 month after last dose
Secondary Outcome 6 - Neuropathy:
From first dose through 1 month after last dose
- +1 more secondary outcomes
Study Arms (3)
30 mg
EXPERIMENTAL45 mg
EXPERIMENTAL60 mg
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Adults ≥18 years with confirmed solid tumors
- Planned treatment with paclitaxel-based chemotherapy
- ECOG performance status 0-2
You may not qualify 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Baltimore, Maryland, 21287, United States
Unknown Facility
East Brunswick, New Jersey, 08816, United States
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2026
First Posted
August 14, 2026
Study Start
August 3, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
August 14, 2026
Record last verified: 2026-08