Chemotherapy-induced Peripheral NeuropathyPhase 2NCT07765446
Study of SIR2501 in Solid Tumor Patients Receiving Paclitaxel
A Phase 2 study testing SIR2501 in people with Chemotherapy-induced Peripheral Neuropathy, run by Sironax USA, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-induced Peripheral Neuropathy
- What is being tested?
- SIR2501
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 5 sitesUnited States
- Study dates
- 21 Aug 2026to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years with confirmed solid tumors
- Planned treatment with paclitaxel-based chemotherapy
- ECOG performance status 0-2
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Study site
Baltimore, Maryland, 21287
- Not yet recruiting
Study site
Boston, Massachusetts, 02114
- Recruiting
Study site
East Brunswick, New Jersey, 08816
- Recruiting
Study site
Hollywood, Florida, 33024
- Not yet recruiting
Study site
Winston-Salem, North Carolina, 27104
About this study
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
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).
Read the detailed 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.
- Being tested
- SIR2501
- Keywords
- CIPN, Paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIR2501Drug
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 group | Role | What they receive |
|---|---|---|
| 30 mg | Experimental | Not described Receives: Drug: SIR2501 |
| 45 mg | Experimental | Not described Receives: Drug: SIR2501 |
| 60 mg | Experimental | Not described Receives: Drug: SIR2501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
Incidence of Treatment-Emergent Adverse Events
Measured: From first dose through 1 month after last dose
Secondary outcomes (6)
Secondary Outcome 1 - Pharmacokinetics: Cmax
Maximum Plasma Concentration (Cmax). Cmax of SIR2501 following oral administration
Measured: From first dose through 1 month after last dose
Secondary Outcome 2 - Pharmacokinetics: AUC
Area Under the Plasma Concentration-Time Curve (AUC₀-t). AUC₀-t of SIR2501 following oral administration
Measured: From first dose through 1 month after last dose
Secondary Outcome 3 - Neuropathy: EORTC QLQ CIPN20
Change from baseline in EORTC QLQ CIPN20 sensory subscale. Patient reported neuropathy symptoms using the validated EORTC QLQ CIPN20 questionnaire
Measured: From first dose through 1 month after last dose
Secondary Outcome 4 - Neuropathy: TNS/TNSc
Change from baseline in Total Neuropathy Score/Clinical Version (TNS/TNSc). Clinician rated neuropathy severity using TNS/TNSc
Measured: From first dose through 1 month after last dose
Secondary Outcome 6 - Neuropathy:
NCI CTCAE Grade NCI CTCAE v5.0 grade for CIPN. Clinician graded peripheral neuropathy severity
Measured: From first dose through 1 month after last dose
Secondary Outcome 7 - Pharmacodynamics: NfL
Change from baseline in blood neurofilament light chain (NfL) Description: Plasma NfL concentration measured by validated immunoassay
Measured: From first dose through 1 month after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start21 Aug 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sironax USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765446
- Sponsor's protocol ID
- SIR2501-GLB-201-CIPN
- Status last verified
- Oct 2026
- First submitted
- 31 Jul 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07765446
- Acronym / sponsor ID
- SIR2501-GLB-201-CIPN
- Keywords
- CIPN, Paclitaxel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Sironax USA, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 30 mg | Experimental | Drug: SIR2501 |
| 45 mg | Experimental | Drug: SIR2501 |
| 60 mg | Experimental | Drug: SIR2501 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ≥18 years with confirmed solid tumors
- Planned treatment with paclitaxel-based chemotherapy
- ECOG performance status 0-2
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIR2501Experimental: 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. | Drug | 30 mg, 45 mg, 60 mg |
Primary outcome
Primary Outcome
Time frame: From first dose through 1 month after last dose
Incidence of Treatment-Emergent Adverse Events
6 secondary outcomes
Secondary Outcome 1 - Pharmacokinetics: Cmax
Time frame: From first dose through 1 month after last dose
Secondary Outcome 2 - Pharmacokinetics: AUC
Time frame: From first dose through 1 month after last dose
Secondary Outcome 3 - Neuropathy: EORTC QLQ CIPN20
Time frame: From first dose through 1 month after last dose
Secondary Outcome 4 - Neuropathy: TNS/TNSc
Time frame: From first dose through 1 month after last dose
Secondary Outcome 6 - Neuropathy:
Time frame: From first dose through 1 month after last dose
Secondary Outcome 7 - Pharmacodynamics: NfL
Time frame: From first dose through 1 month after last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SIR2501 in people with Chemotherapy-induced Peripheral Neuropathy, run by Sironax USA, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Monitor (+1-617-580-2520, DL-2501-GLB-201-EligibilityReview@Sironax.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: From first dose through 1 month after last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.