Study of SIR2501 in Solid Tumor Patients Receiving Paclitaxel
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSironax USA, Inc.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Adults ≥18 years with confirmed solid tumors
Planned treatment with paclitaxel-based chemotherapy
ECOG performance status 0-2
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
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.
Treatment groups
18 Participants
are divided into 3 treatment groupsGroup A: 30 mgExperimental treatment 1 intervention
Group B: 45 mgExperimental treatment 1 intervention
Group C: 60 mgExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Outcome
Incidence of Treatment-Emergent Adverse Events
Time frame
From first dose through 1 month after last doseSecondary outcomes
1
Secondary Outcome 1 - Pharmacokinetics: Cmax
Maximum Plasma Concentration (Cmax). Cmax of SIR2501 following oral administration
Time frame
From first dose through 1 month after last dose2
Secondary Outcome 2 - Pharmacokinetics: AUC
Area Under the Plasma Concentration-Time Curve (AUC₀-t). AUC₀-t of SIR2501 following oral administration
Time frame
From first dose through 1 month after last dose3
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
Time frame
From first dose through 1 month after last dose4
Secondary Outcome 4 - Neuropathy: TNS/TNSc
Change from baseline in Total Neuropathy Score/Clinical Version (TNS/TNSc). Clinician rated neuropathy severity using TNS/TNSc
Time frame
From first dose through 1 month after last doseSponsors and contacts
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Source ClinicalTrials.gov