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Safety and Efficacy of JMKX000189 for Chemotherapy-Induced Peripheral Neuropathy

ConditionCIPN - Chemotherapy-Induced Peripheral Neuropathy
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Jeyou Pharmaceutical Co., Ltd.

About this trial

This Phase Ib clinical trial aims to evaluate the safety, tolerability, and preliminary efficacy of JMKX000189 tablets in participants with chemotherapy-induced peripheral neuropathy (CIPN).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 to 75 years (inclusive), male or female.

Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2.

Life expectancy of ≥ 3 months.

Histologically or cytologically confirmed malignant solid tumors.

Disqualifiers

Presence of any type of peripheral neuropathy other than CIPN (e.g., diabetic, paraneoplastic, or nutritional).

Toxicities from prior anti-tumor therapy (excluding CIPN) > CTCAE Grade 1 within 2 weeks of first dose (excluding alopecia, skin pigmentation, stable hypothyroidism, or chronic events).

Ischemic heart disease or myocardial infarction, unstable angina, coronary artery spasm, congestive heart failure (NYHA Class III-IV), cardiac arrest, stroke, or transient ischemic attack within 6 months;

Other clinically significant cardiac disorders per investigator's judgment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • JMKX000189

    Drug

    JMKX000189 administered orally.

  • Placebo

    Other intervention

    Placebo administered orally.

Treatment groups

18 Participants
are divided into 3 treatment groups
Group A: JMKX000189 Dose 1Experimental treatment 1 intervention
Group B: JMKX000189 Dose 2Experimental treatment 1 intervention
Group C: placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).

Time frame
up to 6 months.

Secondary outcomes

1

The changes in average pain score on brief pain inventory-short form (BPI-SF) from the baseline

Time frame
up to 6 months.
2

The changes in numbness score on FACT/GOG-Ntx from the baseline

Time frame
up to 6 months.
3

Area Under the Curve over the Dosing Interval during Steady State (AUC0-tau)

Time frame
up to 6 months.
4

Maximum Concentration during Steady State (Cmax,ss)

Time frame
up to 6 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Jeyou Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: