Safety and Efficacy of JMKX000189 for 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
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
Treatments tested in this trial
- JMKX000189
- Placebo
Treatment groups
18 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov