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Phase II Clinical Study of AC591 in Preventing Oxaliplatin-Induced Peripheral Neuropathy

ConditionColorectal Adenoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShandong New Time Pharmaceutical Co., LTD

About this trial

A randomized, double-blind, placebo-controlled, multicenter, Phase II clinical study of AC591 in preventing Oxaliplatin-Induced Peripheral Neuropathy

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Understand the experimental procedures and contents, and voluntarily sign a written informed consent;

Male or female subjects aged 18 to 75 years (inclusive) when signing the informed consent;

Patients with histologically confirmed colorectal adenocarcinoma. Prepare to receive CAPEOX postoperative adjuvant chemotherapy within 3 weeks to 2 months after surgery, and have never used oxaliplatin;

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 before the first medication in the study;

Disqualifiers

known neurodegenerative disease (e.g., Parkinson's disease, Alzheimer's disease, Huntington's disease) or neuromuscular disease (e.g., multiple sclerosis, amyotrophic lateral sclerosis, poliomyelitis, hereditary neuromuscular disease);

Patients diagnosed with damp-heat syndrome or liver depression-fire syndrome according to TCM during the screening period;

Patients with severe diabetic peripheral neuropathy (such as muscle atrophy as the main stage) and abnormal electromyography;

Patients with known allergic reactions to any component of the study drug;

Trial design

Design model

Parallel

Treatments tested in this trial

  • CAPEOX

    Drug

    CAPEOX: 130mg/m2 of oxaliplatin (D1, central intravenous drip for 2h (time window + 20min)), 1000mg/m2 of capecitabine tablets each time, orally, twice a day (D1-D14, morning and evening); repeat the CAPEOX chemotherapy regimen every 3 weeks.

  • Placebo

    Drug

    Placebo：3 times a day (daily), taken with boiled water.

  • AC591

    Drug

    AC591 : 3 times a day (daily), taken with boiled water.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: AC591+CAPEOXExperimental treatment 2 interventions
Group B: Placebo+CAPEOXPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Proportion of subjects with grade 1-3 oxaliplatin-induced peripheral neuropathy as assessed by the oxaliplatin-specific Levi rating tool

Time frame
At the end of Cycle 4 （each cycle is 21 days）

Secondary outcomes

1

Proportion of subjects with grade 1-3 oxaliplatin-induced peripheral neuropathy as assessed by the oxaliplatin-specific Levi rating tool

Time frame
At the end of Cycle 8（each cycle is 21 days）
2

The time of onset of grade 1-3 oxaliplatin-induced peripheral neuropathy assessed by the Levi rating tool for oxaliplatin

Time frame
At the end of Cycle 4 and 8（each cycle is 21 days）
3

The incidence of NCI-CTCAE V5.0 ≥ grade 2 neurotoxicity in subjects during CAPEOX chemotherapy

Time frame
At the end of Cycle 4 and 8（each cycle is 21 days）
4

The change in the EORTC-QLQ-CIPN20 score of subjects during CAPEOX chemotherapy from baseline

Time frame
at the end of each cycle（each cycle is 21 days）

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Shandong New Time Pharmaceutical Co., LTD

Lead sponsor

Source ClinicalTrials.gov

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