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

NCT06722950 | Not Yet Recruiting Phase 2

• 2 other identifiers: NTP-AC591-001Shandong New Time Pharmaceutic
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Colorectal Adenoma

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (10)

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

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

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

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

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

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

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

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

• The change in the EORTCQLQ-C30 score of subjects during CAPEOX chemotherapy from baseline

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

Study Arms (2)

AC591+CAPEOX

EXPERIMENTAL

AC591 granules (3 times a day) + CAPEOX chemotherapy

Drug: CAPEOX; Drug: AC591

Placebo+CAPEOX

PLACEBO COMPARATOR

Placebo (3 times a day) + CAPEOX chemotherapy

Drug: CAPEOX; Drug: Placebo

Interventions

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.

AC591+CAPEOX; Placebo+CAPEOX

Placebo DRUG

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

Placebo+CAPEOX

AC591 DRUG

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

AC591+CAPEOX

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Organ function level before the first medication in the study meets the following requirements:
• Peripheral blood cell count: white blood cell count ≥3×109/L and neutrophil ≥1.5×109/L, platelet count ≥75×109/L, hemoglobin ≥90g/L; Liver function: total bilirubin ≤1.5 times the upper limit of normal reference value; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal reference value; Renal function: serum creatinine ≤1.5 times the upper limit of normal reference value.
• Male or female subjects of fertility are required to take effective medical contraceptive measures until 3 months after the last study administration.

You may not qualify if:

• 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;
• Patients with intestinal obstruction that requires treatment;
• Active severe clinical infection (\> grade 2, National Cancer Institute-Common Adverse Event Evaluation Criteria \[NCI-CTCAE V5.0\]), including active tuberculosis;
• Uncontrolled diabetes, severe lung disease (such as acute lung disease, pulmonary fibrosis affecting lung function, interstitial lung disease, but excluding recovered radiation pneumonia), liver failure;
• Clinically significant cardiovascular disease, New York Heart Association \[NYHA\] grade III-IV congestive heart failure, unstable angina, myocardial infarction, etc. within 6 months before the first dose. Uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg after adequate treatment);
• Patients who need to take coumarin derivative anticoagulants (such as warfarin, phenprocoumon) regularly within 3 weeks before screening or during the study;
• Patients who have used drugs that interfere with the evaluation of neuropathic pain (such as antidepressants, antiepileptic drugs) within 2 weeks before the first dose;
• Renal replacement therapy;
• Previous history of organ transplantation, autologous/allogeneic stem cell transplantation;
• History of other malignant tumors except colorectal cancer in the past 5 years. However, cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, or early papillary thyroid carcinoma are excluded;
• HIV infection, hepatitis B surface antigen positive (and peripheral blood hepatitis B virus deoxynucleotide HBV DNA ≥ 1×104 copies/mL or ≥ 2000IU/mL), hepatitis C virus antibody positive (and peripheral blood hepatitis C virus nucleotide HCV RNA ≥ 1×103 copies/ml or ≥ 200IU/mL) or active syphilis patients;
• Pregnancy (confirmed by menstrual pregnancy test) or lactation;

Sponsors & Collaborators

• Shandong New Time Pharmaceutical Co., LTD: lead

Central Study Contacts

Zhang jian xiang

CONTACT

0539-8330397; jianxiangzhang@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: December 9, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share