Hydroxychloroquine and Chlorphenesin Carbamate in Combination With mFOLFIRINOX in Pancreatic Cancer

NCT05083780 | Active Not Recruiting Phase 1

• 1 other identifier: OC-201/202-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Pancreatic cancer is the 8th most prevalent cancer in Korea, and its 5-year overall survival rate has shown less than 10% due to its dismal prognosis. To date, the only curative treatment of pancreatic cancer is surgical resection. However, about 60% of patients with pancreatic cancer have been diagnosed as a locally advanced unresectable or metastatic disease at diagnosis owning to its difficulty in the early detection of cancer. The 5-year survival rate has been reported to be less than 25% even with surgical resection. Considering the high rate of metastasis and recurrence, systemic chemotherapy is essential to prolong survival. Therefore, Using AI platforms of RAPTOR (RNA expression-based Anti-symmetrical Pairing Tool for On-demand Response) and ReDRUG (Restoration using the drug for targeting unbalanced gene) developed by Oncocross, Chlorphenesin carbamate, and Hydroxychloroquine were discovered as candidate drugs having anti-metastatic effects. This study aimed to evaluate the efficacy and safety of hydroxychloroquine and chlorphenesin carbamate in combination with mFOLFIRINOX in patients with inoperable locally advanced or metastatic pancreatic cancer.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events assessed by CTCAE v5.0

  up to 3 years

Secondary Outcomes (4)

• Rate of Progression-Free Survival

  6, 12 months

• Rate of Distant Metastasis-Free Survival

  6, 12 months

• Overall Survival

  up to 3 years

• Objective Response Rate

  up to 3 years

Study Arms (1)

mFORFIRINOX, Chlorphenesin Carbamate, Hydroxychloroquine

EXPERIMENTAL

Drug: Chlorphenesin Carbamate, Hydroxychloroquine

Interventions

Chlorphenesin Carbamate, Hydroxychloroquine DRUG

In addition to the mFOLFIRINOX therapy(backbone therapy), chlorphenesin carbamate 250 mg, and hydroxychloroquine 200 mg will be administered orally twice daily for up to 48 weeks.

mFORFIRINOX, Chlorphenesin Carbamate, Hydroxychloroquine

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults of age ≥ 19 and \< 80 years
• A patient who meets any of the following criteria at the time of screening or before, and who is scheduled to receive chemotherapy with modified FOLFIRINOX for the first time after screening
• Locally advanced inoperable pancreatic cancer
• Metastatic pancreatic cancer
• One or more measurable lesions by RECIST v 1.1
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 pr 1
• Estimated life expectancy of at least 12 weeks or more at the discretion of the investigator

You may not qualify if:

• History of major surgery within 4 weeks at the time of screening
• Symptomatic, uncontrolled brain metastasis or meningeal carcinomatosis
• History of malignancy within 5 years at the time of screening
• History of human immunodeficiency virus (HIV) or active hepatitis
• Active infection requiring systemic antibiotic therapy
• Patients who have maculopathy or are receiving treatment for corneal or retinal disease, or under follow-up
• History of acute or subacute intestinal obstruction or paralytic ileus, or a history of chronic diarrhea considered clinically significant at the discretion of the investigator
• Serious neurological, psychiatric condition including drug abuse or alcoholism, which would prevent the subject from participating in the study
• Patients with any condition who are considered unsuitable for participation in the study in the judgment of the investigator

Sponsors & Collaborators

• Changhoon Yoo: lead
• Oncocross Co. Ltd.: collaborator
• CytoGen, Inc.: collaborator

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

chlorphenesin carbamate; Hydroxychloroquine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Changhoon Yoo, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 19, 2021
• Study Start: November 30, 2021
• Primary Completion: December 28, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)