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Hydroxychloroquine and Chlorphenesin Carbamate in Combination With mFOLFIRINOX in Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Active
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Chlorphenesin Carbamate, Hydroxychloroquine
Sponsored by
Changhoon Yoo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adults of age ≥ 19 and < 80 years
  2. 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
  3. One or more measurable lesions by RECIST v 1.1
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 pr 1
  5. Estimated life expectancy of at least 12 weeks or more at the discretion of the investigator

Exclusion Criteria:

  1. History of major surgery within 4 weeks at the time of screening
  2. Symptomatic, uncontrolled brain metastasis or meningeal carcinomatosis
  3. History of malignancy within 5 years at the time of screening
  4. History of human immunodeficiency virus (HIV) or active hepatitis
  5. Active infection requiring systemic antibiotic therapy
  6. Patients who have maculopathy or are receiving treatment for corneal or retinal disease, or under follow-up
  7. 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
  8. Serious neurological, psychiatric condition including drug abuse or alcoholism, which would prevent the subject from participating in the study
  9. Patients with any condition who are considered unsuitable for participation in the study in the judgment of the investigator

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

mFORFIRINOX, Chlorphenesin Carbamate, Hydroxychloroquine

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of Progression-Free Survival
Rate of Distant Metastasis-Free Survival
Overall Survival
Time between study treatment and death
Objective Response Rate

Full Information

First Posted
October 6, 2021
Last Updated
July 18, 2023
Sponsor
Changhoon Yoo
Collaborators
Oncocross Co. Ltd., CytoGen, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05083780
Brief Title
Hydroxychloroquine and Chlorphenesin Carbamate in Combination With mFOLFIRINOX in Pancreatic Cancer
Official Title
A Study of Hydroxychloroquine and Chlorphenesin Carbamate in Combination With mFOLFIRINOX in Inoperable Locally Advanced or Metastatic Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Changhoon Yoo
Collaborators
Oncocross Co. Ltd., CytoGen, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mFORFIRINOX, Chlorphenesin Carbamate, Hydroxychloroquine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Chlorphenesin Carbamate, Hydroxychloroquine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events assessed by CTCAE v5.0
Time Frame
up to 3 years
Secondary Outcome Measure Information:
Title
Rate of Progression-Free Survival
Time Frame
6, 12 months
Title
Rate of Distant Metastasis-Free Survival
Time Frame
6, 12 months
Title
Overall Survival
Description
Time between study treatment and death
Time Frame
up to 3 years
Title
Objective Response Rate
Time Frame
up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changhoon Yoo, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Hydroxychloroquine and Chlorphenesin Carbamate in Combination With mFOLFIRINOX in Pancreatic Cancer

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