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Hydroxychloroquine and Chlorphenesin Carbamate in Combination With mFOLFIRINOX in Pancreatic Cancer

Sponsor
Changhoon Yoo (Other)
Overall Status
Recruiting
CT.gov ID
NCT05083780
Collaborator
Oncocross Co. Ltd. (Industry), CytoGen, Inc. (Industry)
40
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Chlorphenesin Carbamate, Hydroxychloroquine
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Study of Hydroxychloroquine and Chlorphenesin Carbamate in Combination With mFOLFIRINOX in Inoperable Locally Advanced or Metastatic Pancreatic Cancer
Actual Study Start Date :
Nov 30, 2021
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: mFORFIRINOX, Chlorphenesin Carbamate, Hydroxychloroquine

Drug: Chlorphenesin Carbamate, Hydroxychloroquine
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.

Outcome Measures

Primary Outcome Measures

  1. Number of participants with treatment-related adverse events assessed by CTCAE v5.0 [up to 3 years]

Secondary Outcome Measures

  1. Rate of Progression-Free Survival [6, 12 months]

  2. Rate of Distant Metastasis-Free Survival [6, 12 months]

  3. Overall Survival [up to 3 years]

    Time between study treatment and death

  4. Objective Response Rate [up to 3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. One or more measurable lesions by RECIST v 1.1

  2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 pr 1

  3. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Asan Medical Center Seoul Korea, Republic of 05505

Sponsors and Collaborators

  • Changhoon Yoo
  • Oncocross Co. Ltd.
  • CytoGen, Inc.

Investigators

  • Principal Investigator: Changhoon Yoo, MD, PhD, Asan Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Changhoon Yoo, Associate Professor, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT05083780
Other Study ID Numbers:
  • OC-201/202-001
First Posted:
Oct 19, 2021
Last Update Posted:
Jan 25, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pancreatic Neoplasms
Hydroxychloroquine
Chlorphenesin

Study Results

No Results Posted as of Jan 25, 2022