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CEND-1 in Combination With Neoadjuvant FOLFIRINOX With or Without Panitumumab (CENDIFOX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05121038
Recruitment Status : Recruiting
First Posted : November 16, 2021
Last Update Posted : November 24, 2021
Sponsor:
Collaborator:
Cend Therapeutics Inc.
Information provided by (Responsible Party):
Anup Kasi, University of Kansas Medical Center

Brief Summary:
This is a phase IB/IIA trial to ensure the safety of CEND-1 in combination with with Folfirinox with or without Panitumumab for treatment of pancreatic, colon and appendiceal cancers

Condition or disease Intervention/treatment Phase
Colon Cancer Pancreas Cancer Digestive Cancer Drug: CEND-1 Drug: Panitumumab Drug: Folfirinox Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1B/2A Trial Of CEND-1 In Combination With Neoadjuvant FOLFIRINOX Based Therapies In Pancreatic, Colon And Appendiceal Cancers (CENDIFOX)
Actual Study Start Date : October 20, 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Panitumumab

Arm Intervention/treatment
Experimental: Cohort 1 Pancreatic Cancer
Biopsy for tissue immune profile if archived tissue not available. Folfirinox infusion for 3 cycles followed by a repeat biopsy for a second tissue immune profiling. Folfirinox plus CEND1 infusion for 3 cycles. Seventy-two hours after last infusion participant will have surgery.
Drug: CEND-1
The treatment with CEND-1 will be given as an intravenous (IV) infusion (through a needle in a vein) at the clinic once every 14 days (or Day 1 of every 14-day cycle starting in Cycle 4).

Drug: Folfirinox

FOLFIRINOX is a name for a chemotherapy treatment regimen that includes several different drugs that are given in a certain order.

All of these drugs are given as an intravenous (IV) infusion (through a needle in a vein) at the clinic once every 14 days (or Day 1 of every 14-day cycle).

  • Oxaliplatin - dose is 85 mg / m2 the infusion takes about 2 hours. then
  • Leucovorin - dose is 400 mg / m2 - this is given at same time with irinotecan (below) and the infusion takes about 1.5 hours.
  • Irinotecan - dose is 180 mg / m2 - this is given at same time with leucovorin (above), and the infusion takes about 1.5 hours.

then

• Fluorouracil - dose is 2400 mg / m2 - this infusion takes 46 to 48 hours (2 days) with an IV pump done at home.

Other Name: Oxaliplatin,Leucovorin,Irinotecan,Fluorouracil

Experimental: Cohort 2 Peritoneal Mets
Biopsy for tissue immune profile if archived tissue not available. Folfirinox plus Panitumumab (if RAS/BRAF) infusion for 3 cycles followed by a repeat biopsy for a second tissue immune profiling. Folfirinox plus Panitumumab (if RAS/BRAF positive) and CEND1 infusion for 3 cycles. Seventy-two hours after last infusion participant will have surgery.
Drug: CEND-1
The treatment with CEND-1 will be given as an intravenous (IV) infusion (through a needle in a vein) at the clinic once every 14 days (or Day 1 of every 14-day cycle starting in Cycle 4).

Drug: Panitumumab
Up to ten (10) participants with cancer that has spread to certain areas of the body and who have a certain gene in the tumor called "RAS/BRAF wild type" will receive another drug called panitumumab in addition to CEND-1 and FOLFIRINOX.

Drug: Folfirinox

FOLFIRINOX is a name for a chemotherapy treatment regimen that includes several different drugs that are given in a certain order.

All of these drugs are given as an intravenous (IV) infusion (through a needle in a vein) at the clinic once every 14 days (or Day 1 of every 14-day cycle).

  • Oxaliplatin - dose is 85 mg / m2 the infusion takes about 2 hours. then
  • Leucovorin - dose is 400 mg / m2 - this is given at same time with irinotecan (below) and the infusion takes about 1.5 hours.
  • Irinotecan - dose is 180 mg / m2 - this is given at same time with leucovorin (above), and the infusion takes about 1.5 hours.

then

• Fluorouracil - dose is 2400 mg / m2 - this infusion takes 46 to 48 hours (2 days) with an IV pump done at home.

Other Name: Oxaliplatin,Leucovorin,Irinotecan,Fluorouracil

Experimental: Cohort 3 Oligomets Colon Cancer
Biopsy for tissue immune profile if archived tissue not available. Folfirinox plus Panitumumab (if RAS/BRAF) infusion for 3 cycles followed by a repeat biopsy for a second tissue immune profiling. Folfirinox plus Panitumumab (if RAS/BRAF positive) and CEND1 infusion for 3 cycles. Seventy-two hours after last infusion participant will have surgery.
Drug: CEND-1
The treatment with CEND-1 will be given as an intravenous (IV) infusion (through a needle in a vein) at the clinic once every 14 days (or Day 1 of every 14-day cycle starting in Cycle 4).

Drug: Panitumumab
Up to ten (10) participants with cancer that has spread to certain areas of the body and who have a certain gene in the tumor called "RAS/BRAF wild type" will receive another drug called panitumumab in addition to CEND-1 and FOLFIRINOX.

Drug: Folfirinox

FOLFIRINOX is a name for a chemotherapy treatment regimen that includes several different drugs that are given in a certain order.

All of these drugs are given as an intravenous (IV) infusion (through a needle in a vein) at the clinic once every 14 days (or Day 1 of every 14-day cycle).

  • Oxaliplatin - dose is 85 mg / m2 the infusion takes about 2 hours. then
  • Leucovorin - dose is 400 mg / m2 - this is given at same time with irinotecan (below) and the infusion takes about 1.5 hours.
  • Irinotecan - dose is 180 mg / m2 - this is given at same time with leucovorin (above), and the infusion takes about 1.5 hours.

then

• Fluorouracil - dose is 2400 mg / m2 - this infusion takes 46 to 48 hours (2 days) with an IV pump done at home.

Other Name: Oxaliplatin,Leucovorin,Irinotecan,Fluorouracil




Primary Outcome Measures :
  1. Drug Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 24 months ]
    Adverse Events : Counts and proportions of grade 3 -5 Adverse Events


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 48 months ]
    Overall survival (OS) will be reported using median survival time along with a 90% confidence interval

  2. Disease-free survival (DFS) [ Time Frame: 48 months ]
    Disease-free survival (DFS) will be reported using median survival time along with a 90% confidence interval

  3. Overall response rate (ORR) [ Time Frame: 24 months ]
    Overall response rate (ORR) will be reported as a proportion with 90% confidence interval.

  4. RO resection rate (RORR) [ Time Frame: 24 months ]
    RO resection rate (RORR) will be reported as a proportion with 90% confidence interval.

  5. Pathological response rate (PCR) . [ Time Frame: 24 months ]
    Pathological response rate (PCR) will be reported as a proportion with 90% confidence interval.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 1
  • One or more lesions evaluable on MRI, positive emission tomography (PET)/CT, or dedicated CT scan according to RECIST v1.1
  • Patients with histologically confirmed pancreatic ductal adenocarcinomas, colorectal and appendiceal adenocarcinomas
  • For cohort 1: Resectable Pancreatic Cancer: No evidence of distant metastasis and tumor mass showing no extension to superior mesenteric artery (SMA) and hepatic artery. There must be clear fat plane between SMA and celiac axis. Patent superior mesenteric vein (SMV/portal vein (PV) with no distortion of venous architecture. Please refer to 2021 NCCN PDAC Guidelines
  • For cohort 1: Borderline Resectable Pancreatic Cancer: defined as localized cancer with 1 or more of the following features: "a) an interface between the primary tumor and superior mesenteric vein (SMV)-portal vein (PV) measuring 180o or greater of the circumference of the vein wall, and/or b) short-segment occlusion of the SMV-PV with normal vein above and below the level of obstruction that is amenable to resection and venous reconstruction and/or c) short segment interface of any degree between tumor and hepatic artery with normal artery proximal and distal to the interface that is amenable to resection and arterial reconstruction and/or d) an interface between the tumor and SMA or celiac trunk measuring less than 180o of the circumference of the artery wall. Please refer to 2021 National Comprehensive Cancer Network (NCCN) Pancreatic Ductal Adenocarcinoma (PDAC) Guidelines
  • For cohort 2: Peritoneal Metastases due to Colorectal Cancer or Invasive Adenocarcinoma of the Appendix
  • For cohort 3: Oligometastatic colorectal cancer: resectable metastases as determined by multidisciplinary evaluation. Patients with bilobar liver metastases or oligometastatic liver and lung metastases that requires resection of one or more metastases are also allowed
  • Eligible for treatment with FOLFIRINOX with or without panitumumab
  • Life expectancy of at least 3 months
  • Adequate archival tissue from prior biopsy for biomarker evaluation or willingness to undergo biopsy before treatment starts and on treatment
  • Medically fit to undergo complex major abdominal surgery at end of study treatment
  • Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to enrollment
  • Adequate organ function

Exclusion Criteria:

  • Simultaneously enrolled in any therapeutic clinical trial
  • Concurrent use of any other anti-cancer therapy, including chemotherapy, targeted therapy, immunotherapy, or biological agents
  • Prior chemotherapy or any other investigational agents for the treatment of cancer within 2 years prior to enrollment on this study
  • Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
  • Is pregnant or breastfeeding
  • Has a known allergic reaction to any excipient contained in the study drug formulation
  • Active Grade 3 (per the NCI CTCAE, Version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment
  • New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG
  • Known infection with HIV, hepatitis B, or hepatitis C
  • Serious nonmalignant disease (e.g., hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator
  • Participants with known brain metastases. Screening for brain metastases with head imaging is not required
  • History of prior or current synchronous malignancy, except:

    • Malignancy that was treated with curative intent and for which there has been no known active disease for >3 years prior to enrollment
    • Curatively treated non-melanoma skin cancer, cervical cancer in situ, or prostatic intraepithelial neoplasia, without evidence of prostate cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05121038


Contacts
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Contact: KUCC Navigation 9135883671 kucc_navigation@kumc.edu

Locations
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United States, Kansas
The University of Kansas Cancer Center (KUCC) Recruiting
Fairway, Kansas, United States, 66205
Contact: KUCC Navigator    913-588-3671    kucc_navigation@kumc.edu   
The University of Kansas Cancer Center, Westwood Campus Recruiting
Kansas City, Kansas, United States, 66205
Contact: KUCC Navigation    913-588-3671    kucc_navigation@kumc.edu   
United States, Missouri
The University of Kansas Medical Center Recruiting
North Kansas City, Missouri, United States, 64116
Contact: Nurse Navigator    913-945-7552    ctnursenav@kumc.edu   
Sponsors and Collaborators
Anup Kasi
Cend Therapeutics Inc.
Investigators
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Principal Investigator: Anup Kasi, MD University of Kansas Medical Center
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Responsible Party: Anup Kasi, MD, MPH, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT05121038    
Other Study ID Numbers: IIT-2021-CENDIFOX
First Posted: November 16, 2021    Key Record Dates
Last Update Posted: November 24, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Leucovorin
Fluorouracil
Oxaliplatin
Irinotecan
Panitumumab
Folfirinox
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Antineoplastic Agents, Immunological