- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05121038
CEND-1 in Combination With Neoadjuvant FOLFIRINOX With or Without Panitumumab (CENDIFOX)
A Phase 1B/2A Trial Of CEND-1 In Combination With Neoadjuvant FOLFIRINOX Based Therapies In Pancreatic, Colon And Appendiceal Cancers (CENDIFOX)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Kansas
-
Fairway, Kansas, United States, 66205
- Recruiting
- The University of Kansas Cancer Center (KUCC)
-
Kansas City, Kansas, United States, 66205
- Recruiting
- The University of Kansas Cancer Center, Westwood Campus
-
-
Missouri
-
North Kansas City, Missouri, United States, 64116
- Recruiting
- The University of Kansas Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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).
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).
then • Fluorouracil - dose is 2400 mg / m2 - this infusion takes 46 to 48 hours (2 days) with an IV pump done at home.
Other Names:
|
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.
|
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).
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).
then • Fluorouracil - dose is 2400 mg / m2 - this infusion takes 46 to 48 hours (2 days) with an IV pump done at home.
Other Names:
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.
|
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.
|
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).
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).
then • Fluorouracil - dose is 2400 mg / m2 - this infusion takes 46 to 48 hours (2 days) with an IV pump done at home.
Other Names:
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: 48 months
|
Overall survival (OS) will be reported using median survival time along with a 90% confidence interval
|
48 months
|
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
|
48 months
|
Overall response rate (ORR)
Time Frame: 24 months
|
Overall response rate (ORR) will be reported as a proportion with 90% confidence interval.
|
24 months
|
RO resection rate (RORR)
Time Frame: 24 months
|
RO resection rate (RORR) will be reported as a proportion with 90% confidence interval.
|
24 months
|
Pathological response rate (PCR) .
Time Frame: 24 months
|
Pathological response rate (PCR) will be reported as a proportion with 90% confidence interval.
|
24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Anup Kasi, MD, University of Kansas Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Micronutrients
- Vitamins
- Topoisomerase I Inhibitors
- Antidotes
- Vitamin B Complex
- Fluorouracil
- Oxaliplatin
- Leucovorin
- Irinotecan
- Panitumumab
- Folfirinox
Other Study ID Numbers
- IIT-2021-CENDIFOX
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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