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CEND-1 + FOLFIRINOX for Digestive Cancer (CENDIFOX Trial)

Phase 1 & 2

Recruiting

Led By Anup Kasi, MD

Research Sponsored by Anup Kasi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 months

Awards & highlights

CENDIFOX Trial Summary

This trial is to test the safety of a new combination treatment for pancreatic, colon, and appendiceal cancers.

Who is the study for?

This trial is for adults with certain types of cancer (pancreatic, colon, or appendiceal) who are in good physical condition and have not had other cancer treatments in the past 2 years. They must be able to understand the study and agree to its terms. Pregnant women and those with serious heart conditions or infections are excluded.Check my eligibility

What is being tested?

The safety of a new drug combination is being tested: CEND-1 with FOLFIRINOX chemotherapy, with some patients also receiving Panitumumab. The goal is to see how well these drugs work together against specific cancers before surgery.See study design

What are the potential side effects?

Possible side effects include typical reactions from chemotherapy like nausea, fatigue, hair loss, and increased risk of infection. CEND-1 may cause additional unknown side effects due to its novelty.

CENDIFOX Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My pancreatic cancer can be surgically removed and hasn't spread far.

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I am fully active or can carry out light work.

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I am eligible for FOLFIRINOX chemotherapy, with or without panitumumab.

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My cancer, originating from the colon or appendix, has spread to the lining of my abdomen.

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My pancreatic cancer is in a stage where surgery might be possible but is complicated.

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I have at least one tumor that can be measured on scans.

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I have been diagnosed with cancer of the pancreas, colon, or appendix.

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I am healthy enough for major abdominal surgery after the study.

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I can provide tissue samples from a previous biopsy or am willing to have one before and during treatment.

CENDIFOX Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Drug Safety: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Secondary outcome measures

Disease-free survival (DFS)

Overall response rate (ORR)

Overall survival (OS)

+2 more

CENDIFOX Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3 Oligomets Colon CancerExperimental Treatment3 Interventions

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.

Group II: Cohort 2 Peritoneal MetsExperimental Treatment3 Interventions

Group III: Cohort 1 Pancreatic CancerExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Folfirinox

2018

Completed Phase 3

~760

Panitumumab

2020

Completed Phase 3

~6490

CEND-1

2018

Completed Phase 1

~30

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Anup KasiLead Sponsor

Cend Therapeutics Inc.UNKNOWN

1 Previous Clinical Trials

50 Total Patients Enrolled

Anup Kasi, MDPrincipal InvestigatorUniversity of Kansas Medical Center

2 Previous Clinical Trials

82 Total Patients Enrolled

Media Library

CEND-1 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05121038 — Phase 1 & 2

Digestive Cancer Research Study Groups: Cohort 1 Pancreatic Cancer, Cohort 2 Peritoneal Mets, Cohort 3 Oligomets Colon Cancer

Digestive Cancer Clinical Trial 2023: CEND-1 Highlights & Side Effects. Trial Name: NCT05121038 — Phase 1 & 2

CEND-1 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05121038 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What pathologies does CEND-1 effectively address?

"CEND-1 has been approved for use in rectal carcinoma treatment and is also useful for managing colorectal carcinoma, ovarian cancer, and sarcoma."

Answered by AI

What additional research has been done in regards to CEND-1?

"At present, 661 clinical trials are in progress researching CEND-1. Of these studies, 201 have reached Phase 3 status. The bulk of tests for this treatment occur at Guangzhou, Guangdong - though there are 27,719 sites running investigations with regard to its efficacy."

Answered by AI

Are there any open slots to join this clinical experiment?

"Affirmative. Clinicaltrials.gov has recorded that this research initiative, which was initially revealed on October 20th 2021, is still accepting participants. 50 volunteers are required to be enrolled from 3 separate sites."

Answered by AI

What is the enrollment population for this clinical trial?

"Affirmative. Information hosted on clinicaltrials.gov demonstrates that this medical study, which was initially posted on October 20th 2021, is currently actively seeking participants. The goal of the research is to recruit 50 patients from 3 separate locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CEND-1 in Combination With Neoadjuvant FOLFIRINOX With or Without Panitumumab

Anup Kasi 2021. "CEND-1 in Combination With Neoadjuvant FOLFIRINOX With or Without Panitumumab". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05121038.

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