Study Of Onivyde And 5-FU In Combination With Xilonix For Pancreatic Cancer With Cachexia

Study Overview

Study of Onivyde and 5-FU in Combination With Xilonix for Pancreatic Cancer With Cachexia

This study is being conducted to examine the safety of the investigational drug, Xilonix(™), in addition to standard doses of Onivyde® (nanoliposomal irinotecan) and 5- fluorouracil (5FU)/folinic acid (leucovorin) for pancreatic cancer patients with cachexia. Cachexia is a syndrome that includes involuntary weight loss and physical deterioration that can contribute to poor outcomes of cancer treatment. In other studies, Xilonix has increased lean body mass in advanced cancer patients. This increase could lead to improved weight maintenance and quality of life.

This study will prospectively evaluate advanced pancreatic adenocarcinoma patients. The intervention will be interleukin-1-alpha antagonist (Xilonix) in addition to standard chemotherapy. The first aim is to assess the safety and identify the maximum tolerated dose of Onivyde with 5-fluorouracil/folinic acid in combination with the study agent, Xilonix. The study will also create a repository of serum, tissue, and fecal specimens to investigate novel biomarkers related to cachexia with pancreatic adenocarcinoma and interleukin-1-alpha blockade. Lastly, the study will assess for a correlation between cachexia, activity, and PROs on domains of quality of life.

Pancreatic Cancer
Cachexia
Weight Loss

DRUG: Xilonix plus Onivyde and 5FU

IIT2016-07-Hendifar-OnFX

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2017-06-30	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-12-29
First Submitted that Met QC Criteria 2017-06-30	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-12-30
First Posted (ACTUAL) 2017-07-05	Results First Posted N/A	Last Verified 2020-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Xilonix plus Onivyde and 5FU interleukin-1-alpha antagonist (Xilonix) in addition to standard chemotherapy of onivyde and 5-fluorouracil/folinic acid (leucovorin)	DRUG: Xilonix plus Onivyde and 5FU Xilonix by IV

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Xilonix plus Onivyde and 5FU

interleukin-1-alpha antagonist (Xilonix) in addition to standard chemotherapy of onivyde and 5-fluorouracil/folinic acid (leucovorin)

DRUG: Xilonix plus Onivyde and 5FU

Xilonix by IV

Primary Outcome Measures	Measure Description	Time Frame
Number of Participants With Dose Limiting Toxicities (DLT) in the First Cycle for the determination of the Maximum Tolerated Dose (MTD)	Assess safety of novel combination	28 days (first cycle)
Maximum Tolerated Dose (MTD) of onivyde, 5-fluorouracil/folinic acid in combination with Xilonix	Assess MTD of Onivyde in combination with novel therapy	28 days (first cycle)

Secondary Outcome Measures	Measure Description	Time Frame
Weight stability	Mean change from baseline (kg) up to 6 months	6 months
Lean Body Mass	Mean change from baseline (kg) up to 6 months	6 months
Overall Survival	To measure overall survival up to 12 months from baseline	12 months
Progression Free Survival	To measure progression free survival up to 12 months from baseline	12 months
Mean change in global quality of life (QOL) score (EORTC Pan26)	Assessment based on patient-reported QOL up to 6 months from baseline	6 months
Mean change in global score of patient-reported response to therapy (FAACT questionnaire- Functional Assessment of Anorexia/Cachexia Therapy)	Assessment based on patient-reported outcomes up to 6 months from baseline	6 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Advanced or locally advanced pancreatic cancer patients (can include new or recurrent diagnosis) referred to SOCCI-CSMC for chemotherapy that has progressed through or intolerant to gemcitabine based chemotherapy
Cachexia defined as greater than 5% unexplained weight loss within any 6 month period prior to screening visit OR as documented by the medical physician based on standard diagnosis of cachexia
Age ≥ 18 years
ECOG performance status 0-2 or Karnofsky PS >60%
Patients must have normal organ and marrow function
Ability to understand and the willingness to sign a written informed consent
Negative pregnancy test for WOCBP
WOCBP and men must agree to use of adequate contraception

Patients who are currently receiving any other investigational agents
Patients who have received more than one chemotherapeutic regimen in metastatic setting
Patients with CNS metastases
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Patients with unresolved grade 3/4 adverse effects of prior therapy at time of enrollment
Subjects with history of hypersensitivity to compounds of similar chemical or biologic composition to Xilonix or Onivyde
Women who are pregnant or breastfeeding
Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
Patients with known Dihydropyrimidine dehydrogenase deficiency (DPD deficiency)
Patients known to be UGT1A1*28 allele homozygous
Patients who have had a live vaccine within 3 months of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Ipsen
Janssen Research & Development, LLC

Investigators

PRINCIPAL_INVESTIGATOR: Andrew Hendifar, MD, Cedars-Sinai Medical Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Gong J, Thomassian S, Kim S, Gresham G, Moshayedi N, Ye JY, Yang JC, Jacobs JP, Lo S, Nissen N, Gaddam S, Tighiouart M, Osipov A, Hendifar A. Phase I trial of Bermekimab with nanoliposomal irinotecan and 5-fluorouracil/folinic acid in advanced pancreatic ductal adenocarcinoma. Sci Rep. 2022 Sep 2;12(1):15013. doi: 10.1038/s41598-022-19401-3.

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Clinical Trial Record