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

December 29, 2020 updated by: Andrew Hendifar, MD

A Phase I Study of Onivyde and 5-FU in Combination With Xilonix for Advanced 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

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

How is the study designed?

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
Other Names:
  • interleukin-1-alpha antagonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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)
Time Frame: 28 days (first cycle)
Assess safety of novel combination
28 days (first cycle)
Maximum Tolerated Dose (MTD) of onivyde, 5-fluorouracil/folinic acid in combination with Xilonix
Time Frame: 28 days (first cycle)
Assess MTD of Onivyde in combination with novel therapy
28 days (first cycle)

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Andrew Hendifar, MD

Collaborators

Janssen Research & Development, LLC
Ipsen

Publications and helpful links

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

General Publications

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 Major Dates

Study Start (ACTUAL)

October 16, 2017

Primary Completion (ACTUAL)

November 21, 2019

Study Completion (ACTUAL)

October 27, 2020

Study Registration Dates

First Submitted

June 30, 2017

First Submitted That Met QC Criteria

June 30, 2017

First Posted (ACTUAL)

July 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 30, 2020

Last Update Submitted That Met QC Criteria

December 29, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIT2016-07-Hendifar-OnFX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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