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

NCT ID: NCT03207724

Last Updated: 2020-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-16

Study Completion Date

2020-10-27

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pancreatic Cancer Cachexia Weight Loss

Keywords

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advanced pancreatic cancer locally advanced pancreatic cancer recurrent diagnosis new diagnosis adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Xilonix plus Onivyde and 5FU

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

Group Type EXPERIMENTAL

Xilonix plus Onivyde and 5FU

Intervention Type DRUG

Xilonix by IV

Interventions

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Xilonix plus Onivyde and 5FU

Xilonix by IV

Intervention Type DRUG

Other Intervention Names

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interleukin-1-alpha antagonist

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ipsen

INDUSTRY

Sponsor Role collaborator

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role collaborator

Andrew Hendifar, MD

OTHER

Sponsor Role lead

Responsible Party

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Andrew Hendifar, MD

Assistant Professor of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Andrew Hendifar, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

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Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36056179 (View on PubMed)

Other Identifiers

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IIT2016-07-Hendifar-OnFX

Identifier Type: -

Identifier Source: org_study_id