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

NCT03207724 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: IIT2016-07-Hendifar-OnFX
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pancreatic Cancer; Cachexia; Weight Loss

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Weight stability

  6 months

• Lean Body Mass

  6 months

• Overall Survival

  12 months

• Progression Free Survival

  12 months

• Mean change in global quality of life (QOL) score (EORTC Pan26)

  6 months

Study Arms (1)

Xilonix plus Onivyde and 5FU

EXPERIMENTAL

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

Drug: Xilonix plus Onivyde and 5FU

Interventions

Xilonix plus Onivyde and 5FU DRUG

Xilonix by IV

Also known as: interleukin-1-alpha antagonist

Xilonix plus Onivyde and 5FU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Andrew Hendifar, MD: lead
• Ipsen: collaborator
• Janssen Research & Development, LLC: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (1)

• 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.

  PMID: 36056179 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Cachexia; Weight Loss; Disease; Adenocarcinoma

Interventions

bermekimab; irinotecan sucrosofate; Fluorouracil

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Pathologic Processes; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Andrew Hendifar, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 5, 2017
• Study Start: October 16, 2017
• Primary Completion: November 21, 2019
• Study Completion: October 27, 2020
• Last Updated: December 30, 2020

Record last verified: 2020-12

Locations

US (1)