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

Pancreatic Cancer Clinical Trial

— OnFX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03207724
• Other study ID #: IIT2016-07-Hendifar-OnFX
• Status: Completed
• Phase: Phase 1
• Start date: October 16, 2017
• Est. completion date: October 27, 2020

Study information

• Verified date: December 2020
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 27, 2020
• Est. primary completion date: November 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cachexia
• Pancreatic Cancer
• Pancreatic Neoplasms
• Weight Loss

Intervention

Drug:
• Xilonix plus Onivyde and 5FU
Xilonix by IV

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Andrew Hendifar, MD	Ipsen, Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Weight stability	Mean change from baseline (kg) up to 6 months	6 months
Secondary	Lean Body Mass	Mean change from baseline (kg) up to 6 months	6 months
Secondary	Overall Survival	To measure overall survival up to 12 months from baseline	12 months
Secondary	Progression Free Survival	To measure progression free survival up to 12 months from baseline	12 months
Secondary	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
Secondary	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