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

Sponsor

Andrew Hendifar, MD (Other)

Overall Status

Completed

CT.gov ID

NCT03207724

Collaborator

Ipsen (Industry), Janssen Research & Development, LLC (Industry)

Enrollment

Location

Arm

36.4

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer Cachexia Weight Loss	Drug: Xilonix plus Onivyde and 5FU	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 16, 2017

Actual Primary Completion Date :

Nov 21, 2019

Actual Study Completion Date :

Oct 27, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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