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

Andrew Hendifar, MD

Status and phase

Completed

Phase 1

Conditions

Weight Loss

Cachexia

Pancreatic Cancer

Treatments

Drug: Xilonix plus Onivyde and 5FU

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03207724

IIT2016-07-Hendifar-OnFX

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No 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