Cachexia, Pancreatic Cancer, Weight Loss
Conditions
Keywords
advanced pancreatic cancer, locally advanced pancreatic cancer, recurrent diagnosis, new diagnosis, adenocarcinoma
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.
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.
Interventions
DRUGXilonix plus Onivyde and 5FU
Xilonix by IV
Sponsors
Ipsen
Janssen Research & Development, LLC
Andrew Hendifar, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Weight stability | 6 months | Mean change from baseline (kg) up to 6 months |
| 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 |
| 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 |
| Lean Body Mass | 6 months | Mean change from baseline (kg) up to 6 months |
Countries
United States
Outcome results
None listed