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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03207724
Recruitment Status : Active, not recruiting
First Posted : July 5, 2017
Last Update Posted : December 12, 2019
XBiotech, Inc.
Information provided by (Responsible Party):
Andrew Hendifar, MD, Cedars-Sinai Medical Center

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
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 : October 16, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

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 Name: interleukin-1-alpha antagonist

Primary Outcome Measures :
  1. Number of Participants With Dose Limiting Toxicities (DLT) in the First Cycle for the determination of the Maximum Tolerated Dose (MTD) [ Time Frame: 28 days (first cycle) ]
    Assess safety of novel combination

  2. Maximum Tolerated Dose (MTD) of onivyde, 5-fluorouracil/folinic acid in combination with Xilonix [ Time Frame: 28 days (first cycle) ]
    Assess MTD of Onivyde in combination with novel therapy

Secondary Outcome Measures :
  1. Weight stability [ Time Frame: 6 months ]
    Mean change from baseline (kg) up to 6 months

  2. Lean Body Mass [ Time Frame: 6 months ]
    Mean change from baseline (kg) up to 6 months

  3. Overall Survival [ Time Frame: 12 months ]
    To measure overall survival up to 12 months from baseline

  4. Progression Free Survival [ Time Frame: 12 months ]
    To measure progression free survival up to 12 months from baseline

  5. Mean change in global quality of life (QOL) score (EORTC Pan26) [ Time Frame: 6 months ]
    Assessment based on patient-reported QOL up to 6 months from baseline

  6. Mean change in global score of patient-reported response to therapy (FAACT questionnaire- Functional Assessment of Anorexia/Cachexia Therapy) [ Time Frame: 6 months ]
    Assessment based on patient-reported outcomes up to 6 months from baseline

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03207724

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United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Andrew Hendifar, MD
XBiotech, Inc.
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Principal Investigator: Andrew Hendifar, MD Cedars-Sinai Medical Center

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Responsible Party: Andrew Hendifar, MD, Assistant Professor of Medicine, Cedars-Sinai Medical Center Identifier: NCT03207724    
Other Study ID Numbers: IIT2016-07-Hendifar-OnFX
First Posted: July 5, 2017    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrew Hendifar, MD, Cedars-Sinai Medical Center:
advanced pancreatic cancer
locally advanced pancreatic cancer
recurrent diagnosis
new diagnosis
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Wasting Syndrome
Weight Loss
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders
Antibodies, Monoclonal
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors