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

NCT03207724 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-12-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Xilonix plus Onivyde and 5FU

Xilonix by IV

Sponsors & Collaborators

  • Ipsen

    collaborator INDUSTRY

  • Janssen Research & Development, LLC

    collaborator INDUSTRY

  • Andrew Hendifar, MD

    lead OTHER

Principal Investigators

  • Andrew Hendifar, MD · Cedars-Sinai Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-16
Primary Completion
2019-11-21
Completion
2020-10-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03207724 on ClinicalTrials.gov