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

Primary Purpose

Pancreatic Cancer, Cachexia, Weight Loss

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Xilonix plus Onivyde and 5FU

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring advanced pancreatic cancer, locally advanced pancreatic cancer, recurrent diagnosis, new diagnosis, adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Xilonix plus Onivyde and 5FU

Arm Description

interleukin-1-alpha antagonist (Xilonix) in addition to standard chemotherapy of onivyde and 5-fluorouracil/folinic acid (leucovorin)

Outcomes

Primary Outcome Measures

Number of Participants With Dose Limiting Toxicities (DLT) in the First Cycle for the determination of the Maximum Tolerated Dose (MTD)

Assess safety of novel combination

Maximum Tolerated Dose (MTD) of onivyde, 5-fluorouracil/folinic acid in combination with Xilonix

Assess MTD of Onivyde in combination with novel therapy

Secondary Outcome Measures

Weight stability

Mean change from baseline (kg) up to 6 months

Lean Body Mass

Mean change from baseline (kg) up to 6 months

Overall Survival

To measure overall survival up to 12 months from baseline

Progression Free Survival

To measure progression free survival up to 12 months from baseline

Mean change in global quality of life (QOL) score (EORTC Pan26)

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)

Assessment based on patient-reported outcomes up to 6 months from baseline

Full Information

NCT ID

NCT03207724

First Posted

June 30, 2017

Last Updated

December 29, 2020

Sponsor

Andrew Hendifar, MD

Collaborators

Ipsen, Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT03207724

Brief Title

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

Acronym

OnFX

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

October 16, 2017 (Actual)

Primary Completion Date

November 21, 2019 (Actual)

Study Completion Date

October 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Andrew Hendifar, MD

Collaborators

Ipsen, Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer, Cachexia, Weight Loss

Keywords

advanced pancreatic cancer, locally advanced pancreatic cancer, recurrent diagnosis, new diagnosis, adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Xilonix plus Onivyde and 5FU

Arm Type

Experimental

Arm Description

interleukin-1-alpha antagonist (Xilonix) in addition to standard chemotherapy of onivyde and 5-fluorouracil/folinic acid (leucovorin)

Intervention Type

Drug

Intervention Name(s)

Xilonix plus Onivyde and 5FU

Other Intervention Name(s)

interleukin-1-alpha antagonist

Intervention Description

Xilonix by IV

Primary Outcome Measure Information:

Title

Number of Participants With Dose Limiting Toxicities (DLT) in the First Cycle for the determination of the Maximum Tolerated Dose (MTD)

Description

Assess safety of novel combination

Time Frame

28 days (first cycle)

Title

Maximum Tolerated Dose (MTD) of onivyde, 5-fluorouracil/folinic acid in combination with Xilonix

Description

Assess MTD of Onivyde in combination with novel therapy

Time Frame

28 days (first cycle)

Secondary Outcome Measure Information:

Title

Weight stability

Description

Mean change from baseline (kg) up to 6 months

Time Frame

6 months

Title

Lean Body Mass

Description

Mean change from baseline (kg) up to 6 months

Time Frame

6 months

Title

Overall Survival

Description

To measure overall survival up to 12 months from baseline

Time Frame

12 months

Title

Progression Free Survival

Description

To measure progression free survival up to 12 months from baseline

Time Frame

12 months

Title

Mean change in global quality of life (QOL) score (EORTC Pan26)

Description

Assessment based on patient-reported QOL up to 6 months from baseline

Time Frame

6 months

Title

Mean change in global score of patient-reported response to therapy (FAACT questionnaire- Functional Assessment of Anorexia/Cachexia Therapy)

Description

Assessment based on patient-reported outcomes up to 6 months from baseline

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew Hendifar, MD

Organizational Affiliation

Cedars-Sinai Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

36056179

Citation

Gong J, Thomassian S, Kim S, Gresham G, Moshayedi N, Ye JY, Yang JC, Jacobs JP, Lo S, Nissen N, Gaddam S, Tighiouart M, Osipov A, Hendifar A. Phase I trial of Bermekimab with nanoliposomal irinotecan and 5-fluorouracil/folinic acid in advanced pancreatic ductal adenocarcinoma. Sci Rep. 2022 Sep 2;12(1):15013. doi: 10.1038/s41598-022-19401-3. Erratum In: Sci Rep. 2022 Nov 4;12(1):18731.

Results Reference

derived

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

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