AzTrials
AzTrials

Pancreatic CancerPhase 1OnFXNCT03207724

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

A Phase 1 study testing Xilonix plus Onivyde and 5FU in people with Pancreatic Cancer and Cachexia, run by Andrew Hendifar, MD at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer, Cachexia, Weight Loss
What is being tested?
Xilonix plus Onivyde and 5FU
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
16 Oct 2017to 27 Oct 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Xilonix plus Onivyde and 5FU
Keywords
advanced pancreatic cancer, locally advanced pancreatic cancer, recurrent diagnosis, new diagnosis, adenocarcinoma
Medical subject headings
Pancreatic Neoplasms, Cachexia, Weight Loss, Disease, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Xilonix plus Onivyde and 5FUDrug

    Also called interleukin-1-alpha antagonist

    Xilonix by IV

Study groups in NCT03207724
Study groupRoleWhat they receive
Xilonix plus Onivyde and 5FUExperimentalinterleukin-1-alpha antagonist (Xilonix) in addition to standard chemotherapy of onivyde and 5-fluorouracil/folinic acid (leucovorin)
Receives: Drug: Xilonix plus Onivyde and 5FU

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 28 days (first cycle)

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

    Assess MTD of Onivyde in combination with novel therapy

    Measured: 28 days (first cycle)

Secondary outcomes (6)

  1. Weight stability

    Mean change from baseline (kg) up to 6 months

    Measured: 6 months

  2. Lean Body Mass

    Mean change from baseline (kg) up to 6 months

    Measured: 6 months

  3. Overall Survival

    To measure overall survival up to 12 months from baseline

    Measured: 12 months

  4. Progression Free Survival

    To measure progression free survival up to 12 months from baseline

    Measured: 12 months

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

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

    Measured: 6 months

  6. 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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2017
  2. Study start16 Oct 2017
  3. Primary completion21 Nov 2019
  4. Study completion27 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03207724
Sponsor's protocol ID
IIT2016-07-Hendifar-OnFX
Acronym
OnFX
Status last verified
Dec 2020
First submitted
30 Jun 2017
Last updated
30 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 36056179

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Xilonix plus Onivyde and 5FU in people with Pancreatic Cancer and Cachexia, run by Andrew Hendifar, MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03207724, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in