An Expanded Access Program for AM0010 (Pegilodecakin)

February 27, 2020 updated by: Eli Lilly and Company

An Expanded Access Program for AM0010 (Pegilodecakin) Subcutaneous Injection

This is an Expanded Access Program (EAP) available to patients who have advanced cancers, who have failed or progressed on standard of care systemic therapy and do not qualify for ongoing clinical trials.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

  • Patient is NOT eligible for other AM0010 clinical trials currently open in the region
  • Patient is in urgent need of therapy who fail to meet eligibility criteria for other clinical trials related to AM0010 (PEG-IL-10) can be considered for enrollment into this Expanded Access Program.
  • Patient has advanced cancer in indications where preliminary anti-tumor efficacy of AM0010 has been demonstrated or where AM0010 mediated immune activation is likely to benefit the patient.
  • Patient has failed or progressed on standard of care (SOC) systemic therapy
  • Patient is refusing SOC therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Collaborators

ARMO BioSciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 31, 2018

First Submitted That Met QC Criteria

May 31, 2018

First Posted (Actual)

June 13, 2018

Study Record Updates

Last Update Posted (Actual)

March 2, 2020

Last Update Submitted That Met QC Criteria

February 27, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AM0010-99

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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