NCT03554434

Brief Summary

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.

Trial Health

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

First QC Date

May 31, 2018

Last Update Submit

February 27, 2020

Conditions

MelanomaProstate CancerOvarian CancerRenal Cell CarcinomaColorectal CarcinomaPancreatic CarcinomaNon-small Cell Lung CarcinomaSolid TumorsBreast Cancer

Interventions

AM0010BIOLOGICAL

AM0010

Also known as: LY3500518, Pegilodecakin

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

MelanomaProstatic NeoplasmsOvarian NeoplasmsCarcinoma, Renal CellColorectal NeoplasmsPancreatic NeoplasmsCarcinoma, Non-Small-Cell LungBreast Neoplasms

Interventions

AM0010pegilodecakin

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Neoplasms, FemaleEndocrine System DiseasesGonadal DisordersAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialKidney NeoplasmsUrologic NeoplasmsKidney DiseasesUrologic DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPancreatic DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesBreast Diseases

Study Officials

  • Contact Lilly at 1-800-LillyRx (1-800-545-5979)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2018

First Posted

June 13, 2018

Last Updated

March 2, 2020

Record last verified: 2020-02