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An Expanded Access Program for AM0010 (Pegilodecakin)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03554434
Expanded Access Status : No longer available
First Posted : June 13, 2018
Last Update Posted : March 2, 2020
Sponsor:
Collaborator:
ARMO BioSciences
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment
Melanoma Prostate Cancer Ovarian Cancer Renal Cell Carcinoma Colorectal Carcinoma Pancreatic Carcinoma Non-small Cell Lung Carcinoma Solid Tumors Breast Cancer Biological: AM0010

Study Design
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Study Type : Expanded Access
Official Title: An Expanded Access Program for AM0010 (Pegilodecakin) Subcutaneous Injection

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Interventions
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Intervention Details:
  • Biological: AM0010
    AM0010
    Other Names:
    • LY3500518
    • Pegilodecakin
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03554434


Sponsors and Collaborators
Eli Lilly and Company
ARMO BioSciences
Investigators
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Study Director: Contact Lilly at 1-800-LillyRx (1-800-545-5979) Eli Lilly and Company
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03554434    
Other Study ID Numbers: AM0010-99
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Colorectal Neoplasms
Carcinoma, Non-Small-Cell Lung
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Endocrine System Diseases
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
 Kidney Diseases
Urologic Diseases
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases