Breast Cancer Clinical Trial

A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors

Summary

This is a first-in-human, open-label, dose escalation study to evaluate the safety and tolerability of pegilodecakin in participants with advanced solid tumors, dosed daily subcutaneously as a monotherapy or in combination with chemotherapy or immunotherapy.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Part A Escalation Cohorts:

o Histologically or cytologically confirmed advanced malignant solid tumor, limited to melanoma, castrate resistant prostate cancer (CRPC), ovarian cancer (OVCA), renal cell carcinoma, colorectal carcinoma (CRC), pancreatic carcinoma or non-small cell lung carcinoma (NSCLC) that is refractory to, intolerant of, for which no standard of therapy is available or where the participant refuses existing therapies

Part A Expansion Cohorts, Part B and C Escalation and Expansion Cohorts:

Tumors with all histological diagnosis or tissue origin may be enrolled

Participants must have failed prior standard curative chemotherapy for their disease, refuse existing therapies OR the proposed chemotherapy regimen to which pegilodecakin is added represents an acceptable standard treatment for their disease.

Measurable or evaluable disease according to irRC or bone metastatic disease evaluable by Prostate Cancer Working Group 2 criteria (PCWG2) for castration-resistant prostate cancer (CRPC)
At least 18 years of age
Performance Status of 0 or 1
Adequate organ function

Exclusion Criteria:

Hematologic malignancies
Pregnant or lactating
Present or history of neurological disorders such as Multiple Sclerosis and Guillain Barre or inflammatory central nervous system/peripheral nervous system (CNS/PNS) disorders
Myocardial infarction within the last 6 months
Unstable angina, or unstable cardiac arrhythmia requiring medication
Surgery within the last 28 days
Systemic fungal, bacterial, viral, or other infection
History of bleeding diathesis within the last 6 months
Positive for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

350

Study ID:

NCT02009449

Recruitment Status:

Active, not recruiting

Sponsor:

Eli Lilly and Company

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There are 9 Locations for this study

See Locations Near You

UCLA Medical Hematology & Oncology
Los Angeles California, 90024, United States
UCSF
San Francisco California, , United States
Sarah Cannon Research Institute at HealthONE
Denver Colorado, 80218, United States
Florida Cancer Specialists & Research Institute
Sarasota Florida, 34232, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Stephenson Cancer Center at Oklahoma University TSET Phase 1 Program
Oklahoma City Oklahoma, 73104, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
The University of Texas M.D. Anderson Cancer Center
Houston Texas, 77030, United States
South Texas Accelerated Research Therapeutics
San Antonio Texas, 78229, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

350

Study ID:

NCT02009449

Recruitment Status:

Active, not recruiting

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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