A Study of LY3164530 in Participants With Cancer

Completed · Phase 1

Conditions studied: Neoplasms, Neoplasm Metastasis

In brief

The main purpose of this study is to evaluate the safety of a study drug known as LY3164530 in participants with cancer that is advanced and/or has spread to another part(s) of the body.

Key facts

Study ID

NCT02221882

Run by

Eli Lilly and Company

People needed

29

Starts

2014-08-01

Expected to finish

2017-03-07

Last updated by the study team

2019-10-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have advanced or metastatic cancer and be an appropriate candidate for experimental therapy.
• Have adequate organ function.
• Prior Treatments:
• Systemic treatments: Must have discontinued previous systemic treatments for cancer and recovered from the acute effects of therapy. Participants must have discontinued:
• Cytotoxic therapies or targeted agents that are small molecule inhibitors for 5 half-lives or at least 28 days.
• Mitomycin-C or nitrosourea therapy for at least 42 days and biologic agents for at least 28 days.
• Radiation therapy and surgery must be completed 4 weeks prior to therapy, except for limited field radiation therapy, which must be completed 2 weeks before therapy.
• If participant is of reproductive potential, must agree to use medically approved contraceptive precautions during the study and for three months following the last dose of study drug.
• If the participant is a female of childbearing potential, must have had a negative serum or urine pregnancy test within 14 days of the first dose of study drug and must not be breast feeding.

You may not qualify if…

• Must not have taken an unapproved drug as treatment for any indication within the last 28 days prior to starting study treatment.
• Must not have an active symptomatic fungal, bacterial or viral infection, including human immunodeficiency virus (HIV) or Hepatitis A, B, or C.
• Must not have a serious preexisting medical conditions or concomitant disorders.
• Must not have leukemia.
• Must not have QT interval of >470 millisecond.
• Must not have a serious cardiac condition, such as congestive heart failure, unstable angina pectoris, or heart attack within the last 3 months.

Where it is running

• Pinnacle Oncology Hematology — Scottsdale, Arizona, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• The START Center for Cancer Care — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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