A Study of LY3164530 in Participants With Cancer

NCT ID: NCT02221882

Last Updated: 2019-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2017-03-07

Brief Summary

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.

Conditions

Neoplasms; Neoplasm Metastasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LY3164530

LY3164530 in escalating dose cohorts given intravenously (IV) once on Days 1 and 15 or on Days 1, 8, 15, and 22 of a 28-day cycle. Participants may continue to receive study drug until discontinuation criteria are met.

Group Type: EXPERIMENTAL

LY3164530

Intervention Type: DRUG

Administered IV.

Interventions

LY3164530

Administered IV.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

I7H-MC-JNBA

Identifier Type: OTHER

Identifier Source: secondary_id

15279

Identifier Type: -

Identifier Source: org_study_id