A Study of LY3164530 in Participants With Cancer

Lilly

Status and phase: Completed; Phase 1

Conditions: Neoplasms; Neoplasm Metastasis

Treatments: Drug: LY3164530

Study type: Interventional

Funder types: Industry

Identifiers

NCT02221882

15279

I7H-MC-JNBA (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

29 participants in 1 patient group

LY3164530

Experimental group

Description:

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.

Treatment:

Drug: LY3164530