A Study of LY2523355 in Participants With Breast Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Drug: pegfilgrastim; Drug: filgrastim; Drug: LY2523355; Drug: ixabepilone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01416389

12847

I1Y-MC-JFBE (Other Identifier)

Details and patient eligibility

About

The purpose of the study is to evaluate the anti-tumor activity of LY2523355 relative to ixabepilone for the treatment of metastatic or locally recurrent breast cancer using change in tumor size as a continuous measure of response.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have histologic or cytologic diagnosis of metastatic or locally recurrent breast cancer that is not amenable to therapy given with curative intent.
• Have measurable disease defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 guidelines.
• Have received 2 or more prior standard cytotoxic chemotherapy regimens for metastatic breast cancer and be, in the opinion of the investigator, an appropriate candidate for experimental therapy. Regimens received in the neoadjuvant or adjuvant setting are not counted as prior regimens.
• Have received a prior taxane in the neoadjuvant, adjuvant, or metastatic setting.
• Have recovered from the acute effects of prior chemotherapy, hormonal therapy, and radiation prior to study enrollment.
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
• Have adequate organ function.

Exclusion criteria

• Have Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or greater (moderate or worse) peripheral neuropathy
• Have a second primary malignancy.
• Have symptomatic, untreated, or uncontrolled central nervous system metastases.
• Have received autologous stem cell transplant following high-dose chemotherapy.
• Have serious preexisting medical conditions that in the opinion of the investigator would preclude participation in this study.
• Have active symptomatic fungal, bacterial, and/or known viral infection including active human immunodeficiency virus (HIV) or viral hepatitis.
• Have previously received LY2523355 in another study investigating this agent or therapy with ixabepilone or an ixabepilone-containing regimen.
• Have a history of radiation therapy involving more than 25 percent of the bone marrow.
• Have a Fridericia corrected QT (QTcF) interval of >470 milliseconds (msec) on screening electrocardiogram (ECG).
• Have QRS widening of >120 msec on screening ECG.
• Cannot change or stop taking a strong Cytochrome P450 3A4 (CYP3A4) inhibitor or CYP3A4 inducer per the ixabepilone label.
• Have hypersensitivity to drugs formulated with Cremophor® EL per the ixabepilone label.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

LY2523355 + pegfilgrastim or filgrastim

Experimental group

Description:

LY2523355: Five milligrams per meter squared per day (mg/m\^2/day) (dosage determined by calculating participant's body surface area) administered intravenously as a 1-hour infusion on Days 1, 2, and 3 of a 21-day Cycle for 2 Cycles. Pegfilgrastim or Filgrastim: Dosage is determined by standard of care and is administered intravenously on Day 4 of 21-day Cycle for 2 Cycles. If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.

Treatment:

Drug: filgrastim

Drug: pegfilgrastim

Drug: LY2523355

ixabepilone

Active Comparator group

Description:

Forty milligrams per meter squared per day (mg/m\^2/day) (dosage determined by calculating participant's body surface area) administered intravenously as a 3-hour infusion on Day 1 of a 21-day Cycle for 2 Cycles. If at the end of 2 Cycles the participant was receiving benefit, the participant may have remained on study drug for additional cycles until a criterion for study discontinuation was met.

Treatment:

Drug: ixabepilone