Phase 2 Completed N=39 Randomized Treatment

A Study of LY2523355 in Participants With Breast Cancer

Source: ClinicalTrials.gov NCT01416389 ↗

Enrolled (actual)

Serious AEs

23.1%

Results posted

Dec 2017

Primary outcomePrimary: Change in Tumor Size (CTS) From Baseline to the End of Cycle 2 — -0.0; -0.1 log ratio of end of Cycle 2 to baseline — p=0.344

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Tumor Size (CTS) From Baseline to the End of Cycle 2	-0.0; -0.1	0.344
SECONDARY Percentage of Participants Achieving an Overall Response (Overall Response Rate)	3.8; 7.7	0.608
SECONDARY Progression-free Survival (PFS)	1.71; 2.76	—
SECONDARY Percentage of Participants Achieving a Clinical Benefit (Clinical Benefit Rate)	46.2; 61.5	0.365
SECONDARY Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355	161; 150	—
SECONDARY Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LSN2546307	5.08; 5.53	—
SECONDARY Pharmacokinetics, Intracycle Accumulation Ration (Ra) of LY2523355	0.92	—

Eligibility Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT01416389). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.