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Clinical Trial 20118

Cancer Type: Thoracic
Interventions:LY3295668 ()

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Alberto Chiappori

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

Phase 1b Study of LY3295668 Erbumine Monotherapy in Patients with Platinum-Sensitive, Extensive-Stage Small-Cell Lung Cancer

Summary

The purpose of this study is to determine the recommended phase 2 dose of LY3295668 erbumine in participants with platinum-sensitive, extensive-stage small-cell lung cancer.

Objective

Primary Objective: To determine the optimal RP2D for LY3295668. Secondary Objectives: To assess the PK of LY3295668 administered as monotherapy, and to document preliminary signs of efficacy of LY3295668 administered as monotherapy. Tertiary/Exploratory Objectives: To assess the relationship between biomarkers and clinical outcome, to assess relationship between LY3295668 exposure and response in terms of safety (for example, ECG parameters) and efficacy, and to estimate the renal clearance of LY3295668 and conduct exploratory metabolite identification on blood and urine samples.

Inclusion Criteria

  • Have histological or cytological evidence of a diagnosis of platinum sensitive small cell lung cancer that is extensive stage.
  • Adequate organ function.
  • Have a performance status (PS) of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  • Have discontinued previous treatments for cancer.
  • Able to swallow capsules.

  • Exclusion Criteria

  • Currently enrolled in a clinical study.
  • Have a serious concomitant systemic disorder.
  • Have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis B or C.
  • Have a significant cardiac condition.
  • Have previously received an aurora kinase inhibitor.