A Study of LY2880070 in Participants With Advanced or Metastatic Cancer

Official Title

A Phase 1b/2a Two-Part Open-Label Multicentre Study to Evaluate the Safety and Efficacy of LY2880070 as Monotherapy and in Combination With Gemcitabine in Patients With Advanced or Metastatic Cancer

Summary:

The main purpose of this two-part study is to evaluate the safety and efficacy of the study drug known as LY2880070 in participants with advanced or metastatic solid tumours.

Trial Description

Primary Outcome:

• Maximum Tolerated Dose(s)

• Number of dose limiting toxicities (DLTs)
• Area under the plasma concentration versus time curve from time zero to 24 hours post-dose (AUC0-24)
• Peak plasma concentration (Cmax)
• Time to reach maximum plasma concentration (tmax)
• Change from baseline in white blood cell count
• Change from baseline in neutrophil count
• Change from baseline in lymphocyte count
• Number of participants with tumour response (objective response rate) as measured by the Response Evaluable Criteria in Solid Tumours (RECIST v.1.1)
• Duration of objective response
• Best response
• Progression free survival
• Overall survival

View this trial on ClinicalTrials.gov