NCT01115751

A Study in Patients With Advanced or Metastatic Cancer

A Phase I Trial of Single-Agent LY2780301 in Patients With Advanced or Metastatic Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study JWAA is a multicenter, nonrandomized, open-label, dose-escalation Phase 1 study of oral LY2780301 in patients with advanced solid tumors.

Detailed description

JWAA will consist of the following treatment phases parts: Part A - Dose escalation phase using a once-daily dosing schedule. Part B - Dose escalation phase using a twice-daily dosing schedule. Part C - Dose expansion phase using the maximum tolerated dose from either Part A or Part B.

Conditions

• Metastases, Neoplasm

Interventions

Type	Name	Description
DRUG	LY2780301	Administered orally, daily for two 28-day cycles. Starting dose is 100mg. The dose will be subsequently increased to 200mg, 300mg, 400mg, 500mg, and 600mg if no dose limiting toxicity is observed at the prior dose levels. Patients who, in the opinion of the investigator, demonstrate clinical benefit may receive treatment beyond two cycles until disease progression.

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2010-05-04
• Last updated: 2012-07-31

Locations

2 sites across 1 country: Spain