NCT01115803

A Study of LY2584702 With Erlotinib or Everolimus in Participants With Solid Tumors

A Phase 1b Trial of LY2584702 in Combination With Erlotinib or Everolimus in Patients With Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study I3G-MC-JGCB (JGCB) is a multicenter, nonrandomized, open-label, dose-escalation Phase 1b study of LY2584702 in combination with either erlotinib or everolimus.

Detailed description

Study JGCB will consist of the following parts: Part 1 - Dose Escalation to maximum tolerated dose in each arm. Arm A - LY2584702 + Erlotinib in participants with advanced or metastatic cancer. Arm B - LY2584702 + Everolimus in participants with advanced or metastatic cancer. Part 2 - Dose Confirmation of maximum tolerated dose from each arm in Part 1. Arm A - LY2584702 + Erlotinib in participants with advanced or metastatic non-small cell lung cancer. Arm B - LY2584702 + Everolimus in participants with advanced renal cell carcinoma after treatment failure with sunitinib or sorafenib, or advanced neuroendocrine tumors.

Conditions

• Metastases, Neoplasm
• Carcinoma, Non-small Cell Lung
• Renal Cell Carcinoma
• Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	LY2584702	Supplied as 25 milligrams (mg) and 100 mg capsules, administered orally for two 28-day cycles.
DRUG	Erlotinib	Supplied as 25 mg, 100 mg, or 150 mg tablets, administered orally, daily for two 28-day cycles. Starting dose is 150mg. Doses may be decreased in 50mg increments if necessary due to toxicity.
DRUG	Everolimus	Supplied as 5 mg or 10 mg tablets, administered orally, daily for two 28-day cycles.

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-05-04
• Last updated: 2019-02-05
• Results posted: 2019-01-18

Locations

3 sites across 2 countries: United States, France