NCT00738751

Phase I Study of LBH589 & Erlotinib for Advanced Aerodigestive Tract Cancers

Phase I Study of LBH589 in Combination With Erlotinib for Advanced Aerodigestive Tract Cancers (CLBH5889CUS11T)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of the study is to: * Determine the safety and tolerability of erlotinib and LBH589B. * Establish a recommended phase II expansion dosing of LBH589B and erlotinib in patients with advanced aerodigestive tract cancers.

Conditions

• Lung Cancer
• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	Panobinostat (LBH589)	Panobinostat was taken twice weekly, for 2 out of 3 weeks of each cycle. Each cycle was defined as a 21-day period. Four dose levels of panobinostat in combination with erlotinib were planned: 1) dose level 1 (DL1) = panobinostat 20 mg by mouth (PO) twice weekly for 2 out of 3 weeks + erlotinib 100 mg PO daily; 2) dose level 2 (DL2) = panobinostat 30 mg and erlotinib 100 mg; 3) dose level 3 (DL3) = panobinostat 30 mg and erlotinib 150 mg; and 4) dose level 4 (DL4) = panobinostat 40 mg and erlotinib 150 mg. Doses were not escalated over the course of treatment of an individual participant.
DRUG	erlotinib	Erlotinib was taken daily without interruption. Each cycle was defined as a 21-day period. Panobinostat was taken twice weekly, for 2 out of 3 weeks of each cycle. Four dose levels of panobinostat in combination with erlotinib were planned: 1) dose level 1 (DL1) = panobinostat 20 mg by mouth (PO) twice weekly for 2 out of 3 weeks + erlotinib 100 mg PO daily; 2) dose level 2 (DL2) = panobinostat 30 mg and erlotinib 100 mg; 3) dose level 3 (DL3) = panobinostat 30 mg and erlotinib 150 mg; and 4) dose level 4 (DL4) = panobinostat 40 mg and erlotinib 150 mg. Doses were not escalated over the course of treatment of an individual participant.

Timeline

• Start date: 2008-11-01
• Primary completion: 2013-08-01
• Completion: 2015-02-01
• First posted: 2008-08-20
• Last updated: 2015-02-04

Locations

1 site across 1 country: United States