Phase I Study of Indibulin in Combination With Erlotinib in Advanced Solid Tumors
Single arm, open label, Phase I, dose-escalation study of indibulin in combination with erlotinib in subjects with advanced histologically confirmed, solid tumors for which no standard therapy exists and for whom treatment with erlotinib is considered medically acceptable.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Indibulin in Combination With Erlotinib in Advanced Solid Tumors|
- toxicities [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- pharmacokinetics [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: Single Arm
Once Maximum Tolerated Dose (MTD) is determined an expanded cohort will be enrolled to evaluate efficacy.
indibulin, dose escalation, 200 mg - 600 mg. Taken twice every day.
Other Name: ZIO-301Drug: erlotinib
erlotinib taken at 150 mg every morning with food.