Phase I Study of Indibulin in Combination With Erlotinib in Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00591383|
Recruitment Status : Unknown
Verified July 2012 by Ziopharm.
Recruitment status was: Active, not recruiting
First Posted : January 11, 2008
Last Update Posted : July 19, 2012
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors||Drug: indibulin Drug: erlotinib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Indibulin in Combination With Erlotinib in Advanced Solid Tumors|
|Study Start Date :||January 2008|
|Estimated Primary Completion Date :||June 2013|
|Estimated Study Completion Date :||June 2013|
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.
- toxicities [ Time Frame: 6 months ]
- pharmacokinetics [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00591383
|United States, Texas|
|Houston, Texas, United States|
|Study Director:||Jonathan Lewis, MD||Ziopharm|