Phase I Trial of ZIO-101 in Patients With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00509782|
Recruitment Status : Completed
First Posted : July 31, 2007
Last Update Posted : August 1, 2012
- To determine the toxicities and maximum tolerated dose (MTD) of ZIO-101 when administered intravenously once a day for 5 consecutive days every 4 weeks in subjects with advanced solid tumors.
- To determine the pharmacokinetic profile of ZIO-101 when administered intravenously once a day for 5 consecutive days every 4 weeks.
1. To determine the anti-tumor effects of ZIO-101.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Drug: ZIO-101||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of ZIO-101 in Patients With Solid Tumors|
|Study Start Date :||May 2005|
|Primary Completion Date :||April 2008|
|Study Completion Date :||April 2008|
Starting Dose 78 mg/m^2 intravenously daily for 5 consecutive days repeated every 4 weeks.
- Maximum tolerated dose (MTD) [ Time Frame: Daily for 5 consecutive days repeated every 4 weeks for 1 cycle; evaluation of 4-6 dose escalations to determine an MTD ]
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): NCT00509782
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Razelle Kurzrock, MD||M.D. Anderson Cancer Center|