A Study of Tesetaxel Plus Capecitabine in Patients With Solid Tumors
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|ClinicalTrials.gov Identifier: NCT01315431|
Recruitment Status : Unknown
Verified July 2012 by Genta Incorporated.
Recruitment status was: Active, not recruiting
First Posted : March 15, 2011
Last Update Posted : July 24, 2012
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: Tesetaxel plus capecitabine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Tesetaxel Administered in Combination With Capecitabine to Subjects With Solid Tumors|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||August 2012|
|Estimated Study Completion Date :||October 2012|
Drug: Tesetaxel plus capecitabine
Study medication, which will include tesetaxel capsules and capecitabine tablets, will be administered orally for two 21-day cycles. In each cycle, tesetaxel will be administered at a dose of 27 mg/m2 on Day 1, and capecitabine will be administered in Cohort 1 at a dose of 2000 mg/m2/day and in Cohort 2 at a dose of 1750 mg/m2/day (in 2 equally divided doses) on Day 1 through Day 14.
At the conclusion of Cycle 2, patients who, in the opinion of the investigator, appear to have benefitted from protocol therapy may receive up to 6 additional cycles under a separate protocol.
- Incidence of adverse events [ Time Frame: Through 30 days following the last dose of study medication ]Percentage of subjects with adverse events
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): NCT01315431
|United States, Tennessee|
|The West Clinic|
|Memphis, Tennessee, United States, 38120|
|Principal Investigator:||Lee S Schwartzberg, MD, FACP||The West Clinic|