Phase II Study of Tesetaxel in Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT01064713|
Recruitment Status : Completed
First Posted : February 8, 2010
Last Update Posted : November 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Advanced Melanoma Cancer||Drug: Tesetaxel||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Tesetaxel as Second-line Therapy for Subjects With Advanced Melanoma and Normal Serum LDH|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||October 2014|
Therapy initiated at a flat dose of 40 mg for subjects in Cohort A and at a flat dose of 50 mg for subjects in Cohort B. Tesetaxel administered orally once every 21 days until the subject meets a withdrawal criterion or initiates nonstudy therapy for melanoma. Duration of protocol therapy will not exceed 12 months.
Cohort A: 40 mg by mouth every 21 days.
Cohort B. 50 mg by mouth every 21 days.
- Response rate (ie, the percentage of subjects with a confirmed complete or partial response) [ Time Frame: Baseline to Day 84 ]Determination of response performed according to the revised Response Evaluation Criteria in Solid Tumors (RECIST).
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): NCT01064713
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Agop Y. Bedikian, MD, BS||M.D. Anderson Cancer Center|