Open-Label Study of TPI 287 for Patients With Metastatic Melanoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01340729|
Recruitment Status : Withdrawn
First Posted : April 25, 2011
Last Update Posted : April 5, 2013
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Melanoma||Drug: TPI 287||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Open-Label Study of TPI 287 for Patients With Metastatic Melanoma|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||September 2016|
Experimental: TPI 287
Starting dose TPI 287 of 125 mg/m2 intravenous (IV) for 3 weeks of 4 week schedule.
Drug: TPI 287
Starting dose of 125 mg/m2 IV via a central venous catheter (CVC) or a peripherally inserted central catheter (PICC) line over 60 minutes (+/- 10 minutes) on Days 1, 8, and 15 (+/- 2 days) of each 28 day (+/- 3 days) study cycle. The 4-week schedule composes one cycle.
- Maximum Tolerated Dose (MTD) TPI 287 administered weekly for three weeks out of every four in patients with metastatic melanoma [ Time Frame: With each 28 day cycle and DLTs at 12 weeks ]Optimal dose (MTD) of TPI 287 for the Phase II part of the study defined as level at which no dose limiting toxicities (DLTs) are experienced (3+3 dose escalation algorithm). DLT is defined as Grade 3 or higher toxicity that is reasonably likely to be associated with study treatment at 12 weeks.
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): NCT01340729
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Agop Y. Bedikian, MD, BS||UT MD Anderson Cancer Center|