Study of TAK-901 in Adults With Advanced Solid Tumors or Lymphoma
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|ClinicalTrials.gov Identifier: NCT00935844|
Recruitment Status : Completed
First Posted : July 9, 2009
Last Update Posted : December 8, 2011
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors Lymphoma||Drug: TAK-901||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Dose Escalation, Phase I Study of TAK-901 in Adult Patients With Advanced Solid Tumors or Lymphoma|
|Study Start Date :||October 2009|
|Primary Completion Date :||August 2011|
|Study Completion Date :||November 2011|
|Experimental: TAK-901 Arm||
This study consists of three sequential parts.
Part 1: Escalating doses of TAK-901 will be administered via IV infusion over a 3-hour period on Days 1, 4, 8, 11, 15, and 18 of each 28-day cycle.
Part 2: Escalating doses of TAK-901 (starting at one-third of the dose identified as the MTD in Part 1) will be administered as a 1-hour infusion on Days 1, 4, 8, 11, 15, and 18 of each 28-day cycle.
Part 3: TAK-901 will be administered to approximately 20 patients using the dose identified as the MTD in the escalation phase. The infusion duration of TAK-901 will be determined after completion of Part 2.
- To identify the MTD of TAK-901 administered as either a 3-hour or 1-hour infusion. [ Time Frame: 12 months ]
- To adaptively adjust the estimate of the MTD of TAK-901 from the escalation phase in an expansion cohort of subjects. [ Time Frame: 12 months ]
- To evaluate the pharmacokinetic profile of TAK-901 and its primary metabolite (M-I). [ Time Frame: 12 months ]
- To evaluate disease response. [ Time Frame: 12 months ]
- To investigate the effect of TAK-901 on tumor proliferation. [ Time Frame: 12 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): NCT00935844
|United States, Michigan|
|The University of Michigan|
|Ann Arbor, Michigan, United States|
|Karmanos Cancer Center|
|Detroit, Michigan, United States, 48201|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Rockledge, Pennsylvania, United States, 19046|
|Study Director:||Medical Monitor||Millennium Pharmaceuticals, Inc.|