Study of TAK-901 in Adults With Advanced Solid Tumors or Lymphoma
This study is being conducted to evaluate the safety profile and the Maximum Tolerated Dose (MTD) of TAK-901 in adult patients with advanced solid tumors or lymphoma. This study will help to identify the recommended phase 2 dose and infusion duration, and describe the pharmacokinetics of TAK-901.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Dose Escalation, Phase I Study of TAK-901 in Adult Patients With Advanced Solid Tumors or Lymphoma|
- To identify the MTD of TAK-901 administered as either a 3-hour or 1-hour infusion. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- To evaluate the pharmacokinetic profile of TAK-901 and its primary metabolite (M-I). [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- To evaluate disease response. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- To investigate the effect of TAK-901 on tumor proliferation. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Study Completion Date:||November 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
|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.
|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.|