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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAK-901 Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-901 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To identify the MTD of TAK-901 administered as either a 3-hour or 1-hour infusion. | 12 months | |
| To adaptively adjust the estimate of the MTD of TAK-901 from the escalation phase in an expansion cohort of subjects. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetic profile of TAK-901 and its primary metabolite (M-I). | 12 months | |
| To evaluate disease response. | 12 months | |
| To investigate the effect of TAK-901 on tumor proliferation. |
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Inclusion Criteria:
Each patient must meet all of the following criteria to be enrolled in the study:
Exclusion Criteria:
Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Millennium Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan | Ann Arbor | Michigan | United States | |||
| Karmanos Cancer Center |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C583854 | TAK-901 |
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|
| 12 months |
| Detroit |
| Michigan |
| 48201 |
| United States |
| Fox Chase Cancer Center | Rockledge | Pennsylvania | 19046 | United States |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |