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The purpose of this study is to determine the maximum tolerated dose (MTD) of TAK-901 in subjects with advanced hematological malignancies, and to further assess the safety and tolerability of TAK-901 at or below the MTD in an expanded cohort of subjects in order to select a dose for future studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | TAK-901 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-901 | Drug | TAK-901 will be administered via IV infusion over a 3-hour period on Days 1,4,8,11,15,18,22, and 25 of each 28-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine the maximum tolerated dose(MTD)of TAK-901 in subjects with advanced hematologic malignancies. | Duration of the study | |
| To further assess the safety and tolerability of TAK-901 at or below the MTD in an expanded cohort of subjects in order to select a dose for future studies. | Duration of study |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the pharmacokinetic profile of TAK-901 and its primary metabolite (M-I). | Duration of the study | |
| To make a preliminary assessment of the clinical activity of TAK-901. | Duration of therapy |
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Main Inclusion Criteria:
The subject has one of the following confirmed diseases that is refractory to or relapsed from established therapies. Note: A subject with one of these disease who is intolerant (as defined in the protocol) to established therapies is also allowed:
Acute myelogenous leukemia
Acute lymphoblastic leukemia
Chronic myelogenous leukemia (CML) (chronic phase, accelerated phase, or blast crisis)
Chronic lymphocytic leukemia
Multiple myeloma
Waldenstrom's macroglobulinemia
Intermediate or high risk myelodysplastic syndrome
One of the following myeloproliferative disorders:
Non-Hodgkins lymphoma
The interval between the last prior treatment and the start of study drug administration is at least 30 days for radiotherapy, at least 14 days for cytotoxic chemotherapy (42 days for nitrosureas or mitomycin C), and at least 5 half-lives for noncytotoxic agents. The only exception is hydroxyurea, which can be used prior to starting study drug and during Cycle 1, as defined in the protocol.
For subjects with prior autologous bone marrow or peripheral blood stem cell transplantation, the interval between transplant and the start of study drug administration is at least 30 days.
For subjects with prior allogeneic bone marrow or peripheral blood stem cell transplantation, the interval between transplant and the start of study drug administration is at least 90 days.
If taking steroids chronically, the subject has been receiving a stable steroid dose for at least 21 days prior to the start of study drug administration, and the daily steroid dose does not exceed the equivalent of 20 mg prednisone.
The subject is aged 18 years or older.
The subject weighs at least 45 kg.
The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
The subject has adequate liver and kidney function.
The subject has adequate heart function (left ventricular ejection fraction ≥ 50%).
Main Exclusion Criteria:
Any subject who meets any of the following criteria will not qualify for entry into the study:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Millennium Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| To make a preliminary assessment of the effects of TAK-901 on pharmacodynamic biomarkers. | Duration of therapy |
| To make a preliminary assessment of the association between selected genetic markers and TAK-901 response and/or pharmacokinetic parameters. | Duration of therapy |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D009101 | Multiple Myeloma |
| D008258 | Waldenstrom Macroglobulinemia |
| D009190 | Myelodysplastic Syndromes |
| D055728 | Primary Myelofibrosis |
| D008228 | Lymphoma, Non-Hodgkin |
| D001752 | Blast Crisis |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015448 | Leukemia, B-Cell |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D008223 | Lymphoma |
| D002471 | Cell Transformation, Neoplastic |
| D063646 | Carcinogenesis |
| D009385 | Neoplastic Processes |
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| ID | Term |
|---|---|
| C583854 | TAK-901 |
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