A Phase 1 Dose Escalation Study of TAK-901 in Subjects With Advanced Hematologic Malignancies
NCT00807677 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31
Last updated 2013-07-02
Summary
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.
Conditions
- Acute Myeloid Leukemia
- Acute Lymphoblastic Leukemia
- Chronic Myelogenous Leukemia
- Chronic Lymphocytic Leukemia
- Multiple Myeloma
- Waldenstrom's Macroglobulinemia
- Myelodysplastic Syndrome
- Philadelphia Chromosome-negative CML
- Myeloid Metaplasia
- Myelofibrosis
- Advanced Polycythemia
- Non-Hodgkins Lymphoma
Interventions
- DRUG
-
TAK-901
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.
Sponsors & Collaborators
-
Millennium Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Medical Monitor · Millennium Pharmaceuticals, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-03-31
- Primary Completion
- 2012-09-30
- Completion
- 2013-03-31
Countries
- United States
Study Locations
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