A Phase 1 Dose Escalation Study of TAK-901 in Subjects With Advanced Hematologic Malignancies (NCT00807677) | Clinical Trial Compass
CompletedPhase 1
A Phase 1 Dose Escalation Study of TAK-901 in Subjects With Advanced Hematologic Malignancies
United States31 participantsStarted 2009-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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:
✓. Intermediate or high risk myelodysplastic syndrome
Exclusion criteria
✕. The subject has a platelet count (untransfused) \< 50,000/mm3 and/or an absolute neutrophil count \< 1000/mm3 that is not caused by the underlying disease infiltrating the bone marrow.
✕. The subject has evidence of active malignancy in the central nervous system (CNS)or has had CNS involvement documented within the past 90 days. Subjects who are receiving maintenance intrathecal chemotherapy for previous CNS involvement but have no current evidence of disease are allowed if the CNS involvement was documented more than 90 days ago.
✕. The subject has any evidence of acute or chronic graft versus host disease.
✕
What they're measuring
1
To determine the maximum tolerated dose(MTD)of TAK-901 in subjects with advanced hematologic malignancies.
Timeframe: Duration of the study
2
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.
. The subject has a history of hypersensitivity or allergic reactions attributed to compounds of similar chemical composition to TAK-901 or its excipient, Captisol.
✕. The subject is pregnant or lactating.
✕. The subject has had a myocardial infarction, cerebrovascular accident, transient ischemic attack, clinically significant ventricular arrhythmia, or pulmonary embolus within 6 months prior to the start of study drug administration.
✕. The subject's electrocardiogram demonstrates an abnormal QT interval , as defined by the protocol.