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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. 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.
. 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.