Brief Title
A Phase 1 Dose Escalation Study of TAK-901 in Subjects With Advanced Hematologic Malignancies
Official Title
A Phase 1 Dose Escalation Study of TAK-901 in Subjects With Advanced Hematologic Malignancies
Brief 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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
To determine the maximum tolerated dose(MTD)of TAK-901 in subjects with advanced hematologic malignancies.
Secondary Outcome
To evaluate the pharmacokinetic profile of TAK-901 and its primary metabolite (M-I).
Condition
Acute Myeloid Leukemia
Intervention
TAK-901
Study Arms / Comparison Groups
1
Description: TAK-901
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
31
Start Date
March 2009
Completion Date
March 2013
Primary Completion Date
September 2012
Eligibility Criteria
Main Inclusion Criteria:
1. 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:
1. Acute myelogenous leukemia
2. Acute lymphoblastic leukemia
3. Chronic myelogenous leukemia (CML) (chronic phase, accelerated phase, or blast
crisis)
4. Chronic lymphocytic leukemia
5. Multiple myeloma
6. Waldenstrom's macroglobulinemia
7. Intermediate or high risk myelodysplastic syndrome
8. One of the following myeloproliferative disorders:
- Philadelphia chromosome-negative CML (including blast phase).
- All subtypes of myeloid metaplasia with myelofibrosis.
- Advanced polycythemia vera in the spent phase (ie, presence of anemia).
9. Non-Hodgkins lymphoma
2. 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.
3. 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.
4. 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.
5. 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.
6. The subject is aged 18 years or older.
7. The subject weighs at least 45 kg.
8. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤
2.
9. The subject has adequate liver and kidney function.
10. 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:
1. 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.
2. 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.
3. The subject has any evidence of acute or chronic graft versus host disease.
4. The subject has a history of hypersensitivity or allergic reactions attributed to
compounds of similar chemical composition to TAK-901 or its excipient, Captisol.
5. The subject is pregnant or lactating.
6. 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.
7. The subject's electrocardiogram demonstrates an abnormal QT interval , as defined by
the protocol.
8. The subject requires dialysis.
9. The subject is on systemic anticoagulation therapy.
10. The subject has an uncontrolled intercurrent illness as defined in the protocol.
11. The subject is known to have human immunodeficiency virus (HIV) infection or chronic
hepatitis B or C.
12. The subject has a currently active second malignancy other than nonmelanoma skin
cancer or in situ carcinoma of the cervix. A malignancy is considered to be currently
active if the subject is receiving ongoing therapy or has been in remission for less
than 2 years prior to the first dose of study drug.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Medical Monitor, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00807677
Organization ID
TAK-901_101
Responsible Party
Sponsor
Study Sponsor
Millennium Pharmaceuticals, Inc.
Study Sponsor
Medical Monitor, Study Director, Millennium Pharmaceuticals, Inc.
Verification Date
July 2013