Status:
COMPLETED
Study of TAK-901 in Adults With Advanced Solid Tumors or Lymphoma
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Advanced Solid Tumors
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is being conducted to evaluate the safety profile and the Maximum Tolerated Dose (MTD) of TAK-901 in adult patients with advanced solid tumors or lymphoma. This study will help to identify ...
Eligibility Criteria
Inclusion
- Each patient must meet all of the following criteria to be enrolled in the study:
- ECOG performance status of \< or equal to 2.
- Diagnosis of solid tumor malignancy or lymphoma for which standard treatment is no longer effective.
- Have a radiographically or clinically evaluable tumor or lymphoma.
- Measurable disease as described in the protocol.
- Suitable venous access for the study-required blood sampling.
- Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse.
- Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse.
- Voluntary written consent.
- Weigh at least 45 kg.
- Recovered from the reversible effects of prior antineoplastic therapy.
- Meet clinical laboratory values during the screening period as specified in the protocol.
- Left ventricular ejection fraction (LVEF) \> or equal to 50% by echocardiogram or multiple acquisition scan (MUGA).
Exclusion
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- Diagnosis of primary CNS malignancy or carcinomatous meningitis.
- Patient has symptomatic brain metastasis.
- Prior bone allogeneic bone marrow or stem cell transplant.
- Prior radiotherapy involving \> or equal to 30% of the hematopoietically active bone marrow, within 21 days before the start of the study drug.
- Systemic antineoplastic therapy within 28 days before the start of the study drug, except for luteinizing hormone-releasing-hormone (LHRH) agonist therapy.
- Exposure to nitrosureas or mitomycin C within 42 days before the start of the study drug.
- Treatment with monoclonal antibodies within 28 days before the start of the study drug.
- Known allergy or hypersensitivity to compounds of similar chemical composition to TAK-901 or its excipient, Captisol.
- Female patients who are lactating or who have a positive serum pregnancy test during the screening period or a positive serum pregnancy test during the screening period.
- Myocardial infarction within 6 months before enrollment.
- Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure, angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- Abnormalities on 12-lead electrocardiogram (ECG) as specified in the protocol.
- Infection requiring systemic anti-infective therapy within 14 days before the start of study drug.
- Known human immunodeficiency virus (HIV)positive, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection.
- Diagnosed or treated for another malignancy within 2 years before the start of study drug or previously diagnosed with another malignancy and have any evidence of residual disease.
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment.
- Treatment with any investigational products within 28 days before the first dose of study drug.
- Systemic use of strong CYP3A inhibitors or inducers (as specified in the protocol) within 14 days before the first dose of study drug.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00935844
Start Date
October 1 2009
End Date
November 1 2011
Last Update
December 8 2011
Active Locations (3)
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1
The University of Michigan
Ann Arbor, Michigan, United States
2
Karmanos Cancer Center
Detroit, Michigan, United States, 48201
3
Fox Chase Cancer Center
Rockledge, Pennsylvania, United States, 19046