Study of TAK-901 in Adults With Advanced Solid Tumors or Lymphoma

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 the recommended phase 2 dose and infusion duration, and describe the pharmacokinetics of TAK-901.


Eligibility Criteria:
Inclusion Criteria:

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 Criteria:

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.