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

An Open-Label, Dose Escalation, Phase I Study of TAK-901 in Adult Patients 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.

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.