An Open-Label, Dose Escalation, Phase I Study of TAK-901 in Adult Patients With Advanced Solid Tumors or Lymphoma
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
- 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
- Left ventricular ejection fraction (LVEF) > or equal to 50% by echocardiogram or
multiple acquisition scan (MUGA).
Patients meeting any of the following exclusion criteria are not to be enrolled in the
- 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
- Treatment with monoclonal antibodies within 28 days before the start of the study
- 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
- 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
- Systemic use of strong CYP3A inhibitors or inducers (as specified in the protocol)
within 14 days before the first dose of study drug.