study of tak-901 in adults with advanced solid tumors or lymphoma

Conditions: Advanced Solid Tumors; Lymphoma

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 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.

Keywords: advanced solid tumors lymphoma