a study of e7130 in participants with solid tumors

Conditions: Solid Tumors

Summary: the primary objective of this study is to evaluate the tolerability and safety profile of e7130 in participants with solid tumors.


Eligibility criteria:
inclusion criteria: * participants who have provided voluntary written consent for participation in this clinical study * participants to whom the rules for complying with this clinical study have been adequately explained, and who intend to and can comply with these rules * participants aged greater than or equal to (\>=) 20 years at the time of informed consent * participants with adequate function of major organs * participants with performance status score of 0 to 1 established by the eastern cooperative oncology group (ecog) * participants who are expected to survive for 3 months or longer after starting administration of the investigational drug * washout period required from the end of prior treatment to the first administration of study drug * participants who agree to submit blood samples prior and during study treatment for progressive disease (pd) markers. inclusion criteria (part 2 only): * measurable disease meeting the following criteria: 1. at least 1 lesion of \>=1.0 centimeter (cm) in the longest diameter for a non-lymph node or \>=1.5 cm in the short-axis diameter for a lymph node that is serially measurable according to response evaluation criteria in solid tumours (recist) 1.1 using computerized tomography/magnetic resonance imaging (ct/mri). 2. lesions that have had external beam radiotherapy (ebrt) or locoregional therapies such as radiofrequency (rf) ablation must show evidence of progressive disease to be deemed a target lesion. exclusion criteria: * medical history of clinically significant cardiovascular impairment * serious concomitant systemic infection requiring medical treatment (including bacterial infection and fungal infection) * participants who test positive for human immunodeficiency virus (hiv antibody) * active viral hepatitis (b or c) as demonstrated by positive serology or requiring treatment hepatitis b surface antigen (hbsag), anti-hepatitis b surface antibody (anti-hbs)/hepatitis b core antibody (hbcab) and anti-hepatitis c virus (hcv) antibody test. * effusion requiring drainage * participants whose toxicity of previous treatment has not recovered to grade 1 or lower (except for alopecia and hemoglobin) * other active malignancy * females who are breastfeeding or pregnant at screening or baseline (as documented by a positive beta-human chorionic gonadotropin \[ß-hcg\] or human chorionic gonadotropin \[hcg\]). * women of childbearing potential or men of impregnate potential who don't agree that both the participant and his/her partner will use a medically effective method for contraception during the study and after study drug discontinuation (male; 90 days, female; 60 days) * known intolerance to the study drug or any of the excipients * any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in the study * scheduled for surgery during the study * diagnosed with meningeal carcinomatosis * participants with brain or subdural metastases are not eligible.

Keywords: solid tumors squamous cell carcinoma of the head and neck urothelial carcinoma