Safety, Tolerability and Pharmacokinetics of Oral Tablet of Irinotecan in Adult Patients With Solid Tumors

Inclusion Criteria: * Signed written Informed Consent * 18 years of age or older * Capable of understanding the protocol requirements and risk associated with the study * Patients must have histological confirmed malignancy (solid tumor) that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective * Patients with either measurable disease according to RECIST 1.1 or non-measurable disease * Performance status 0-1 (ECOG) * Life expectancy ≥ 3 months * Coagulation INR \< 1.3 and APTT within normal limits * WBC ≥ 3000/mm3 * Absolute neutrophil count ≥ 1500/mm3 * Hemoglobin ≥ 6.0 mmol/L * Platelet count ≥ 100.000/mm3 * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN AST and ALT ≤ 2.5 times ULN. For patients with liver metastasis adequate hepatic function is defined by aspartate aminotransferase (AST) ≤ 5 x ULN and alanine aminotransferase ALT ≤ 5 x ULN * No severe or uncontrolled renal condition (creatinine ≤ than 1.5 ULN) * No significant cardiovascular disease (New York Heart Association Class III and IV) * No other severe cardiac condition not defined above * No significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year prior for patients to be enrolled and treated in combination with oral capecitabine * No severe or uncontrolled pulmonary condition * No known prior hypersensitivity reaction to irinotecan * No known prior hypersensitivity to capecitabine or 5-fluorouracil for patients to be enrolled and treated in combination with oral capecitabine * No chronic enteropathy (e.g. active inflammatory bowel disease, extensive intestinal resection or chronic diarrhea) * No bowel obstruction or sub-obstruction * No prior history of intestinal malabsorption * Patients have to be able to swallow normally and have to be willing to comply with the intake of tablets * No psychiatric condition that would preclude study participation * No co-existing active infection requiring antibiotics or any co-existing medical conditions likely to interfere with study procedures * No other condition that will preclude study participation * A negative pregnancy test for women of childbearing potential. For men and women of child-producing potential, the use of effective contraceptives methods during the study and at least 3 months after discontinuations of the study drug is required. * Not pregnant or nursing * Peripheral neuropathy NCI CTCAE grade less than 2 for patients to be enrolled and treated in combination with oral capecitabine * The patient is willing and able to comply with hospitalization for treatment and scheduled follow-up visits and examinations Exclusion Criteria: * Simultaneous participation in any other study involving investigational drugs or having participated in a study within 4 weeks prior to start of study treatment * Symptomatic brain metastases * Intake of any prohibited concomitant medication * Known Dihydropyrimidine dehydrogenase (DPD) deficiency for patients to be enrolled and treated in combination with oral capecitabine.