syb c-0501(oral bendamustine) in patients with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: this study is an open-label, multicenter, phase 1 study of syb c-0501 by continuous daily oral administration in patients with advanced solid tumors, who have previously received anticancer therapy and consists of two parts. part 1 is a dose escalation study to evaluate tolerability of syb c-0501 in the patients, and to find the maximum tolerated dose (mtd), recommended dose (rd) and optimum dosing schedule. part 2 is being done to evaluate safety and anti-tumor activity of syb c-0501 preliminarily at rd, and to assess its target cancer exploratory.


Eligibility criteria:
inclusion criteria: * 20 years of age or greater at the time of informed consent * part 1: patients with histologically or cytologically confirmed advanced solid tumors refractory to standard therapies or without standard therapies. * part 2: patients with advanced solid tumors\* refractory to standard therapies or without standard therapies. * \*metastatic breast cancer, small cell lung cancer and other tumors decided based on the part 1 results * ecog performance status 0-1 * patients with adequate bone marrow, liver, renal, cardiac and pulmonary function as assessed by the following: * absolute neutrophil count (anc) ≥ 1500/μl, who has not received supportive care of treatment with gcs within 2 weeks before the entry * platelet count ≥ 100,000/μl and hemoglobin ≥ 9g/dl in patients received no blood transfusions within 2 weeks before the study entry * serum creatinine ≤ 1.5 x upper limit normal (uln) or estimated creatinine clearance ≥ 50 ml/min using cockcroft-gault equation * serum total bilirubin ≤ 1.5 x uln in patients not suffering from gilbert's syndrome * alt and ast ≤ 3.0 x uln (≤ 5.0 x uln if liver lesions) * 12-lead ecg normal * lvef ≥ 55% by echocardiography * spo2 ≥ 95% or pao2 ≥ 65mmhg * acute toxicity in prior treatment has recovered to baseline or ctcae grade 0-1 except the adverse events that, in the judgment of the investigator or sub-investigator, would not provide safety risks in the study. * serum/urine pregnancy tests performed before the study entry are negative. * male and female patients of childbearing potential should give their consent to use adequate contraceptive measures during the study and 180 days after completing study treatment. * provision of written, signed and dated informed consent by the patient or legally acceptable representative after the receipt of adequate information regarding the study * ability to understand participation in the study, visiting/treatment plan, sampling/analyses and other study procedures; and willingness to follow them exclusion criteria: * active, uncontrollable or symptomatic metastatic tumors in cns * complications of interstitial lung disease, pulmonary fibrosis and emphysema diagnosed by chest-x ray or ct scan * medical history of radiation, idiopathic or drug-induced pneumonitis * major surgery within 4 weeks before study entry or planning it within 4 weeks * treatment with immunotherapy, therapeutic antibody or biologics within 4 weeks or their 5 half-lives before study entry, whichever is longer * treatment with cytocidal chemotherapy or hormonal therapy within 14 days * radiotherapy within 4 weeks before study entry * palliative radiotherapy to control metastatic bone pain within 7 days before study entry * malabsorption syndrome or full/partial gastric resection * patients intolerable to oral administration in the judgment of the investigator or sub-investigator * patients under following medical treatment * anticancer therapy approved for advanced cancers * study treatment in other clinical trials * active infection including hepatitis b, hepatitis c and human immunodeficiency virus (hiv) detected in blood test * lactating women * medical history of allergy to the agents similar to the investigational drug such as alkylating agents or purine nucleoside derivatives * medical history of allergy to polyoxyl 40 hydrogenated castor oil or gelatin capsule * severe acute or chronic physical/mental condition or laboratory abnormalities which could interfere with evaluation of study treatment or results, or which is likely to progress/worsen due to the participation in the study or administration of syb c-0501 * any condition that, in the opinion of the investigator or sub-investigator, makes the patient inappropriate for the study participation.