Health Condition 1: null- Squamous Cell Carcinoma of Head and Neck
Conditions
Interventions
Intervention1: TK-112690: Dose cohorts will receive MTX at a dose of 60 mg/m2 administered weekly for 4 consecutive weeks as an iv infusion. TK-112690 will be administered as a one-hour infusion one h
Sponsors
Tosk Inc
Eligibility
Inclusion criteria
Inclusion criteria: • Male and female subjects over 18 years old with a histologically or cytologically confirmed diagnosis of locally advanced, recurrent or metastatic SCCHN, any stage of disease. • No prior systemic treatments for cancer (chemotherapy and/or radiotherapy) 4 weeks prior to screening. • No other concurrent, active, invasive malignancies. • An Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. • Must have a life expectancy of at least 6 months. • History of brain metastases allowed if disease has stabilized or improved after radiation and/or craniotomy. • No active angina or uncontrolled arrhythmia. • No detectable infection including hepatitis B/C and HIV. • No other concurrent, active, invasive malignancies • Not pregnant or nursing. Women of childbearing potential must have a negative urine pregnancy test at screening and on the day before dosing and must use medically acceptable methods of birth control. Acceptable methods of birth control include oral or transdermal contraceptives, condoms, spermicidal foam, IUD, progestin implant or injection, abstinence, vaginal ring, or sterilization of partner. The reason for non-childbearing potential, such as bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or post-menopausal for >= 1 year, must be specified on the patientâ??s medical history file and CRF. • Must have adequate organ and immune function as indicated by the following laboratory values: Parameter Laboratory Values Serum creatinine £1.5 x ULN Estimated creatinine clearance ³45 mL/min Total bilirubin £2.0 mg/dL (£34.2 mmol/L) AST & ALT £3 x ULN Absolute granulocytes ³1.5 x 109 cells/L Platelets ³ 100,000/µL • Be able to read, understand, and willing to sign the Informed Consent Form (ICF) before entering the study
Exclusion criteria
Exclusion criteria: • Uncontrolled active infection. • Current mucositis ( >Grade 1). • Pregnancy or nursing mother. • Prior history of a cerebrovascular accident or hemorrhage. • Congestive heart failure as defined by New York Heart Association class III or IV. • Uncontrolled hypertension. • Active psychiatric/mental illness making informed consent or useful clinical follow-up unlikely. • Subjects who have previously been enrolled into this study and subsequently withdrew. • Subject receiving another investigational agent(s). • Any systemic immunosuppressive medication/therapy (e.g., other chemotherapy, steroids). • Any significant systemic illness, unstable or severe medical condition(s) that could put the subject at risk during the study, interfere with outcome measures or affect compliance with the protocol procedures such as intercurrent infection and/or autoimmune disease, i.e., any condition that compromises the immune system. • Known or suspected intolerance or hypersensitivity to the study materials (TK-112690 and/or excipients or closely related compounds). • Subjects, who have received, or plan to receive, radiation or chemotherapy within 4 weeks of screening. • Subjects that have a history of poor compliance in clinical research studies. • Subjects who have participated in any other investigative clinical trial in the past 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLTs: Any grade 3 or 4 dose-limiting systemic toxicity during the study graded according to the CTCAE (NCI Common Terminology Criteria for Adverse Events), v 4.0 that cannot clearly be attributed to a cause other than TK-112690Timepoint: 24 hrs,48 hrs of 1 to 4 week and week 5 and week 8 for Mucositiis Assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| MTD. Highest dose administered that is not associated with a DLT if three patients are treated or two or more DLTs if 6 patients are treated. PK. Confirmation that the PK of TK-112690 in patients is similar to the PK profile in healthy volunteers based on WinNonlin analysis of drug plasma concentrations. Biomarker. Demonstration theTimepoint: after PK,Biomarkers and surrogate Markers assessment | — |
Countries
India
Contacts
Public ContactDr Sagar Bhosale
CRBio ( A Division of RA CHEM PHARMA)
Outcome results
None listed