Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
SGX Pharmaceuticals, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject has the ability to understand, able, willing to comply with study procedures and follow up visits, and has provided written consent.
Pathologic evidence of solid tumor.
Failed standard therapy and deemed by the Investigator to be suitable for participation into the trial.
Laboratory values (obtained within 10 days prior to enrollment): ANC: \>= 1.5 × 109/L; Platelets: \>= 100 × 109/L; Hemoglobin: \>= 10.0 g/dL (without transfusions); Bilirubin: within normal range; AST, ALT, and alkaline phosphatase: \<= 2.5 x ULN without tumor liver involvement; Serum creatinine: within normal limits; Calculated creatinine clearance: \>= 60 mL/min/1.73 m2 for patients with creatinine \> Institutional Normal Values; PT/PTT/INR: within normal limits.
Have IHC evidence of phospho-MET expression on tumor material no more than 12 months old. This is a requirement only for entry into the MTD dose expansion phase.
Have no residual toxic effects of previous therapy, and undergo a washout period of at least 5 half-lives from the time of administration of the previous therapy.
You may not be if
Pregnant, lactating, or may become pregnant.
Cardiac disease requiring medical therapy.
Have had a major surgery within 4 weeks prior to Day 1 of the study
Have an active, uncontrolled bacterial, viral, or fungal infection that requires ongoing systemic therapy.
Have a known active infection with HIV, hepatitis B or C.
Have psychiatric or seizure disorders that would require therapy or interfere with study participation.
Have other severe concurrent nonmalignant disease that could compromise protocol objectives, including malabsorptive conditions.
Patients receiving prohibited medications as listed in Appendix E, including drugs categorized as strong inhibitors of CYP3A4 and A5 and drugs known to have a high potential risk of liver toxicity.
Have known allergy to SGX523 formulation or its excipients (croscarmellose sodium, lactose monohydrate and magnesium stereate).
