A Phase I, Multi-Center, Open Label, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Orally Administered SGX523, a Small Molecule Anti-Cancer Agent, Ona Twice Daily, Interrupted Schedule in Patients With Advanced Cancer
- 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.
- 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
- 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).
- Patients receiving anti-coagulant therapy.