Safety Study of SGX523, a Small Molecule Met Inhibitor, to Treat Solid Tumors

SGX Pharmaceuticals

Status and phase

Terminated

Phase 1

Conditions

Advanced Cancer

Treatments

Drug: SGX523 Capsules

Study type

Interventional

Funder types

Industry

Identifiers

NCT00607399

SGX523-1A-001

Details and patient eligibility

About

SGX523 is a drug which acts by blocking the function of an enzyme called MET. MET activity may be important in growth and survival of some types of cancer. This Phase I trial is studying the safety, side effects, and best dose of SGX523 when given to patients with advanced cancer, and how well it inhibits MET activity in tumors.

Enrollment

46 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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).
Patients receiving anti-coagulant therapy.