Overview

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

Status:
Terminated
Trial end date:
2009-06-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
SGX Pharmaceuticals, Inc.
Criteria
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.