Status:
TERMINATED
Safety Study of SGX523, a Small Molecule Met Inhibitor, to Treat Solid Tumors
Lead Sponsor:
SGX Pharmaceuticals, Inc.
Conditions:
Advanced Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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, s...
Eligibility Criteria
Inclusion
- 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
- 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 steareate)
- Patients receiving anti-coagulant therapy
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00606879
Start Date
January 1 2008
End Date
June 1 2009
Last Update
July 24 2008
Active Locations (2)
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1
Premier Onocology, California
Santa Monica, California, United States, 90404
2
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203