Safety Study of SGX523, a Small Molecule Met Inhibitor, to Treat Solid Tumors
Phase 1
Terminated
- Conditions
- Advanced Cancer
- Interventions
- Drug: SGX523 Capsules
- Registration Number
- NCT00607399
- Lead Sponsor
- SGX Pharmaceuticals, Inc.
- 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, side effects, and best dose of SGX523 when given to patients with advanced cancer, and how well it inhibits MET activity in tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 46
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single arm SGX523 Capsules -
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose Within first 28 Days
- Secondary Outcome Measures
Name Time Method Dose Limiting Toxicities Within first 21 days of therapy
Trial Locations
- Locations (2)
Scottsdale Healthcare
🇺🇸Scottsdale, Arizona, United States
Premiere Oncology, Arizona
🇺🇸Scottsdale, Arizona, United States