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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Advanced Cancer

Intervention / Treatment
-----------------
* Drug: SGX523 Capsules


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br> | Drug: SGX523 Capsules<br>* This is a dose escalation study<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose |  | Within first 28 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose Limiting Toxicities |  | Within first 21 days of therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Solid tumor, Advanced Cancer, MET Inhibitor, Receptor Tyrosine Kinase Inhibitor (RTKI)