Advanced Cancer
Conditions
Keywords
Solid tumor, Advanced Cancer, MET inhibitor, Receptor Tyrosine Kinase Inhibitor (RTKI)
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.
Interventions
DRUGSGX523 Capsules
This is a dose escalation study
Sponsors
SGX Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 steareate) * Patients receiving anti-coagulant therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerated Dose | Within first 28 Days |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters: Cmin, Cmax, AUC∞, AUCtau, T1/2, Tmax, Vd, CLpo | To 28 Days after patient withdrawal |
Countries
United States
Outcome results
None listed