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

NCT ID: NCT00606879

Last Updated: 2008-07-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-06-30

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.

Conditions

Advanced Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm

Group Type: EXPERIMENTAL

SGX523 Capsules

Intervention Type: DRUG

This is a dose escalation study

Interventions

SGX523 Capsules

This is a dose escalation study

Intervention Type: DRUG

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 steareate)
• Patients receiving anti-coagulant therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SGX Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

SGX Pharmaceuticals, Inc.

Principal Investigators

Lee Rosen, MD

Role: PRINCIPAL_INVESTIGATOR

Premier Onocology, California

Howard Burris, MD

Role: PRINCIPAL_INVESTIGATOR

Sarch Cannon Research Institute

Locations

Premier Onocology, California

Santa Monica, California, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

SGX523-1A-002

Identifier Type: -

Identifier Source: org_study_id