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

• ClinicalTrials.gov Identifier: NCT00606879
• Recruitment Status: Terminated
• First Posted: February 5, 2008
• Last Update Posted: July 24, 2008
• Sponsor: SGX Pharmaceuticals, Inc.
• Information provided by: SGX Pharmaceuticals, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Advanced Cancer	Drug: SGX523 Capsules	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 46 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I, Multi-Center, Open Label, Dose Escalation, Safety, PK and PkD Study of Orally Administered SGX523, a Small Molecule Anti-Cancer Agent, on a Twice Daily, Uninterrupted Schedule in Patients With Advanced Cancer
• Study Start Date: January 2008
• Estimated Primary Completion Date: January 2009
• Estimated Study Completion Date: June 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Single arm	Drug: SGX523 Capsules; This is a dose escalation study

Outcome Measures

Primary Outcome Measures :

1. Maximum Tolerated Dose [ Time Frame: Within first 28 Days ]

Secondary Outcome Measures :

1. PK parameters: Cmin, Cmax, AUC∞, AUCtau, T1/2, Tmax, Vd, CLpo [ Time Frame: To 28 Days after patient withdrawal ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

Premier Onocology, California

Santa Monica, California, United States, 90404

United States, Tennessee

Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203

Sponsors and Collaborators

SGX Pharmaceuticals, Inc.

Investigators

• Principal Investigator: Lee Rosen, MD; Premier Onocology, California
• Principal Investigator: Howard Burris, MD; Sarch Cannon Research Institute

More Information

• Responsible Party: Terry Rugg, MD, SGX Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT00606879
• Other Study ID Numbers: SGX523-1A-002
• First Posted: February 5, 2008
• Last Update Posted: July 24, 2008
• Last Verified: July 2008

Keywords provided by SGX Pharmaceuticals, Inc.:

Solid tumor; Advanced Cancer; MET inhibitor; Receptor Tyrosine Kinase Inhibitor (RTKI)

Additional relevant MeSH terms:

Neoplasms