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

Advanced Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00606879
• Other study ID #: SGX523-1A-002
• Status: Terminated
• Phase: Phase 1
• First received: January 18, 2008
• Last updated: July 22, 2008
• Start date: January 2008
• Est. completion date: June 2009

Study information

• Verified date: July 2008
• Source: SGX Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: June 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

Intervention

Drug:
• SGX523 Capsules
This is a dose escalation study

Locations

Country	Name	City	State
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Premier Onocology, California	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
SGX Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose		Within first 28 Days	Yes
Secondary	PK parameters: Cmin, Cmax, AUC8, AUCtau, T1/2, Tmax, Vd, CLpo		To 28 Days after patient withdrawal	No