Safety Study of SGX523, a Small Molecule Met Inhibitor, to Treat Solid Tumors - Full Text View

Purpose

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	Intervention	Phase
Advanced Cancer	Drug: SGX523 Capsules	Phase 1

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by SGX Pharmaceuticals, Inc.:

Primary Outcome Measures:

Maximum Tolerated Dose [ Time Frame: Within first 28 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

PK parameters: Cmin, Cmax, AUC∞, AUCtau, T1/2, Tmax, Vd, CLpo [ Time Frame: To 28 Days after patient withdrawal ] [ Designated as safety issue: No ]

Estimated Enrollment:	46
Study Start Date:	January 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Single arm	Drug: SGX523 Capsules This is a dose escalation study

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606879

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

No publications provided

Responsible Party:	Terry Rugg, MD, SGX Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00606879 History of Changes
Other Study ID Numbers:	SGX523-1A-002
Study First Received:	January 18, 2008
Last Updated:	July 22, 2008
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Keywords provided by SGX Pharmaceuticals, Inc.:

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

Additional relevant MeSH terms:

Neoplasms
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013