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

This study has been terminated.

Sponsor:

Information provided by:

SGX Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT00606879

First received: January 18, 2008

Last updated: July 22, 2008

Last verified: July 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

January 18, 2008

Last Updated Date

July 22, 2008

Start Date ^ICMJE

January 2008

Estimated Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00606879 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Advanced Cancer

Intervention ^ICMJE

Drug: SGX523 Capsules

This is a dose escalation study

Study Arm (s)

Experimental: Single arm

Intervention: Drug: SGX523 Capsules

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2009

Estimated Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00606879

Other Study ID Numbers ^ICMJE

SGX523-1A-002

Has Data Monitoring Committee

Responsible Party

Terry Rugg, MD, SGX Pharmaceuticals, Inc.

Study Sponsor ^ICMJE

SGX Pharmaceuticals, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

SGX Pharmaceuticals, Inc.

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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