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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00606879
Recruitment Status : Terminated
First Posted : February 5, 2008
Last Update Posted : July 24, 2008
Sponsor:
Information provided by:
SGX Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE January 18, 2008
First Posted Date  ICMJE February 5, 2008
Last Update Posted Date July 24, 2008
Study Start Date  ICMJE January 2008
Estimated Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2008)
Maximum Tolerated Dose [ Time Frame: Within first 28 Days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2008)
PK parameters: Cmin, Cmax, AUC∞, AUCtau, T1/2, Tmax, Vd, CLpo [ Time Frame: To 28 Days after patient withdrawal ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Cancer
Intervention  ICMJE Drug: SGX523 Capsules
This is a dose escalation study
Study Arms  ICMJE 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
 (submitted: January 22, 2008)
46
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00606879
Other Study ID Numbers  ICMJE SGX523-1A-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
PRS Account 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