Safety Study of SGX523, a Small Molecule Met Inhibitor, to Treat Solid Tumors
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Cancer | Drug: SGX523 Capsules | Phase 1 |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: Single arm |
Drug: SGX523 Capsules
This is a dose escalation study |
- Maximum Tolerated Dose [ Time Frame: Within first 28 Days ]
- PK parameters: Cmin, Cmax, AUC∞, AUCtau, T1/2, Tmax, Vd, CLpo [ Time Frame: To 28 Days after patient withdrawal ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606879
United States, California | |
Premier Onocology, California | |
Santa Monica, California, United States, 90404 | |
United States, Tennessee | |
Sarah Cannon Research Institute | |
Nashville, Tennessee, United States, 37203 |
Principal Investigator: | Lee Rosen, MD | Premier Onocology, California | |
Principal Investigator: | Howard Burris, MD | Sarch Cannon Research Institute |
Responsible Party: | Terry Rugg, MD, SGX Pharmaceuticals, Inc. |
ClinicalTrials.gov Identifier: | NCT00606879 |
Other Study ID Numbers: |
SGX523-1A-002 |
First Posted: | February 5, 2008 Key Record Dates |
Last Update Posted: | July 24, 2008 |
Last Verified: | July 2008 |
Solid tumor Advanced Cancer MET inhibitor Receptor Tyrosine Kinase Inhibitor (RTKI) |
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