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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum Tolerated Dose

Outcome Time Frame:

Within first 28 Days

Safety Issue:

Yes

Principal Investigator

Lee Rosen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Premier Onocology, California

Authority:

United States: Food and Drug Administration

Study ID:

SGX523-1A-002

NCT ID:

NCT00606879

Start Date:

January 2008

Completion Date:

June 2009

Related Keywords:

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

Name

Location

Sarah Cannon Research InstituteNashville, Tennessee  37203
Premier Onocology, CaliforniaSanta Monica, California  90404