Dose-Escalation Phase 1 Study of G-202 (Mipsagargin) in Patients With Advanced Solid Tumors

Inclusion Criteria

• •Histologically-confirmed malignancy that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective
• •Disease that is measurable and/ or evaluable by RECIST criteria. Patients with prostate cancer require presence of disease on bone scan and/or CT scan and evidence of increasing PSA after standard hormonal therapy
• •ECOG Performance Status ≤ 2
• •Life expectancy estimated to be at least 3 months
• •Acceptable liver function:
• •* In the absence of disease involvement in the liver and if bilirubin ≤ 1.5 times institutional upper limit of normal (ULN), AST (SGOT), ALT (SGPT) and GGT may be ≤ 2 times ULN
• •* In the presence of disease involvement in the liver and if bilirubin ≤ 1.5 times institutional upper limit of normal (ULN), AST (SGOT), ALT (SGPT) and GGT may be ≤ 5 times ULN
• •* Alkaline phosphatase ≤ 2.5 times ULN Patients with bone metastases alkaline phosphatases ≤ 5 times ULN
• •Acceptable renal function:
• •* Serum creatinine ≤ 1.5 times ULN, OR
• •* Calculated creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula)
• •Acceptable hematologic status:
• •* Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 (1.5 ×109/L)
• •* Platelet count ≥ 100,000 platelet/mm3 (100 ×109/L)
• •* Hemoglobin ≥ 9 g/dL
• •Urinalysis with no evidence of proteinuria
• •Acceptable coagulation profile (PT or INR, PTT) \< 1.5 times ULN
• •At least 4 weeks since prior chemotherapy or surgery, with recovery to Grade 1 or baseline of significant toxicities felt related to prior drug(s)
• •Women of childbearing potential must have a negative serum pregnancy test at screening.
• •All patients (males and females) of child-bearing potential must agree to use an effective method of birth control
• •Ability to understand and willingness to sign a written informed consent document
• •Patients with prostate cancer must continue androgen deprivation therapy with LHRH agonists