CT791: This phase I trial is evaluating an oral drug (DpC) for the treatment of advanced cancers (excluding blood cancer)A Phase 1 Dose-finding and Pharmacokinetic Study of DpC, Administered Orally to Patients With Advanced Solid Tumors

Inclusion

• Signed informed consent prior to initiation of any study-specific procedures;
• Histologically or cytologically confirmed diagnosis of an advanced or metastatic solid tumor for which standard therapy either does not exist or has proven ineffective, intolerable, or unacceptable for the patient;
• At least one measurable lesion as defined by RECIST v1.1, except for patients with castrate resistant prostate cancer, who may be enrolled with objective evidence of disease per PCWG2 criteria, and patients with ovarian cancer who may be enrolled without measurable disease but who are evaluable by CA125 per GCIC criteria;
• life expectancy at least 3 months;
• ECOG performance status 0-1;
• Adequate bone marrow reserve, cardiac, renal and liver function, defined by
• absolute neutrophil count at least 1.5 x 10(9)/L;
• platelet count at least 100 x 10(9)/L;
• hemoglobin at least 9 g/dL;
• ferritin at least 50 ug/L;
• ECHO shows ejection fraction at least 50% and no evidence of cardiac dysfunction;
• creatinine clearance >50 mL/min (Cockcroft & Gault formula);
• AST/ALT no more than 3 x ULN (5 x ULN if liver or bone involvement);
• serum albumin at least 28 g/L;
• INR no more than 1.5 x ULN;
• At least 3 weeks since chemotherapy, immunotherapy, hormone therapy, r other anticancer therapy or surgical intervention or at least 3 half-lie for monoclonal antibodies;
• Patients with castrate-resistant prostate cancer must maintain ongoing androgen deprivation therapy to provide serum testosterone <50 mg/dL;
• Patients receiving bisphosphonate or denosumab therapy must be on stable doses for at least 4 weeks before initiating study treatment.