Phase 2 Safety, Tolerability and Efficacy Study of CPI-613 in Cancer Patients

Inclusion Criteria:

* Patients must have advanced and/or metastatic, histologically or cytologically documented solid tumors, for whom there is no available therapy shown to provide clinical benefit or for those who have refused further standard therapy
* Eastern Cooperative Oncology Group (ECOG) performance status being 0-2
* Expected survival \>3 months
* 18 years of age or older of both genders
* Women of child-bearing potential must use accepted contraceptive methods (abstinence, intrauterine device \[IUD\], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation.
* Fertile men must practice effective contraceptive methods during the study, unless documentation of infertility exists
* Mentally competent, with an ability to understand and willingness to sign the informed consent form
* No radiotherapy, treatment with cytotoxic agents (except CPI-613), or treatment with biologic agents within 3 weeks prior to treatment with CPI-613. At least 2 weeks must have elapsed from any prior surgery or hormonal therapy. Patients must have fully recovered from the acute toxicities of any prior treatment with any anti-cancer drugs, radiotherapy or other anti-cancer modalities (returned to baseline status as noted before most recent treatment). Patients with persisting, stable chronic toxicities from prior treatment ≤Grade 1 are eligible, but must be documented as such.
* Laboratory values ≤2 weeks must be:
* Adequate hematologic (white blood cell \[WBC\] ≥3500 cells/mm3 or ≥3.5 bil/L; platelet count ≥150,000 cells/mm3 or ≥150 bil/L; absolute neutrophil count \[ANC\] ≥1500 cells/mm3 or ≥1.5 bil/L; and hemoglobin (Hgb) ≥9 g/dL or ≥90 g/L).
* Adequate hepatic function (aspartate aminotransferase \[AST/SGOT\] ≤3x upper normal limit \[UNL\], alanine aminotransferase \[ALT/SGPT\] ≤3x UNL (≤5x UNL if liver metastases present), bilirubin ≤1.5x UNL).
* Adequate renal function (serum creatinine ≤2.0 mg/dL or 177 μmol/L, and blood urea nitrogen \[BUN\] ≤25 mg/dL).
* Adequate coagulation ("International Normalized Ratio or INR must be ≤1.5")

Exclusion Criteria:

* Serious medical illness
* Any active uncontrolled bleeding or patients with a bleeding diathesis
* Patients with active central nervous system (CNS) or epidural tumor
* Pregnant women, or women of child-bearing potential not using reliable means of contraception
* Lactating females
* Fertile men unwilling to practice contraceptive methods during the study period
* Life expectancy less than 3 months
* Unwilling or unable to follow protocol requirements
* Dyspnea with minimal to moderate exertion, or patients with pleural, pericardial, or peritoneal effusions
* Active heart disease including but not limited to symptomatic congestive heart failure, symptomatic coronary artery disease, symptomatic angina pectoris, symptomatic myocardial infarction, arrhythmias requiring medication, or symptomatic congestive heart failure.
* A marked baseline prolongation of QT/QTc interval; a history of additional risk factors for torsade de pointes.
* Requirement for immediate palliative treatment of any kind including surgery
* Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
* Albumin \<2.5 g/dL or \<25 g/L
* Evidence of active infection, or serious infection, with the past month
* Patients with known HIV infection.
* Patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication within the past 3 weeks prior to initiation of CPI-613 treatment.
* Patients who have received immunotherapy of any type within the past 4 weeks prior to initiation of CPI-613 treatment
* Patients that have received a chemotherapy regimen with stem cell support in the previous 6 months
* Troponin I above institution limit of normal