CPI-613 in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer

PRIMARY OBJECTIVES:

I. To evaluate the safety and anti-cancer activities in patients with relapsed or refractory
small cell lung cancer (SCLC) who have failed 1 or 2 lines of chemotherapy.

OUTLINE:

Patients receive CPI-613 intravenously (IV) over 2 hours on days 1 and 4 of weeks 1-3.
Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 2 months.

Inclusion Criteria:

- Histologically or cytologically proven SCLC that has relapsed or been refractory from
at least one line of chemotherapy

- Eastern Cooperative Oncology Group (ECOG) performance status of =< 3

- Expected survival > 1 month

- No acute toxicities from previous treatment higher than grade 1 at the start of
treatment with CPI-613

- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically
sterile) 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

- Men must practice effective contraceptive methods during the study, unless
documentation of infertility exists

- Platelet count >= 100,000 cells/mm^3 or >= 100 bil/L

- Absolute neutrophil count (ANC) >= 1500 cells/mm^3 or >= 1.5 bil/L

- Aspartate aminotransferase (AST/serum glutamic oxaloacetic transaminase [SGOT]) =< 3 x
upper normal limit (UNL)

- Bilirubin =< 1.5 x UNL

- Serum creatinine =< 1.5 mg/dL or 133 µmol/L

- Albumin > 2.0 g/dL or > 20 g/L

- Mentally competent, ability to understand and willingness to sign an Institutional
Review Board (IRB)-approved written informed consent form

- Have access via central line (e.g., portacath)-double lumen due to CPI-613
administration requirements

Exclusion Criteria:

- Patients receiving any other standard or investigational treatment for their cancer,
or any investigational agent for any non-cancer indication within the past 2 weeks
prior to initiation of CPI-613 treatment

- Serious medical illness that would potentially increase patients' risk for toxicity

- Any active uncontrolled bleeding or bleeding diathesis

- Pregnant women, women of child-bearing potential not using reliable means of
contraception, or lactating women

- Men unwilling to practice contraceptive methods during the study period

- Life expectancy less than 1 month

- Treatment with any anti-cancer therapy within the 2 weeks prior to treatment with
CPI-613

- Patients with untreated central nervous system (CNS) or epidural tumor

- Any condition or abnormality which may, in the opinion of the investigator, compromise
his or her safety

- Unwilling or unable to follow protocol requirements

- Active heart disease including myocardial infarction within previous 6 months,
symptomatic coronary artery disease, arrhythmias not controlled with medication, or
symptomatic congestive heart failure

- Evidence of active infection or serious infection (e.g., septic shock with multi-organ
dysfunction) within the past month

- Patients with known human immunodeficiency virus (HIV) infection

- Requirement for immediate palliative treatment of any kind including surgery