Clinical trial NCT02232152 (phase 1, status: active, not recruiting)
Conditions: mucinous adenocarcinoma of the colon, mucinous adenocarcinoma of the rectum, recurrent colon cancer, recurrent rectal cancer, signet ring adenocarcinoma of the colon, signet ring adenocarcinoma of the rectum, stage iiia colon cancer, stage iiia rectal cancer, stage iiib colon cancer, stage iiib rectal cancer, stage iiic colon cancer, stage iiic rectal cancer, stage iva colon cancer, stage iva rectal cancer, stage ivb colon cancer, stage ivb rectal cancer
ICD codes: C18.2, C18.4, C18.6, C18.7, C18.9, D12.2, D12.3, G47.13, J01.41, K11.22, K12.0, N96, F33.8, G03.2, C18.2, C18.4, C18.6, C18.7, C18.9, D12.2, D12.3, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C18.2, C18.4, C18.6, C18.7, C18.9, D12.2, D12.3, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C18.2, C18.4, C18.6, C18.7, C18.9, D12.2, D12.3, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C18.2, C18.4, C18.6, C18.7, C18.9, D12.2, D12.3, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C18.2, C18.4, C18.6, C18.7, C18.9, D12.2, D12.3, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: 6,8-bis(benzylthio)octanoic acid, fluorouracil
SMILES: OC(=O)CCCCC(CCSCC1=CC=CC=C1)SCC1=CC=CC=C1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically and cytologically confirmed metastatic colorectal adenocarcinoma
             (colon, rectal or colorectal cancer) that is not resectable

          -  Have failed or have not tolerated FOLFOX, FOLFIRI and, if KRAS wild type, then a EGFR
             inhibitor-based regimen

          -  Eastern Cooperative Oncology Group (ECOG) performance status being 0-2

          -  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

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

          -  At least 2 weeks must have elapsed from any prior surgery

          -  Granulocyte count >= 1500/mm^3

          -  White blood cell (WBC) >= 3500 cells/mm^3 or >= 3.5 bil/L

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

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

          -  Hemoglobin >= 9 g/dL or >= 90 g/L

          -  Aspartate aminotransferase (AST/serum glutamic oxaloacetic transaminase [SGOT]) =< 3 x
             upper normal limit (UNL), alanine aminotransferase (ALT/serum glutamate pyruvate
             transaminase [SGPT]) =< 3 x UNL (=< 5 x UNL if liver metastases present)

          -  Bilirubin =< 1.5 x UNL

          -  Serum creatinine =< 1.5 mg/dL or 13 umol/L

          -  International normalized ratio or INR must be =< 1.5 unless on therapeutic blood
             thinners

          -  No evidence of active infection and no serious infection within the past month

          -  Mentally competent, ability to understand and willingness to sign the informed consent
             form

          -  At least one measurable lesion as assessed by computed tomography (CT) scan using
             Response Evaluation Criteria in Solid Tumors (RECIST) criteria

        Exclusion Criteria:

          -  Therapy with CPI-613 prior to participating in this trial

          -  Known hypersensitivity to 5-FU injection, poor nutritional state, known dipyrimidine
             dehydrogenase deficiency, or taking sorivudine (such as Usevir, brovavir, etc.)

          -  History of hypersensitivity to active or inactive excipients of any component of
             treatment

          -  Previous radiotherapy for central nervous system metastases

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

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

          -  Any active uncontrolled bleeding, and any patients with a bleeding diathesis (e.g.,
             active peptic ulcer disease)

          -  History of abdominal fistula or gastrointestinal perforation =< 6 months prior to
             treatment with study drugs

          -  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

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

          -  Unwilling or unable to follow protocol requirements

          -  Symptomatic heart disease including but not limited to symptomatic congestive heart
             failure, symptomatic coronary artery disease, symptomatic angina pectoris, symptomatic
             myocardial infarction or symptomatic congestive heart failure

          -  Patients with a history of myocardial infarction that is < 3 months prior to
             registration

          -  Evidence of active infection, or serious infection within the past month

          -  Patients with known human immunodeficiency virus (HIV) infection, hepatitis B, or
             hepatitis C

          -  Patients who have received cancer immunotherapy of any type within the past 2 weeks
             prior to initiation of CPI-613 treatment; steroid use for management of refractory
             pain or for contrast induced allergy is allowed

          -  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 the patient