CPI-613 in Treating Patients With Advanced or Metastatic Bile Duct Cancer That Cannot Be Removed By Surgery

Completed · Phase 1/Phase 2

Conditions studied: Adult Primary Cholangiocellular Carcinoma, Advanced Adult Primary Liver Cancer, Cholangiocarcinoma of the Extrahepatic Bile Duct, Cholangiocarcinoma of the Gallbladder, Localized Unresectable Adult Primary Liver Cancer, Metastatic Extrahepatic Bile Duct Cancer, Recurrent Adult Primary Liver Cancer, Recurrent Extrahepatic Bile Duct Cancer, Unresectable Extrahepatic Bile Duct Cancer

In brief

This pilot clinical trial studies 6,8-bis(benzylthio)octanoic acid in treating patients with advanced or metastatic cholangiocarcinoma that cannot be removed by surgery. 6,8-Bis(benzylthio)octanoic acid may stop the growth of cholangiocarcinoma by blocking blood flow to the tumor

Key facts

Study ID: NCT01766219
Run by: Wake Forest University Health Sciences
People needed: 17
Starts: 2013-05-01
Expected to finish: 2018-05-18
Last updated by the study team: 2019-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histologically and cytologically proven cholangiocarcinoma of any type (including intrahepatic cholangiocarcinoma, extrahepatic primary cholangiocarcinoma, hilar cholangiocarcinomas, cholangiocarcinomas located in the gall bladder or hepatic capsule effraction, and carcinoma of the Ampulla of Vater, etc.) that is not amenable to surgery, radiation, or combined modality therapy with curative intent, and has failed or is not eligible for available chemotherapies such as gemcitabine with or without platinum
Local, locally-advanced, or metastatic disease documented as having shown progression on a scan (e.g., computed tomography [CT], magnetic resonance imaging [MRI])
Measurable tumor according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria with at least one unidimensionally measurable target lesion
No evidence of biliary duct obstruction, unless obstruction is controlled by local treatment or, in whom the biliary tree can be decompressed by endoscopic or percutaneous stenting with subsequent reduction in bilirubin to below 1.5 x upper level of normal (ULN)
No acute toxic effects from previous treatment superior to grade 1 at the start of the study
Eastern Cooperative Oncology Group (ECOG) performance status being 0-3
Expected survival > 3 months
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
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 =< 2.0 mg/dL or 177 µmol/L
International normalized ratio or INR must be =< 1.5
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

You may not qualify if…

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 CPI-613 treatment
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)
Pregnant women, or women of child-bearing potential not using reliable means of contraception (because the teratogenic potential of CPI-613 is unknown)
Lactating females
Fertile men unwilling to practice contraceptive methods during the study period
Life expectancy less than 3 months
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
Unwilling or unable to follow protocol requirements
Dyspnea with moderate exertion; patients with clinically significant pleural or pericardial effusions
Active 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; also patients with a history of myocardial infarction that is < 1 year prior to registration, or patients with previous congestive heart failure (< 1 year prior to registration) requiring pharmacologic support or with left ventricular ejection fraction < 50%)
A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome)
Evidence of active infection, or serious infection within the past month
Patients with known human immunodeficiency virus (HIV) infection
Patients who have received cancer immunotherapy of any type within the past 2 weeks prior to initiation of CPI-613 treatment
Requirement for immediate palliative treatment of any kind including surgery
Patients that have received a chemotherapy regimen with stem cell support in the previous 6 months
Prior illicit drug addiction
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of the patient

Where it is running

Comprehensive Cancer Center of Wake Forest University — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.