CPI-613 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer (NCT01839981) | Clinical Trial Compass
CompletedPhase 1
CPI-613 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
United States10 participantsStarted 2013-07
Plain-language summary
This pilot clinical trial studies 6,8-bis(benzylthio)octanoic acid in treating patients with locally advanced or metastatic pancreatic cancer. Drugs used in chemotherapy, such as 6,8-bis(benzylthio)octanoic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically and cytologically proven locally advanced or metastatic pancreatic adenocarcinoma that is not amenable to surgery, radiation, or combined modality therapy with curative intent, and has failed or is not eligible for available chemotherapies
* 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 of 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 one week prior to treatment initiation
* Fertile men must practice effective contraceptive methods during the study, unless doc…
What they're measuring
1
Overall Survival
Timeframe: From the first dose of 6,8-bis(benzylthio)octanoic acid to death, assessed up to 3 years