CPI-613 in Treating Patients With Advanced or Metastatic Bile Duct Cancer That Cannot Be Removed By Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01766219|
Recruitment Status : Active, not recruiting
First Posted : January 11, 2013
Last Update Posted : September 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: 6,8-bis(benzylthio)octanoic acid||Phase 1 Phase 2|
I. To evaluate the safety and efficacy of CPI-613 (6,8-bis[benzylthio]octanoic acid) in patients with advanced unresectable cholangiocarcinoma who have failed available therapies.
Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid intravenously (IV) over 2 hours on days 1-5, 1 week prior to course 1.
Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment.
After completion of study treatment, patients are followed up bimonthly.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Open-Label Clinical Trial of CPI-613 in Patients With Advanced Bile Duct Cancers|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||October 2018|
Experimental: Treatment (6,8-bis[benzylthio]octanoic acid)
Pre-cycle: Patients receive 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5, 1 week prior to course 1.
Patients receive 6,8-bis(benzylthio)octanoic acid IVover 2 hours on days 1 and 4 of weeks 1-3. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive up to 4 more courses of treatment.
Drug: 6,8-bis(benzylthio)octanoic acid
- Overall survival [ Time Frame: From the first dose of 6,8-bis(benzylthio)octanoic acid to death, assessed up to 4 years ]Estimated using Kaplan-Meier techniques.
- Response rate defined as proportion of patients with complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD), using based on the RECIST version 1.1 [ Time Frame: From the start of the treatment until DP, assessed up to 4 year ]95% confidence interval will be included.
- Progression-free survival [ Time Frame: From the first dose of 6,8-bis(benzylthio)octanoic acid to disease progression (DP) or death due to any cause, assessed up to 4 years ]Estimated using Kaplan-Meier techniques.
- Adverse events, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 [ Time Frame: Up to 1 month after completion of study treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01766219
|United States, North Carolina|
|Comprehensive Cancer Center of Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Stefan Grant, MD||Wake Forest University Health Sciences|