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CPI-613 + Chemotherapy for Biliary Tract Cancer
Study Summary
This trial is testing a new drug, CPI-613, to see if it's safe and effective in treating biliary tract cancer when used with standard chemotherapy. There are two parts to the trial, and in the second part patients are randomly assigned to either receive CPI-613 or not. Researchers will compare how well patients do in each group.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2012 Phase 3 trial • 256 Patients • NCT01005680Trial Design
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Who is running the clinical trial?
Media Library
- I had major surgery less than 4 weeks ago.I am not pregnant or breastfeeding and have a negative pregnancy test if of childbearing age.I am 18 years old or older.I have a tumor that can be measured on scans and hasn't been treated with radiation or specific liver therapies.You are allergic to cisplatin, gemcitabine, or CPI-613.I can carry out all my usual activities without help.I do not have active heart disease or severe lung issues.I have been fever-free for more than 48 hours without antibiotics.I am willing to provide tissue samples from past surgeries or biopsies if they are available.I haven't had chemotherapy or targeted therapy for advanced bile duct cancer.I have had brain metastasis or an organ transplant but have been stable for 3 months.My cancer is in the bile ducts and cannot be surgically removed or cured with current treatments.My organs are functioning well, as confirmed by tests done within the last 2 weeks.I had treatments like radiation or surgery for my liver condition over 4 weeks ago and have recovered with minimal side effects.I agree to use two forms of contraception or practice abstinence during and for 6 months after the study.I can safely undergo CT or MRI scans with contrast.I had another cancer but was treated over a year ago and am now cancer-free.
- Group 1: Phase 2, Arm B (standard of care)
- Group 2: Phase 1 and Phase 2, Arm A (investigational)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many healthcare facilities are participating in this research venture?
"The trial is being conducted in select locations, such as Northwestern University - Lurie Comprehensive Cancer Center in Chicago; University Hospitals - Seidman Cancer Center in Cleveland; and the University of Michigan Rogel Cancer Center in Ann Arbor. An additional 10 sites are also associated with this project."
Is this research project currently open to new participants?
"The clinicaltrials.gov website has given confirmation that this research project is accepting participants. It was originally posted on June 23rd 2020 and the data was most recently revised on September 14th 2022."
Are there additional experiments that have utilized Cisplatin?
"Currently, there are 973 clinical trials underway analyzing the efficacy of Cisplatin with 336 in Phase 3. Shanghai is hosting the majority of these experiments; yet, 52709 other sites also have investigations running for this drug."
How many participants is this research project able to accommodate?
"This clinical trial necessitates 78 eligible volunteers. People living in the vicinity of Northwestern University - Lurie Comprehensive Cancer Center (Chicago, Illinois) or University Hospitals - Seidman Cancer Centre (Cleveland, Ohio) may be able to join this study."
What ailments is Cisplatin typically prescribed to address?
"Cisplatin has been shown to provide relief for patients suffering from advanced testicular cancer, neoplasm metastasis, and urinary bladder disorders."
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