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Alkylating Agent

CPI-613 + Chemotherapy for Biliary Tract Cancer

Phase 1 & 2
Waitlist Available
Led By Vaibhav Sahai, MBBS, MS
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be ≥ 18 years of age.
Patients must have radiographically measurable disease (as per RECISTv1.1) in at least one site not previously treated with radiation or liver directed therapy (including bland, chemo- or radio-embolization, or ablation) either within the liver or in a metastatic site.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years after enrollment
Awards & highlights

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.

Who is the study for?
This trial is for adults with advanced biliary tract cancer that can't be removed by surgery. They should have measurable disease, no prior systemic treatment for this cancer, and must not have had major surgery or uncontrolled infections recently. Participants need to agree to use two forms of contraception and cannot be pregnant or breastfeeding.Check my eligibility
What is being tested?
Researchers are testing the safety and effectiveness of CPI-613 (devimistat) combined with standard chemotherapy (gemcitabine plus cisplatin) versus just the chemotherapy alone. The study has two parts: finding the best dose of CPI-613 in phase 1, then comparing health outcomes between the two treatments in phase 2.See study design
What are the potential side effects?
Possible side effects include reactions related to CPI-613, gemcitabine, or cisplatin such as nausea, fatigue, blood count changes, kidney issues from cisplatin; allergic reactions might occur due to any component they're sensitive to.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have a tumor that can be measured on scans and hasn't been treated with radiation or specific liver therapies.
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I can carry out all my usual activities without help.
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I am willing to provide tissue samples from past surgeries or biopsies if they are available.
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I haven't had chemotherapy or targeted therapy for advanced bile duct cancer.
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My cancer is in the bile ducts and cannot be surgically removed or cured with current treatments.
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My organs are functioning well, as confirmed by tests done within the last 2 weeks.
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I had treatments like radiation or surgery for my liver condition over 4 weeks ago and have recovered with minimal side effects.
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I agree to use two forms of contraception or practice abstinence during and for 6 months after the study.
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I can safely undergo CT or MRI scans with contrast.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years after enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years after enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1: Incidence of dose-limiting toxicity
Phase 2: Overall Response Rate (ORR)
Secondary outcome measures
Incidence of Toxicities
Median Overall Survival (OS)
Median Progression Free Survival (PFS)

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680
51%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Ischaemic stroke
1%
Cerebral infarction
1%
Dyspnoea
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Phase 1 and Phase 2, Arm A (investigational)Experimental Treatment3 Interventions
On Day 1 and Day 8 of each 3-week cycle, patients will receive CPI-613 + gemcitabine and cisplatin. Patients may continue gemcitabine, cisplatin and CPI-613 for up to 2 years in absence of disease progression or unacceptable toxicity.
Group II: Phase 2, Arm B (standard of care)Active Control2 Interventions
On Day 1 and Day 8 of each 3-week cycle, patients will receive gemcitabine and cisplatin. Patients may continue gemcitabine and cisplatin for up to 2 years in absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Gemcitabine
2017
Completed Phase 3
~2070

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor
292 Previous Clinical Trials
24,042 Total Patients Enrolled
Vaibhav Sahai, MBBS, MSPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center
4 Previous Clinical Trials
144 Total Patients Enrolled

Media Library

Cisplatin (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04203160 — Phase 1 & 2
Biliary Tract Cancer Research Study Groups: Phase 2, Arm B (standard of care), Phase 1 and Phase 2, Arm A (investigational)
Biliary Tract Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT04203160 — Phase 1 & 2
Cisplatin (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04203160 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~10 spots leftby Nov 2024