Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver (NCT04175912) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver
United States40 participantsStarted 2020-03-16
Plain-language summary
This phase II trial studies how well pevonedistat alone or in combination with chemotherapy (paclitaxel and carboplatin) works in treating patients with bile duct cancer of the liver. Pevonedistat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study may help the study doctors find out how well pevonedistat shrinks bile duct cancer of the liver when given alone and when in combination with paclitaxel and carboplatin.
Who can participate
Age range
18 Years
Sex
ALL
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:
* Patient must be \>= 18 years of age
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Patient must have a life expectancy \>= 12 weeks
* Patient must have histologically confirmed intrahepatic cholangiocarcinoma or biphasic hepatocellular carcinoma and cholangiocarcinoma that is metastatic or unresectable and who have progressed on or been intolerant of one prior line of systemic gemcitabine containing chemotherapy regimen.
* NOTE: Prior immunotherapy or targeted therapies are allowed and will not be considered a line of therapy unless administered with cytotoxic chemotherapy
* Patient must have measurable disease. For patients who have received localized therapy (embolization, chemoembolization, radiofrequency ablation or radiation) are eligible if measurable disease is not within the treatment field or the treated disease has clearly progressed since last localized therapy
* Leukocytes \>= 3,000/mcL (obtained within 14 days prior to randomization)
* Absolute neutrophil count \>= 1,500/mcL (obtained within 14 days prior to randomization)
* Platelets \>= 100,000/mcL (obtained within 14 days prior to randomization)
* Total bilirubin =\< institutional upper limit of normal (ULN) except in patients with Gilbert's syndrome. Patients with Gilbert's syndrome may enroll if direct bilirubin =\< 1.5 x ULN of the direct bilirubin (obtained within 14 days prior to randomization)
* Hemoglobin \>= 9 g/dL (obtained within 14…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 2 trial testing pevonedistat combined with chemotherapy for bile duct or liver cancer, what does that phase mean for how much we already know about its safety and effectiveness compared to standard treatments I could get right now?
2The trial is listed as 'active, not recruiting,' which means they're no longer enrolling new patients — does that affect my options at all, and are there similar trials still open that I should be looking into?
3The trial is measuring 'objective response,' meaning whether the tumor actually shrinks — based on what you know about this drug combination so far, is there any early data suggesting it might work better or worse for my specific type and stage compared to standard gemcitabine-based chemotherapy?
4Pevonedistat works differently from traditional chemotherapy by blocking a protein involved in cell growth — are there specific side effects or organ-related risks I should be aware of, especially given that bile duct and liver cancers can already affect liver function?
5Before considering a trial like this one, would it make more sense for me to try an approved first-line treatment first, or is there a reason this combination might be worth pursuing earlier in my treatment plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response
Timeframe: Every 3 months for the first year and every 6 months for years 2-3