Ricolinostat, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Unresectable or … (NCT02856568) | Clinical Trial Compass
WithdrawnPhase 1
Ricolinostat, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Unresectable or Metastatic Cholangiocarcinoma
Stopped: Site dropped study
United States0Started 2017-05-01
Plain-language summary
This phase Ib trial studies the side effects and best dose of ricolinostat when given together with gemcitabine hydrochloride and cisplatin in treating patients with cholangiocarcinoma that cannot be removed by surgery or has spread to other places in the body. Ricolinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, 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. Giving ricolinostat together with gemcitabine hydrochloride and cisplatin may work better in treating patients with cholangiocarcinoma that cannot be removed by surgery or has spread to other places.
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:
* Histological or cytologic confirmation of unresectable or metastatic cholangiocarcinoma (intrahepatic, hilar, extrahepatic bile duct)
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
* Absolute neutrophil count (ANC) \>= 1200/mm\^3
* Platelet count \>= 100,000/mm\^3
* Total bilirubin \< 1.5 x upper limit of normal (ULN), If patient has known Gilbert's syndrome, direct bilirubin \< 2.0 x ULN
* Aspartate transaminase (AST) =\< 5 x ULN
* Alkaline phosphatase =\< 5 x ULN
* Creatinine =\< 1.5 x ULN
* Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only
* Ability to complete a patient medication diary by themselves or with assistance
* Provide informed written consent
* Willingness to return to enrolling institution for follow-up (during the active monitoring phase of the study)
* Willingness to provide tissue and blood samples for correlative research purposes
* Life expectancy \>= 3 months
* Prior embolization, chemoembolization, or radiofrequency ablation permitted if \>= 4 weeks from registration and evidence of new tumor growth is present
Exclusion Criteria:
* Any of the following
* Pregnant women
* Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception
* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriat…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
MTD of ricolinostat or a dose up to 240 mg/day whichever is lower, of ACY-1215
Timeframe: Cycle 1, Day 1 pre-dose
2
MTD of ricolinostat or a dose up to 240 mg/day whichever is lower, of ACY-1215
Timeframe: Cycle 1, Day 8 pre-dose
3
MTD of ricolinostat or a dose up to 240 mg/day whichever is lower, of ACY-1215
Timeframe: 0.5 hr after ACY-1215 dosing
4
MTD of ricolinostat or a dose up to 240 mg/day whichever is lower, of ACY-1215
Timeframe: 24 hr after Cycle 1, Day 1 only
5
MTD of ricolinostat or a dose up to 240 mg/day whichever is lower, of ACY-1215
Timeframe: Prior to Cycle 1, Day 2 ACY-1215 dosing
6
MTD of ricolinostat or a dose up to 240 mg/day whichever is lower, of ACY-1215
Timeframe: 1 hr after ACY-1215 dosing
7
MTD of ricolinostat or a dose up to 240 mg/day whichever is lower, of ACY-1215