A Study of Pevonedistat in People With Blood Cancers or Solid Tumors With Kidney or Liver Problems (NCT03814005) | Clinical Trial Compass
CompletedPhase 1
A Study of Pevonedistat in People With Blood Cancers or Solid Tumors With Kidney or Liver Problems
United States, Spain17 participantsStarted 2019-07-10
Plain-language summary
Pevonedistat is a medicine to treat people with blood cancers or solid tumors.
The main aim of the study is to learn about the levels of pevonedistat in the blood of participants with blood cancers or solid tumors, who also have severe kidney problems or mild to moderate liver problems. The information from this study will be used to work out the best dose of pevonedistat to give people with these conditions in future studies. At the first visit, the study doctor will check who can take part in the study.
This study is in 2 parts: A and B.
Part A Participants will be placed into 1 of 4 treatment groups depending on how severe their kidney and liver problems are. All participants will receive 1 dose of pevonedistat as a slow injection in their vein (infusion). Then, the study doctors will check the levels of pevonedistat in the blood of the participants for 3 days after the infusion. They will also check if the participants have any side effects from pevonedistat.
Participants will be asked to continue to Part B. Those who don't want to continue will visit the clinic 30 days later for a final check-up.
Part B Participants who agree to participate into Part B will receive an infusion of pevonedistat on specific days during a 21-day or 28-day cycle. The cycle time will depend on what type of cancer the participants have. Participants will also be treated with standard of care medicines for their kidney and liver problems during this time. In the first cycle, the study doctors will also check the levels of pevonedistat in the blood and urine of participants for 3 days after the infusion. Participants will continue with cycles of treatment together with standard of care medicines until their condition gets worse or they have too many side effects from the treatment.
When treatment has finished, participants will visit the clinic 10 days later for a final check-up.
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
. Has expected survival of at least 3 months from the date of enrollment in the study.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
. Has recovered (that is, Grade \<=1 toxicity) from the reversible effects of prior anticancer therapy.
. Prothrombin time (PT) and activated partial thromboplastin time (aPTT) \<=1.5 \* upper limit of the normal range (ULN) at screening or within 7 days before the first dose of study drug.
. Suitable venous access for the study-required blood sampling (that is, PK sampling).
. Previously untreated hematologic malignancies not suitable for induction therapy.
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
Part A, AUC∞: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for Pevonedistat Following a Single Dose
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
2
Part A, AUClast: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for Pevonedistat Following a Single Dose
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
3
Part A, Cmax: Maximum Observed Plasma Concentration for Pevonedistat Following a Single Dose
Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
. Morphologically confirmed diagnosis of MDS or nonproliferative CMML (that is, with white blood cell \[WBC\] \<13,000 /mcL) at the study entry, based on one of the following:
. With MDS or CMML and must also have one of the following Prognostic Risk Categories, based on the Revised International Prognostic Scoring System (IPSS-R):
Exclusion criteria
. With end-stage renal disease requiring hemodialysis.
. Has Gilbert syndrome.
. Has active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, or septicemia. Prophylactic treatment with antibiotics is allowed.
. Has life-threatening illness unrelated to cancer.
. Known human immunodeficiency virus (HIV) seropositive.
. Treatment with strong cytochrome P450 (CYP)3A inducers within 14 days before the first dose of pevonedistat.
. Has left ventricular ejection fraction (LVEF) \<50% within 6 months prior to study enrollment. If a result within this time frame is unavailable, LVEF must be determined by echocardiography or multigated acquisition scan at screening.
. Has severe uncontrolled ventricular arrhythmias or torsade de pointes; electrocardiographic evidence of acute ischemia or active conduction system abnormalities; or clinically significant arrhythmia (as an example, well-controlled atrial fibrillation would not be an exclusion whereas uncontrolled atrial fibrillation would be an exclusion).