Pralsetinib DDI Study in Patients With Advanced or Metastatic Solid Tumors (NCT07704658) | Clinical Trial Compass
RecruitingPhase 4
Pralsetinib DDI Study in Patients With Advanced or Metastatic Solid Tumors
Spain12 participantsStarted 2026-03-04
Plain-language summary
An open-label drug-drug interaction study to evaluate the effects of pralsetinib (Gavreto) on the pharmacokinetics of a CYP450 probe substrate cocktail and, in female participants, a hormonal probe substrate, in participants with rearranged during transfection (RET) fusion- or mutation-positive solid tumors
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
. Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L.
. Platelet count ≥ 75 × 10⁹/L.
. Hemoglobin ≥ 9 g/dL.
. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN), or ≤ 5 × ULN in patients with known liver metastases.
. Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN in patients with Gilbert syndrome).
. Creatinine clearance ≥ 40 mL/min using the Cockcroft-Gault equation.
. Serum phosphorus ≤ 5.5 mg/dL.
. International normalized ratio (INR), prothrombin time (PT), and activated partial thromboplastin time (aPTT) within normal laboratory limits.
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
Area Under the Plasma Concentration-Time Curve from zero to infinity (AUC0-inf)
Timeframe: Up to 48 hours post-dose or as appropriate for each probe substrate
2
Area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast)
Timeframe: Up to 48 hours after each probe drug administration
3
Maximum Peak Plasma Concentration (Cmax)
Timeframe: Up to 48 hours after each probe drug administration
. New York Heart Association (NYHA) Class III or IV congestive heart failure.
. Myocardial infarction or unstable angina within the previous 6 months, clinically significant uncontrolled arrhythmias, including bradyarrhythmias that may cause QT prolongation (e.g., second- or third-degree heart block).
. Uncontrolled hypertension (i.e., mean systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg on 3 repeated measurements) or clinically significant hypotension (i.e., systolic blood pressure \<90 mmHg and/or diastolic blood pressure \<50 mmHg) or severe episodes of orthostatic hypotension.
. History of prolonged QT syndrome or torsades de pointes, or familial history of long QT syndrome.
. QTcF ≥470 ms on at least 2 ECGs performed \>30 minutes apart.