BridgeMD
An open-label, pharmacokinetic, safety, and efficacy study (Part I, single cycle) and double-blind, efficacy, non inferiority, and safety study of IV NEPA (Part II, repeated cycles) versus active comparator in the prevention of CINV in paediatric cancer patients undergoing single-day HEC and multi-day HEC.
EU CTIS ID: 2024-514321-39-00
What this study is testing
Part I: Cohort 1: To confirm by netupitant PK assessment that a single dose of 3.13 mg/kg IV fosnetupitant (for patients aged ≥3 months up to 24-120 h) phase of emesis in paediatric cancer patients aged between ≥6 months and <18 years receiving multi-day HEC.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Part I: Cohort 1: Patient < 6 months weighing at least 4 kg or patient ≥ 6 months weighing at least 6 kg. Cohort 2: Patient weighing at least 4 kg.
- Part I and Part II: Patient with non-clinically significant abnormal laboratory values or with clinically relevant abnormal laboratory values may be enrolled if in the Investigator’s opinion the patient’s safety is not expected to be jeopardized.
- Part I: Cohort 1: Patient scheduled and eligible to receive at least 1 cycle of single-day HEC. Cohort 2: Patient scheduled and eligible to receive at least 1 cycle of multi-day HEC.
- Part II: Patient weight at least 6 kg.
- Part II: Patient scheduled and eligible to receive repeated cycles of multi-day HEC.
- Part I and Part II: Patient with a predicted life expectancy ≥3 months according to Investigator’s opinion.
You likely can't join if
- Part I and Part II: Patient has received or is scheduled to receive total body irradiation; total nodal irradiation; upper abdomen radiotherapy; half or upper body irradiation; or radiotherapy of the cranium, craniospinal regions, head and neck, lower thorax region, or the pelvis within 1 week prior to study entry (Day 1) or within 120 h after last study drug administration.
- Part I and Part II: Any illness or condition that, in the opinion of the Investigator, may pose unwarranted risks in administering the investigational product to the patient.
- Part I and Part II: Uncontrolled medical condition (e.g., uncontrolled insulin-dependent diabetes mellitus).
- Part I and Part II: Patient experiencing ongoing vomiting from any organic aetiology (including patients with history of gastric outlet obstruction or intestinal obstruction due to adhesions or volvulus), or patient with hydrocephalus.
- Part I and Part II: Use of any drugs or substances known to interfere with CYP3A4 or CYP2D6 enzymes within 1 week prior to Day 1
- Part I and Part II: Marked baseline prolongation of QTc interval (QTcF>460 millisecond [msec]). At the discretion of the investigator, criterion may be based on automatic interpretation of results.
See the full eligibility criteria
Who can join
- Part I: Cohort 1: Patient < 6 months weighing at least 4 kg or patient ≥ 6 months weighing at least 6 kg. Cohort 2: Patient weighing at least 4 kg.
- Part I and Part II: Patient with non-clinically significant abnormal laboratory values or with clinically relevant abnormal laboratory values may be enrolled if in the Investigator’s opinion the patient’s safety is not expected to be jeopardized.
- Part I: Cohort 1: Patient scheduled and eligible to receive at least 1 cycle of single-day HEC. Cohort 2: Patient scheduled and eligible to receive at least 1 cycle of multi-day HEC.
- Part II: Patient weight at least 6 kg.
- Part II: Patient scheduled and eligible to receive repeated cycles of multi-day HEC.
- Part I and Part II: Patient with a predicted life expectancy ≥3 months according to Investigator’s opinion.
- Part I and Part II: For patients aged ≥10 years: Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤2.
- Part I and Part II: For patient with known hepatic impairment: the patient may be enrolled provided the serum ALT and AST are ≤2.5 ULN, the total bilirubin is ≤1.5 ULN, and in the Investigator’s opinion the impairment is not expected to jeopardize the patient’s safety during the study.
- Part I and Part II: For patient with known renal impairment: the patient may be enrolled provided the estimated glomerular filtration rate (eGFR) is ≥70 mL/min/1.73m2 (≥50 mL/min/1.73m2 for children <3 months old) (the eGFR should be calculated using the modified Schwartz equation) and in the Investigator’s opinion the impairment is not expected to jeopardize the patient’s safety during the study.
- Part I and Part II: For patient with known history or predisposition to cardiac abnormalities: as per the Investigator’s opinion, the history/predisposition should not jeopardize patient’s safety during the study.
What rules you out
- Part I and Part II: Patient has received or is scheduled to receive total body irradiation; total nodal irradiation; upper abdomen radiotherapy; half or upper body irradiation; or radiotherapy of the cranium, craniospinal regions, head and neck, lower thorax region, or the pelvis within 1 week prior to study entry (Day 1) or within 120 h after last study drug administration.
- Part I and Part II: Any illness or condition that, in the opinion of the Investigator, may pose unwarranted risks in administering the investigational product to the patient.
- Part I and Part II: Uncontrolled medical condition (e.g., uncontrolled insulin-dependent diabetes mellitus).
- Part I and Part II: Patient experiencing ongoing vomiting from any organic aetiology (including patients with history of gastric outlet obstruction or intestinal obstruction due to adhesions or volvulus), or patient with hydrocephalus.
- Part I and Part II: Use of any drugs or substances known to interfere with CYP3A4 or CYP2D6 enzymes within 1 week prior to Day 1
- Part I and Part II: Marked baseline prolongation of QTc interval (QTcF>460 millisecond [msec]). At the discretion of the investigator, criterion may be based on automatic interpretation of results.
- Part II: Patient planned to receive multi-day HEC with cycle duration of less than 20 days (less than 20 days between 2 consecutive cycles’ Days 1).
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.