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NCT03204279 · ClinicalTrials.gov registry record · Phase 2
PK/PD Study of Netupitant and Palonosetron in Pediatric Patients for Prevention of Chemotherapy-induced Nausea and Vomiting
A Phase 2 study, sponsored by Helsinn Healthcare.
- Completed
- Registry status
- Phase 2
- Development phase
- 67
- Enrollment target
NCT03204279 is a Phase 2 study that has completed, run by Helsinn Healthcare. The registered enrollment target is 67 participants.
The verdict
NCT03204279, a Phase 2 study, has completed, sponsored by Helsinn Healthcare.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 67 participants
- Enrollment target
Study Summary
This study is Phase 2 pharmacokinetic (PK) and pharmacodynamic (PD) dose-finding study of oral netupitant administered concomitantly with oral palonosetron in pediatric cancer patients for the prevention of nausea and vomiting associated with emetogenic chemotherapy. Two different netupitant dosages will be tested in patients aged from 3 months to \< 18 years: 1.33 mg/kg up to a maximum of 100 mg, and 4 mg/kg up to a maximum of 300 mg. All netupitant doses in all age classes will be concomitantly administered with palonosetron 20 μg/kg (up to a maximum dose of 1.5 mg) which is the IV palonosetron dose approved by USA FDA for the pediatric population. The primary objective is to investigate the PK/PD relationship between netupitant exposure (AUC, Cmax) and antiemetic efficacy (CR in delayed phase) after a single oral netupitant administration, concomitantly with oral palonosetron in pediatric cancer patients receiving Moderately Emetogenic Chemotherapy (MEC) or Highly Emetogenic Chemotherapy (HEC) cycles. Efficacy parameter to be used in the correlation is the proportion of patients with Complete Response (CR i.e., no emetic episodes and no rescue medication) during (\> 24-120 h after the start of chemotherapy on Day 1). The secondary objectives are to assess the safety and tolerability after single oral administration of netupitant given concomitantly with a single oral administration of palonosetron; to evaluate the pharmacokinetic (AUC, Cmax, tmax and t1/2) of oral palonosetron at the fixed dose of 20 μg/kg in pediatric patients with the concomitant administration of netupitant. A total of 92 pediatric cancer patients receiving either HEC or MEC will be enrolled in the study.
Interventions
- DRUG Palonosetron
- DRUG Netupitant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2017-08-31 |
| Est. Completion | 2019-09-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03204279
The ClinicalTrials.gov registry entry for NCT03204279 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Helsinn Healthcare, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Palonosetron is the first listed.
NCT03204279 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03204279 about?
NCT03204279 is a clinical study titled "PK/PD Study of Netupitant and Palonosetron in Pediatric Patients for Prevention of Chemotherapy-induced Nausea and Vomiting". This study is Phase 2 pharmacokinetic (PK) and pharmacodynamic (PD) dose-finding study of oral netupitant administered concomitantly with oral palonosetron in pediatric cancer patients for the prevention of nausea and vomiting associated with emetogenic chemotherapy. Two different netupitant dosages...
What is the current status of trial NCT03204279?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2017-08-31. Estimated completion is 2019-09-30.
What interventions are being tested in trial NCT03204279?
The interventions under investigation include: Palonosetron (DRUG), Netupitant (DRUG).
Who is sponsoring clinical trial NCT03204279?
This trial is sponsored by Helsinn Healthcare, which has 18 total clinical trials registered on ClinicalTrials.gov.
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