Clinical Trials Logo

Clinical Trial Summary

This trial compares the pharmacokinetics of palonosetron administered subcutaneously and intravenously.


Clinical Trial Description

5-Hydroxitryptamine3 antagonists are one of the mainstays of antiemetic treatment and they are administered either intravenously or orally. Nevertheless sometimes neither administration route is feasible, such as in patients unable to admit oral intake managed in an outpatient setting. Our objective is to evaluate the bioavailability of subcutaneous palonosetron.Patients receiving platinum-based chemotherapy will be randomized to receive palonosetron 3 mg either subcutaneously or intravenously in a crossover manner during two cycles. Blood and urine samples will be collected after each cycle. Pharmacokinetics of subcutaneous and IV palonosetron will be prospectively compared. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT01046240
Study type Interventional
Source Clinica Universidad de Navarra, Universidad de Navarra
Contact
Status Completed
Phase Phase 1/Phase 2
Start date October 2009
Completion date November 2010

See also
  Status Clinical Trial Phase
Active, not recruiting NCT01913990 - Prevention of Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients. Phase 4
Terminated NCT00869973 - Aprepitant in the Prevention of Delayed Emesis Induced by Cyclophosphamide Plus Anthracyclines in Breast Cancer Patients Phase 3
Terminated NCT00869310 - Aprepitant in the Prevention of Cisplatin-induced Delayed Emesis Phase 3
Completed NCT04719286 - MinSafeStart - Decision Aid Tool for Better Treatment of Nausea and Vomiting During Pregnancy N/A
Recruiting NCT03478605 - Trial to Evaluate Efficacy of Olanzapine With Short-acting 5HT3 Inhibitors in Chemotherapy-induced Nausea & Vomiting (CINV) Prophylaxis Phase 2
Recruiting NCT04564144 - Evaluation of Meclizine Orodispersible Tablet Pharmacokinetic in Human Volunteers Phase 1/Phase 2
Terminated NCT01148264 - Comparison of Olanzapine and Metoclopramide For Treatment Of bReakThrough Emesis Phase 2
Completed NCT01509417 - Different Feeding Methods After Pyloromyotomy N/A
Completed NCT00152867 - Dexamethasone Study: Impact on Quality of Life of Continuing Dexamethasone Following Emetogenic Chemotherapy Phase 3
Completed NCT04182750 - Promoting Safe Medication Use in Pregnancy in the Era of Real-World Data - The SafeStart Study N/A
Completed NCT02980289 - DAnish Nausea Study In Advanced Cancer-Epidemiology: A Danish Multicenter Trial to Investigate the Prevalence and Treatment of Nausea and/or Vomiting in Patients With Advanced Cancer.
Completed NCT02602080 - Post- Surgery Recovery: Nerve Blocks w/ Sedation vs. Nerve Block w/ Either Sedation/Gen. Anesthesia
Completed NCT04585841 - The Effect of Cannabidiol on Lean Body Mass in Patients Receiving Chemotherapy Phase 1
Completed NCT01414478 - High Protein Intake to Decrease Emesis and Promote Patient Satisfaction in Labor N/A
Not yet recruiting NCT02407600 - Study Assessing Fosaprepitant in Advanced NSCLC Patients Treated With Carboplatin Based Chemotherapy Phase 2