Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Palonosetron in Cancer Treated With Platinum Chemotherapy
This study has been completed.
Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT01046240
First received: November 24, 2009
Last updated: November 14, 2012
Last verified: November 2012
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Purpose
This trial compares the pharmacokinetics of palonosetron administered subcutaneously and intravenously.
| Condition | Intervention | Phase |
|---|---|---|
|
Emesis |
Drug: Palonosetron |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Randomized Crossover Pharmacokinetic Evaluation of Subcutaneous Versus Intravenous Palonosetron in Cancer Patients Treated With Platinum Based Chemotherapy |
Resource links provided by NLM:
Further study details as provided by Clinica Universidad de Navarra, Universidad de Navarra:
Primary Outcome Measures:
- To assess the pharmacokinetics of a single dose of palonosetron 3mg administered either subcutaneously or intravenously by assessment of area under the curve and Cmax in cancer patients treated with emetogenic chemotherapy. [ Time Frame: Palonosetron levels will be assessed at 10 , 15, 30, 45, 60 min. and 12 and 24 hours following treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To compare the efficacy of a single dose of palonosetron 3mg administered either subcutaneously or intravenously by assessment of number of episodes of nausea and vomiting in cancer patients treated with emetogenic chemotherapy. [ Time Frame: 1 week (post-chemotherapy) ] [ Designated as safety issue: No ]
| Enrollment: | 29 |
| Study Start Date: | October 2009 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Intravenous granisetron
Intravenous granisetron
|
Drug: Palonosetron
Palonosetron 3 mg administered SC or IV
|
|
Experimental: subcutaneous palonosetron
subcutaneous palonosetron
|
Drug: Palonosetron
Palonosetron 3 mg administered SC or IV
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Cancer patients receiving platinum-based chemotherapy adequate bone marrow, hepatic and renal function
Exclusion Criteria:
- Pregnancy
- Serious concomitant diseases, in the invesgator´s criteria
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01046240
Locations
| Spain | |
| Clinica Universidad de Navarra | |
| Pamplona, Navarra, Spain, 31008 | |
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Investigators
| Principal Investigator: | Belen Sadaba, MD, PhD | Clinica Universidad de Navarra |
More Information
No publications provided
| Responsible Party: | Clinica Universidad de Navarra, Universidad de Navarra |
| ClinicalTrials.gov Identifier: | NCT01046240 History of Changes |
| Other Study ID Numbers: | PAL/SC-IV-2008, 2008-002853-19 |
| Study First Received: | November 24, 2009 |
| Last Updated: | November 14, 2012 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
|
chemotherapy emesis palonosetron |
Additional relevant MeSH terms:
|
Vomiting Signs and Symptoms, Digestive Signs and Symptoms Palonosetron Serotonin Antagonists |
Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013