- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00687011
Palonosetron Plus Dexamethasone in Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting (Study P04594)
May 12, 2017 updated by: Merck Sharp & Dohme LLC
Open-label Clinical Trial to Assess the Efficacy, Tolerability and Safety of a Single IV Dose of Palonosetron 0.25 mg + Dexamethasone IV in the Prevention of Moderately Emetogenic Chemotherapy-induced Nausea and Vomit (CINV).
The purpose of this study is to determine if a single intravenous (IV) dose of palonosetron 0.25 mg plus a single IV dose of dexamethasone 8 mg is effective to prevent nausea and vomiting induced by moderately emetogenic chemotherapy in subjects with cancer.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
118
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female, >= 18 years of age.
- Histologically or cytologically confirmed malignant disease.
- Naive or non-naive to chemotherapy.
- Karnofsky index >= 70%.
- Scheduled to receive a single dose of at least one of the following agents administered on Study Day 1: any dose of Dactynomicin, Carboplatin, Epirubicin, Idarubicin, Ifosfamide, Irinotecan, Lomustine; or Methotrexate >250 mg/m^2, or Cyclophosphamide <=1500 mg/m^2, or Mitoxantrone <15 mg/m^2, or Doxorubicin >= 20 mg/m^2, or Citarabin > 1g/m^2, Melphalan > 50 mg/m^2 , oxaliplatin > 75 mg/m^2 administered over 1 to 4 hours. The administration of the major chemotherapeutic agent (which is the most emetogenic agent according to the classification of Hesketh, et al., The Oncologist 1999, 4: 191-196) defined Study Day 1 and administration of this agent should not extend beyond 4 hours.
- Provided signed written informed consent.
- Females of childbearing potential must be using reliable contraceptive measures with a negative pregnancy test at the pre-treatment visit.
- If a patient had a known hepatic, renal or cardiovascular impairment and is scheduled to receive the above mentioned chemotherapeutic agents, he/she could be enrolled in this study at the discretion of the investigator.
- If a patient had experienced at maximum mild nausea following any previous chemotherapy regimen, he/she could be enrolled in this study at the discretion of the investigator.
Exclusion Criteria:
- Unable to understand or cooperate with the study procedures.
- Received any investigational drugs within 30 days before study entry.
- Received any drug with potential anti-emetic efficacy within 24 hours of the start of treatment or will be scheduled to receive until Study Day 5 including 5-HT3 receptor antagonists, metoclopramide, phenothiazine anti-emetics (including prochlorperazine, thiethylperazine and perphenazine), scopolamine, diphenhydramine, chlorpheniramine maleate, trimethobenzamide, all benzodiazepines except temazepam or triazolam used once nightly for sleep, haloperidol, droperidol, tetrahydrocannabinol, or nabilone, any corticosteroid including dexamethasone, hydrocortisone, methylprednisolone, prednisone (excluding topical or inhaled preparations).
- Seizure disorder requiring anticonvulsant medication unless clinically stable and free of seizure activity.
- Experienced any vomiting, retching, or NCI Common Toxicity Criteria grade 2 or 3 nausea in the 24 hours preceding chemotherapy.
- Ongoing vomiting from any organic etiology.
- Experienced nausea (moderate or severe) or vomiting following any previous chemotherapy. At the discretion of the investigator, a patient who experienced at maximum mild nausea following any previous chemotherapy might not be excluded from this study.
- Scheduled to receive any dose of cisplatin, carmustine, hexametilamine, dacarbazine, Mecloretamine, Streptozotocin, Procarbazine o Cyclophosphamide > 1500 mg/m^2 or any other chemotherapeutic agent with an emetogenicity level 5 according to the classification of NCCN Guidelines v1 2005 during Study Days 2-6.
- Known contraindication to 5-HT3 receptor antagonists.
- Scheduled to receive radiotherapy of the upper abdomen or cranium during Study Day 2-6.
- QTc > 500 msec at baseline.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Palonosetron-dexamethasone
|
0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent, plus single IV dose of dexamethasone 8 mg administered 15 minutes before chemotherapy (in the event of a shortage of IV dexamethasone, a single oral dose of dexamethasone 20 mg or a single IV dose of methylprednisolone 125 mg could be administered).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients having achieved complete response (CR), defined as no emetic episodes and no rescue medication.
Time Frame: During 24 hours after administration of chemotherapy.
|
During 24 hours after administration of chemotherapy.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients who achieved a CR and of those who achieved complete control; Number of emetic episodes; Time to first emetic episode, to administration and need for rescue therapy; and to treatment failure
Time Frame: Days 1 to 5 at different time intervals for each secondary outcome.
|
Days 1 to 5 at different time intervals for each secondary outcome.
|
Severity of nausea; Patient global satisfaction; Quality of life questionnaire
Time Frame: Days 1 to 5 at different time intervals for each secondary outcome.
|
Days 1 to 5 at different time intervals for each secondary outcome.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 10, 2006
Primary Completion (Actual)
October 27, 2008
Study Completion (Actual)
October 27, 2008
Study Registration Dates
First Submitted
May 27, 2008
First Submitted That Met QC Criteria
May 29, 2008
First Posted (Estimate)
May 30, 2008
Study Record Updates
Last Update Posted (Actual)
May 15, 2017
Last Update Submitted That Met QC Criteria
May 12, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Serotonin Agents
- Serotonin Antagonists
- Serotonin 5-HT3 Receptor Antagonists
- Dexamethasone
- Palonosetron
Other Study ID Numbers
- P04594
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
Study Data/Documents
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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