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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00891761 |
This is a phase III study designed to demonstrate the superiority of single-dose 90 mg intravenous (IV) casopitant over placebo, each in combination with ondansetron and dexamethasone, for the prevention of emesis over the first 0-120 hours (overall phase) following initiation of the cisplatin infusion in the first cycle of highly emetogenic chemotherapy (HEC). Eligibility is limited to subjects who are scheduled to receive their first cycle of chemotherapy which includes at least 60 mg/m2 of cisplatin administered on Day 1 only of a 21 day or 28 day cycle. All subjects will receive IV ondansetron and oral dexamethasone on Day 1 prior to initiation of the cisplatin infusion, followed by oral dexamethasone on Days 2-4. Additionally, subjects will be randomized to receive single-dose 90 mg IV casopitant or matching placebo prior to initiation of a cisplatin-based HEC regimen.
Condition | Intervention | Phase |
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Cancer Chemotherapy-Induced Nausea and Vomiting Nausea and Vomiting Solid Tumor Cancer |
Drug: Dexamethasone Drug: IV casopitant (placebo) Drug: IV casopitant (active) Drug: Ondansetron |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Study of Single Dose Intravenous Casopitant in Combination With Ondansetron and Dexamethasone for the Prevention of Cisplatin-Induced Nausea and Vomiting |
Estimated Enrollment: | 436 |
Study Start Date: | June 2009 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Active Comparator: Active Comparator
Patients receive IV casopitant (active), IV ondansetron and oral dexamethasone on Day 1 as well as oral dexamethasone on Days 2-4 of each cycle of cisplatin-based highly emetogenic chemotherapy for the prevention of chemotherapy induced nausea and vomiting.
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Drug: Dexamethasone
16 mg administered orally within 75 minutes prior to the initiation of cisplatin on Day 1, followed by 8 mg doses twice daily (bid) at approximately 12+/-4 hour intervals on days 2, 3, and 4, starting at approximately the same time of day as the Day 1 dose was administered.
Drug: IV casopitant (active)
Single-dose 90 mg IV casopitant administered within 75 minutes prior to the start of cisplatin-based highly emetogenic chemotherapy on study Day 1.
Drug: Ondansetron
32mg IV ondansetron administered over not less than 15 minutes, with administration started and completed within the 75 minutes prior to the initiation of cisplatin therapy on study Day 1.
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Placebo Comparator: Placebo Comparator
Patients receive IV casopitant (placebo), IV ondansetron and oral dexamethasone on Day 1 as well as oral dexamethasone on Days 2-4 of each cycle of cisplatin-based highly emetogenic chemotherapy for the prevention of chemotherapy induced nausea and vomiting.
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Drug: Dexamethasone
20 mg administered orally within 75 minutes prior to the initiation of cisplatin on Day 1, followed by 8 mg doses twice daily (bid) at approximately 12+/-4 hour intervals on days 2, 3, and 4, starting at approximately the same time of day as the Day 1 dose was administered.
Drug: IV casopitant (placebo)
IV casopitant (placebo) administered within 75 minutes prior to the start of cisplatin-based highly emetogenic chemotherapy on study day 1.
Drug: Ondansetron
32mg IV ondansetron administered over not less than 15 minutes, with administration started and completed within the 75 minutes prior to the initiation of cisplatin therapy on study Day 1.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A subject will be considered eligible for initial inclusion in this study, and progression into subsequent cycles of therapy within the study, only if all of the following criteria apply:
Creatinine clearance must be calculated using the Cockcroft-Gault formula:
Clcreat (ml/min) = (140-age [yr]) x body wt [kg] / 72 x serum creatinine [mg/dl] For females: multiply creatinine clearance by a factor of 0.85. OR Clcreat (ml/min) = K x (140-age [yr]) x body wt [kg] / serum creatinine [µmol/L] K=1.05 for females K=1.23 for males
Exclusion Criteria:
A subject will not be eligible for initial inclusion in this study if any of the following criteria apply, or will not be eligible for subsequent cycles of therapy if any of the following criteria become applicable:
Radiation therapy may be added in subsequent cycles of chemotherapy.
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 112512 |
Study First Received: | April 30, 2009 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00891761 History of Changes |
Health Authority: | Czech Republic: Státní ústav pro kontrolu léčiv, Oddělení klinického hodnocení; Europe: European Medicines Agency; Hungary: Országos Gyógyszerészeti Intézet; Poland: URZ.D REJESTRACJI PRODUKTÓW LECZNICZYCH, WYROBÓW MEDYCZNYCH I PRODUKTÓW BIOBÓJCZYCH,CEBK; Russia: Russian Ministry of Health; South Korea: Food and Drug Administration; Thailand: Ministry of Public Health; United States: Food and Drug Administration; Bulgaria: The Bulgarian Drug Agency; Canada: Health Canada |
cisplatin nausea vomiting cancer lung cancer |
Dexamethasone Anti-Inflammatory Agents Neurotransmitter Agents Vomiting Signs and Symptoms, Digestive Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Psychotropic Drugs Antiemetics Hormones Signs and Symptoms Cisplatin Lung Neoplasms |
Antipruritics Nausea Ondansetron Dexamethasone acetate Tranquilizing Agents Antineoplastic Agents, Hormonal Central Nervous System Depressants Antipsychotic Agents Glucocorticoids Serotonin Radiation-Sensitizing Agents Anti-Anxiety Agents Peripheral Nervous System Agents |
Dexamethasone Anti-Inflammatory Agents Neurotransmitter Agents Vomiting Molecular Mechanisms of Pharmacological Action Signs and Symptoms, Digestive Antineoplastic Agents Physiological Effects of Drugs Psychotropic Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Signs and Symptoms Serotonin Antagonists Cisplatin |
Therapeutic Uses Antipruritics Nausea Ondansetron Dermatologic Agents Dexamethasone acetate Tranquilizing Agents Antineoplastic Agents, Hormonal Gastrointestinal Agents Central Nervous System Depressants Antipsychotic Agents Glucocorticoids Pharmacologic Actions Serotonin Agents Radiation-Sensitizing Agents |