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Clinical Trials/NCT00684463
NCT00684463CompletedPhase 4

Study to Evaluate the Efficacy and Safety of Single IV Doses of Onicit® (Palonosetron) 0.25 mg in the Prevention of Acute and Delayed Nausea and Vomiting Associated With Moderate and Highly Emetogenic Chemotherapy in Colombia

Merck Sharp & Dohme LLC0 sites59 target enrollmentStarted: April 11, 2007Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
59
Primary Endpoint
Proportion of patients having achieved complete response (CR), defined as no emetic episodes and no rescue medication.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of single IV doses of Onicit® (Palonosetron) 0.25 mg in the prevention of acute and delayed nausea and vomiting associated with moderate and highly emetogenic chemotherapy.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients must be 18 years of age or older.
  • •Histological or cytological confirmation of malignant disease.
  • •Karnofsky index >= 50%
  • •Naïve to chemotherapy (First Cycle of chemotherapy IV with moderate or high emetic risk administered during Day 1 of the study, according to modification of the classification of Paul Hesketh's schema published on Annals of Oncology 17: 20-28, 2006 (Appendix 3).
  • •Patients that voluntarily sign the consent form.

Exclusion Criteria

  • •Pregnancy or suspected.
  • •Patients during breast feeding.
  • •Inability 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 prior to the beginning of the treatment
  • •Seizure disorders requiring anticonvulsant medication.
  • •Persistent vomiting due to any organic etiology.
  • •Experienced any vomiting, nausea or retching, in the 24 hours prior to chemotherapy.
  • •Any systemic disease different to base disease
  • •Known current or history of drug or alcohol abuse
  • •Gastric outlet or intestinal obstruction

Arms & Interventions

Palonosetron

Experimental

0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent

Intervention: Palonosetron (Drug)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Time to first emetic episode; time to administration and need for rescue therapy; and to treatment failure time to first emetic episode or administration of rescue medication(Days 1 to 5 at different time intervals for each secondary outcome.)
  • Number of emetic episodes(Days 1 to 5 at different time intervals for each secondary outcome.)
  • Proportion of patients who achieved a CR and of those who achieved complete control(Days 1 to 5 at different time intervals for each secondary outcome.)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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