Palonosetron in Moderately and Highly Emetogenic Chemotherapy Induced Nausea and Vomiting (Study P04935)(COMPLETED)

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00684463
• Other study ID #: P04935
• Status: Completed
• Phase: Phase 4
• First received: May 22, 2008
• Last updated: May 15, 2017
• Start date: April 11, 2007
• Est. completion date: February 22, 2008

Study information

• Verified date: May 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: February 22, 2008
• Est. primary completion date: February 22, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Neoplasms
• Vomiting

Intervention

Drug:
• Palonosetron
0.25 mg IV single dose, 30 minutes prior to the administration of the major chemotherapeutic agent.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients having achieved complete response (CR), defined as no emetic episodes and no rescue medication.		During 24 hours after administration of chemotherapy.
Secondary	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.
Secondary	Number of emetic episodes		Days 1 to 5 at different time intervals for each secondary outcome.
Secondary	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.