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

NCT00684463 | Completed Phase 4

• 1 other identifier: P04935
• Study Type: interventional
• Target: 59
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neoplasms; Nausea; Vomiting

Keywords

Antiemetic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

• Number of emetic episodes

  Days 1 to 5 at different time intervals for each secondary outcome.

• 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.

Study Arms (1)

Palonosetron

EXPERIMENTAL

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

Drug: Palonosetron

Interventions

Palonosetron DRUG

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

Also known as: SCH 734291 - Onicit®

Palonosetron

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Neoplasms; Nausea; Vomiting

Interventions

Palonosetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2008
• First Posted: May 26, 2008
• Study Start: April 11, 2007
• Primary Completion: February 22, 2008
• Study Completion: February 22, 2008
• Last Updated: May 16, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share