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Completed

NCT Number: NCT00684463

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

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.

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Key information

Conditions

Neoplasms Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Palonosetron

Drug

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

Other names: SCH 734291 - Onicit®

Primary outcomes

  1. 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

  1. Proportion of patients who achieved a CR and of those who achieved complete control

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

  2. Number of emetic episodes

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

  3. 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

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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 26, 2008
Registry last updated
May 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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