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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


Phase 4
18 Years
N/A
Not Enrolling
Both
Neoplasms, Nausea, Vomiting

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Proportion of patients having achieved complete response (CR), defined as no emetic episodes and no rescue medication.

Outcome Time Frame:

During 24 hours after administration of chemotherapy.

Safety Issue:

No

Authority:

Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Study ID:

P04935

NCT ID:

NCT00684463

Start Date:

April 2007

Completion Date:

February 2008

Related Keywords:

  • Neoplasms
  • Nausea
  • Vomiting
  • Antiemetic
  • Neoplasms
  • Nausea
  • Vomiting

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