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A Phase II,Multicenter,Randomized,Double-blind,Cross-over Study of Palonosetron Compared With Granisetron in Prevention of Chemotherapy-induced Nausea and Vomiting in Asian Population


Phase 2
18 Years
70 Years
Not Enrolling
Both
Nausea, Vomiting, Chemotherapy

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Trial Information

A Phase II,Multicenter,Randomized,Double-blind,Cross-over Study of Palonosetron Compared With Granisetron in Prevention of Chemotherapy-induced Nausea and Vomiting in Asian Population


Inclusion Criteria:



- Male or female, age ≥ 18 yrs and <70 yrs with histologically or cytologically
confirmed

- Malignant disease

- Naive or nonnaive to chemotherapy, with a Karnofsky score of ≥ 60

- Scheduled to receive two courses of moderately emetogenic chemotherapy or cisplatin
60 ~ 80 mg/m2 on study Day 1

- Use of reliable contraceptive measures (for females of childbearing potential) and
negative pregnancy test at baseline visit

- Patients with hepatic, renal, or cardiovascular impairment eligible at the
investigator's discretion

- Patients experiencing, at maximum, mild nausea after previous chemotherapy eligible
at the investigator's discretion

- Predicted life expectancy of ≥ 3 months

- Provision of written informed consent.

Exclusion Criteria:

- Inability to understand or cooperate with study procedures

- Receipt of investigational drugs ≤ 30 days before study entry

- Receipt of other investigational drugs during the course of this study

- Seizure disorder or any condition requiring anticonvulsants, sedatives

- CNS malignancy or metastasis

- Ongoing emesis due to obstruction of digestive tract

- Emesis, retching, or Grade 2 or 3 nausea 24 hrs before chemotherapy

- Moderate or severe nausea and vomiting after any previous chemotherapy

- Scheduled receipt of any chemotherapeutic agent with an emetogenicity level >3 during
study Days 2-5

- Scheduled receipt of radiotherapy of the upper abdomen or cranium on study Days 2-5

- Scheduled to receive any other drug with potential antiemetic efficacy within 24 h of
study initiation and throughout day 5

- Contraindications to 5-HT3 receptor antagonists

- Contraindications to chemotherapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Complete Protection from Vomiting (ie.Complete Response in Preventing Vomiting)

Outcome Time Frame:

0-24h, 24-120h , 0-120h following chemotherapy

Principal Investigator

Tongyu Lin, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University

Authority:

China: Food and Drug Administration

Study ID:

HJGene_SYat-sen_06_01

NCT ID:

NCT00503386

Start Date:

April 2006

Completion Date:

October 2006

Related Keywords:

  • Nausea
  • Vomiting
  • Chemotherapy
  • chemotherapy-induced nausea and vomiting
  • acute
  • delayed
  • emesis
  • antiemetics
  • 5-HT3 receptor antagonist
  • granisetron
  • palonosetron
  • Nausea
  • Vomiting

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