Know Cancer

or
forgot password

A Phase II, Multicenter,Double-Blind, Randomized Trial of Palonosetron Compared With Granisetron in Preventing Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting in the Chinese Cancer Patients


Phase 2
18 Years
70 Years
Not Enrolling
Both
Chemotherapy-Induced Nausea and Vomiting

Thank you

Trial Information

A Phase II, Multicenter,Double-Blind, Randomized Trial of Palonosetron Compared With Granisetron in Preventing Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting in the Chinese Cancer Patients


Inclusion Criteria:



- Male or female, age ranging from 18 yrs to 70 yrs, with histologically or
cytologically confirmed malignant disease

- naive to chemotherapy or nonnaive with an interval of at least 14 days to the last
one

- Karnofsky index more than 70% and anticipated survival time more than 90 days

- Scheduled to receive any of the following cytotoxic agents based combination
chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2) on study Day 1 and the
chemotherapy should be accomplished on study Day 1

- No emetic episodes and antiemetic medication during the 24 hours preceding
chemotherapy administration

- Adequate organ functions(No impairment to renal, hepatic, cardiac or bone marrow
function )

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

- Provision of written informed consent

Exclusion Criteria:

- Inability to understand or cooperate with study procedures

- Receipt of investigational drugs 30 days before study entry

- Scheduled to receive any drug with antiemetic efficacy from 24 hrs before to 5 days
after treatment

- Contraindications to 5-HT3 receptor antagonists

- Woman Patient with Pregnancy or lactation

- Diagnosed with hypertension or severe infectious diseases

- Obstructive symptom of gastrointestinal tract

- Symptomatic brain metastasis or mental dysfunction

- Baseline QTc > 500 ms

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Supportive Care

Authority:

China: the State Food and Drug Administration

Study ID:

2006L01595

NCT ID:

NCT00666783

Start Date:

Completion Date:

Related Keywords:

  • Chemotherapy-Induced Nausea and Vomiting
  • Nausea
  • Vomiting

Name

Location