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A Multi-center, Stratified Randomized, Controlled Study to Evaluate the Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting Associated With Moderate and Highly Emetogenic Chemotherapy in China


Phase 4
18 Years
75 Years
Not Enrolling
Both
Neoplasms, Chemotherapy-Induced Nausea and Vomiting

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Trial Information

A Multi-center, Stratified Randomized, Controlled Study to Evaluate the Efficacy and Safety of Palonosetron Hydrochloride in the Prevention of Nausea and Vomiting Associated With Moderate and Highly Emetogenic Chemotherapy in China


Group I (Highly Emetogenic Chemotherapy): Patients that accepted chemotherapy including
Cisplatin≥50mg/m2, Carmustine>250mg/m2, Cyclophosphamide>1500mg/m2, Dacarbazine>60mg/m2,
Doxorubicin>60mg/m2, Epirubicin>90mg/m2, IFO≥10g/m2 or AC program.

Group II (Moderately Emetogenic Chemotherapy): Patients that accepted chemotherapy including
any dose of Carboplatin, Daunorubicin, Oaliplatin, Irinotecan, or Doxorubicin<60mg/m2(not
include liposomal doxorubicin), Epirubicin≤90mg/m2, Carmustine≤250mg/m2,
Methotrexate≥250mg/m2, Cyclophosphamide≤1500mg/m2, Arabinoside>200mg/m2, IFO<10g/m2,
Cisplatin≥50mg/m2.

Total subjects: 1000, single dose of palonosetron group of 500 patients, repeated doses of
palonosetron group of 500 patients. According to the study subjects receiving highly
emetogenic chemotherapy or moderately emetogenic chemotherapy, subjects are stratified
randomize.


Inclusion Criteria:



1. Patients candidates to a chemotherapy treatment, with histologically or cytologically
confirmed malignant disease;

2. The concrete chemotherapy plan does not limited, group I (Highly Emetogenic
Chemotherapy), group II (Moderately Emetogenic Chemotherapy);

3. Male or female aged 18-75 years, ECOG≤2, estimates survival time≥3 months;

4. WBC≥3.0×109/L, ANC≥1.5×109/L, PLT≥80×109/L, total bilirubin≤1.5×ULN(Normal value
upper limit), AST and ALT≤2.5×ULN(With transferability liver cancer≤5×ULN), Cr and
BUN≤1.5×ULN, electrolyte and electrocardiogram are normal, conforms to the
chemotherapy adaptation;

5. Patients have been apart from the previous chemotherapy to finish above 2 weeks
(including 2 weeks);

6. Patients that voluntarily sign the consent form.

Exclusion Criteria:

1. Pregnancy, or patients during breast feeding;

2. Patients have accepted any radiotherapy during the experimental period;

3. Gastric outlet or intestinal obstruction;

4. Patients have serious heart diseases, liver kidney diseases, or metabolism function
disorder;

5. Patients have epilepsy, or have been used psychotropic drug and calm drug;

6. Received any drugs with potential anti-emetic efficacy, or experienced any vomiting,
nausea or retching in the 24 hours prior to chemotherapy;

7. Patients with transferability brain tumor, have vomiting caused by skull high
pressure, or can not speak sickness situation and adverse reactions by self;

8. Patients have known hypersensitivity to 5-HT3 antagonists;

9. Patients have chemotherapy contraindications;

10. Patients are participating, or have participated in other Clinical studies of new
drugs within 2 weeks.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete Response rate

Outcome Description:

defined as no emetic episode and no use of rescue medication

Outcome Time Frame:

2-7 days

Safety Issue:

No

Authority:

China: Food and Drug Administration

Study ID:

zhiruo

NCT ID:

NCT01481831

Start Date:

July 2011

Completion Date:

Related Keywords:

  • Neoplasms
  • Chemotherapy-Induced Nausea and Vomiting
  • Neoplasms
  • Nausea
  • Vomiting

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