The Efficacy and Safety of Palonosetron in Preventing the Gastrointestinal Reactions Induced by 3-day Highly Emetogenic Chemotherapy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01909856

Enrollment

Registered

2013-07-29

Start date

2011-10-31

Completion date

2014-06-30

Last updated

2015-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Brief summary

This study is to assess the efficacy and safety of palonosetron in preventing the acute and delayed emesis induced by 3-day highly emetogenic chemotherapy. A double-blind, crossover design is used and granisetron is the positive control.

Interventions

DRUGPalonosetron

Palonosetron 0.25mg d1,d3

DRUGGranisetron

Granisetron 3mg d1-3

DRUGDexamethasone

Dexamethasone 10mg d1-3

DRUGCisplatin

3-day chemotherapy regimens including cisplatin, cisplatin: 25mg/m2 d1-3

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Patients diagnosed with malignant tumors who can receive 3-day chemotherapy regimens defined by the protocol; * The two-cycle sequential chemotherapy must be the same in drugs, dosage, sequence and routes of administration; * Patients are prohibited from any other chemotherapy drugs during the study, as well as other antiemesis, sedative and psychotropic drugs within 5 days after chemotherapy; * Life expectancy ≥ 3 months; * Adequate hematologic function; * Adequate hepatic function; * Adequate renal function; * At least 2 weeks away from the last chemotherapy; * Patients signed written informed consent.

Exclusion criteria

* Pregnant or lactating women; * History of anticipatory vomiting; * Radiation therapy on the abdomen or pelvis within one week prior to study entry; * Concomitant use of other drugs which may affect the antiemetic effects (such as omeprazole, amifostine, etc.); * Patients with gastrointestinal obstruction; * Patients with severe heart disease, liver or renal disease, or metabolism disorders; * Patients with epilepsy or using sedative or psychotropic drugs; * Patients with diabetes or with contraindication for corticosteroids; * Patients who received antiemetic drugs or experienced nausea or vomiting within 24 hours prior to study entry; * Patients with brain metastasis or intracranial hypertension; * Hypersensitivity to 5-HT3 receptor antagonist; * Patients with active infection; * Other conditions that the investigator considered as unsuitable for chemotherapy; * Subjects participating in other clinical trials.

Design outcomes

Primary

Measure	Time frame
Complete Response(CR) within 24-120 hours after chemotherapy	24-120 hours

Secondary

Measure	Time frame
CR within 0-120 hours after chemotherapy	0-120 hours
CR within 0-24 hours after chemotherapy	0-24 hours
Incidence of Adverse events	up to 3 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026