NCT00359567

Brief Summary

To compare palonosetron with granisetron hydrochloride as a control in the efficacy of intravenous single dose in preventing acute and delayed gastro-intestinal disorders, such as nausea and vomiting induced by highly emetogenic chemotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,140

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

July 7, 2011

Status Verified

July 1, 2011

Enrollment Period

10 months

First QC Date

August 1, 2006

Last Update Submit

July 6, 2011

Conditions

Chemotherapy-Induced Nausea and Vomiting

Keywords

nausea and vomiting

Outcome Measures

Primary Outcomes (1)

  • Complete response (CR: no emetic episodes and no rescue medication) rate in acute and delayed nausea and vomiting

Secondary Outcomes (1)

  • Safety profile

Study Arms (2)

1

EXPERIMENTAL

palonosetron

Drug: palonosetron

2

ACTIVE COMPARATOR

granisetron hydrochloride

Drug: granisetron hydrochloride

Interventions

palonosetronDRUG

intravenous injections of 0.75 mg palonosetron (5 mL) and then granisetron placebo before administration of highly emetogenic chemotherapy, concomitantly administered with corticosteroids.

1
granisetron hydrochlorideDRUG

intravenous injections of palonosetron placebo and then 40μg/kg granisetron hydrochloride before administration of highly emetogenic chemotherapy, concomitantly administered with corticosteroids.

2

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 20 or more at the time when they give consent.
  • Diagnosed as malignant disease.
  • Be naive to chemotherapy or have been treated with single administration of anti-tumor drugs which are classified as low emetogenicity in the first edition of the 2006 NCCN Clinical Practice Guidelines.
  • Cisplatin ≥50 mg/m2 Doxorubicin + cyclophosphamide: AC Epirubicin + cyclophosphamide: EC
  • WBC ≥ 3000 /mm3 AST \< 100 IU/L ALT \< 100 IU/L Creatinine clearance ≥ 60 mL/min
  • Performance Status : 0 - 2

You may not qualify if:

  • Severe (requiring hospitalization) and uncontrollable complications.
  • Metastases to the brain which are symptomatic.
  • Seizure disorder requiring anticonvulsant medication unless clinically stable and free of seizure activity.
  • Symptomatic and invasive procedure indicated ascites or pleural effusion.
  • Have either gastric outlet stenosis or intestinal obstruction.
  • Have ongoing emesis or CTCAE grade 2 or greater nausea.
  • QTc \> 470 msec in the 12-lead ECG within eight days before registration.
  • Known anaphylactic to ingredients of the study drug, namely palonosetron or granisetron hydrochloride injection, or other 5-HT3 receptor antagonists.
  • Known anaphylactic to ingredients of dexamethasone.
  • Pregnant women, breast-feeding women, or any male or female who are not willing to practice adequate contraception during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan

Location

Related Publications (1)

  • Saito M, Aogi K, Sekine I, Yoshizawa H, Yanagita Y, Sakai H, Inoue K, Kitagawa C, Ogura T, Mitsuhashi S. Palonosetron plus dexamethasone versus granisetron plus dexamethasone for prevention of nausea and vomiting during chemotherapy: a double-blind, double-dummy, randomised, comparative phase III trial. Lancet Oncol. 2009 Feb;10(2):115-24. doi: 10.1016/S1470-2045(08)70313-9. Epub 2009 Jan 8.

    PMID: 19135415RESULT

MeSH Terms

Conditions

VomitingNausea

Interventions

PalonosetronGranisetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

QuinuclidinesHeterocyclic Compounds, Bridged-RingHeterocyclic CompoundsIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAzabicyclo CompoundsAza CompoundsOrganic ChemicalsIndazolesPyrazolesAzolesHeterocyclic Compounds, 1-RingBridged Bicyclo Compounds, Heterocyclic

Study Officials

  • Tomohide Tamura, MD

    National Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 1, 2006

First Posted

August 2, 2006

Study Start

July 1, 2006

Primary Completion

May 1, 2007

Study Completion

August 1, 2007

Last Updated

July 7, 2011

Record last verified: 2011-07

Locations

JP(1)