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Study for The Prevention Of Nausea in Cancer Patients Receiving Highly Emetogenic Cisplatin Based Chemotherapy

Primary Purpose

Nausea and Vomiting, Chemotherapy-Induced

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Aprepitant
Ondansetron
GW679769
Dexamethasone
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nausea and Vomiting focused on measuring Nausea, Vomiting, Emesis, Chemotherapy-induced Nausea and Vomiting, CINV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Willing to provide a written informed consent prior to receiving any study-specific procedures or assessments. Diagnosed with a solid malignant tumour and has not previously received chemotherapy. Scheduled to receive chemotherapy conducive to regimens outlined in the study protocol. Exclusion criteria: Not received any investigational product within 30 days of enrolment into the study. Must not be pregnant. Must not be of childbearing potential or is willing to use specific barrier methods outlined in the protocol. Must not be scheduled to receive radiation therapy to the abdomen or to the pelvis within seven (7) days prior to starting study medication. Must not be currently under treatment for a condition which may cause nausea or vomiting (i.e., active peptic ulcer disease, gastric obstruction). Must not have a history of peptic ulcer disease.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

The number of subjects who do not experience vomiting, retching or nausea over a 5 day period following the initiation of chemotherapy.

Secondary Outcome Measures

Routine physical exam findings, vital signs, routine clinical laboratory tests, clinical monitoring and/or observation, and adverse events reporting.

Full Information

First Posted
September 9, 2005
Last Updated
May 6, 2010
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00169572
Brief Title
Study for The Prevention Of Nausea in Cancer Patients Receiving Highly Emetogenic Cisplatin Based Chemotherapy
Official Title
See Detailed Description
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
This study was designed to assess the safety and efficacy of an investigational agent administered in addition to a standard anti-emetic regimen for the treatment of chemotherapy induced nausea and vomiting.
Detailed Description
Phase II Multicentre, Randomised, Double-Blind, Placebo and Active-Controlled, Dose-Ranging, Parallel Group Study of the Safety and Efficacy of The Oral Neurokinin-1 Receptor Antagonist, GW679769 in Combination with Ondansetron Hydrochloride and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Cancer Subjects Receiving Highly Emetogenic Cisplatin-based Chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea and Vomiting, Chemotherapy-Induced
Keywords
Nausea, Vomiting, Emesis, Chemotherapy-induced Nausea and Vomiting, CINV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
492 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Aprepitant
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Intervention Type
Drug
Intervention Name(s)
GW679769
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Aprepitant, Ondansetron, GW679769
Primary Outcome Measure Information:
Title
The number of subjects who do not experience vomiting, retching or nausea over a 5 day period following the initiation of chemotherapy.
Secondary Outcome Measure Information:
Title
Routine physical exam findings, vital signs, routine clinical laboratory tests, clinical monitoring and/or observation, and adverse events reporting.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Willing to provide a written informed consent prior to receiving any study-specific procedures or assessments. Diagnosed with a solid malignant tumour and has not previously received chemotherapy. Scheduled to receive chemotherapy conducive to regimens outlined in the study protocol. Exclusion criteria: Not received any investigational product within 30 days of enrolment into the study. Must not be pregnant. Must not be of childbearing potential or is willing to use specific barrier methods outlined in the protocol. Must not be scheduled to receive radiation therapy to the abdomen or to the pelvis within seven (7) days prior to starting study medication. Must not be currently under treatment for a condition which may cause nausea or vomiting (i.e., active peptic ulcer disease, gastric obstruction). Must not have a history of peptic ulcer disease.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
C1437JCP
Country
Argentina
Facility Name
GSK Investigational Site
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1405CBA
Country
Argentina
Facility Name
GSK Investigational Site
City
Salzburg
ZIP/Postal Code
A-5020
Country
Austria
Facility Name
GSK Investigational Site
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
GSK Investigational Site
City
Vienna
ZIP/Postal Code
A-1130
Country
Austria
Facility Name
GSK Investigational Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
GSK Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
GSK Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
GSK Investigational Site
City
Liege
ZIP/Postal Code
4020
Country
Belgium
Facility Name
GSK Investigational Site
City
Santiago
State/Province
Región Metro De Santiago
ZIP/Postal Code
7500921
Country
Chile
Facility Name
GSK Investigational Site
City
Santiago
State/Province
Región Metro De Santiago
Country
Chile
Facility Name
GSK Investigational Site
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
GSK Investigational Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Ostrava - Poruba
ZIP/Postal Code
708 52
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 2
ZIP/Postal Code
12808
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 5
ZIP/Postal Code
154 00
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Praha 8
ZIP/Postal Code
180 81
Country
Czech Republic
Facility Name
GSK Investigational Site
City
Shatin, N.T.
Country
Hong Kong
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1529
Country
Hungary
Facility Name
GSK Investigational Site
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Facility Name
GSK Investigational Site
City
Benevento
State/Province
Campania
ZIP/Postal Code
82100
Country
Italy
Facility Name
GSK Investigational Site
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
GSK Investigational Site
City
Roma
State/Province
Lazio
ZIP/Postal Code
00149
Country
Italy
Facility Name
GSK Investigational Site
City
Roma
State/Province
Lazio
ZIP/Postal Code
00184
Country
Italy
Facility Name
GSK Investigational Site
City
Casalpusterlengo (LO)
State/Province
Lombardia
ZIP/Postal Code
26841
Country
Italy
Facility Name
GSK Investigational Site
City
Sassari
State/Province
Sardegna
ZIP/Postal Code
07100
Country
Italy
Facility Name
GSK Investigational Site
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56124
Country
Italy
Facility Name
GSK Investigational Site
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06156
Country
Italy
Facility Name
GSK Investigational Site
City
Merida
State/Province
Yucatán
ZIP/Postal Code
97500
Country
Mexico
Facility Name
GSK Investigational Site
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
GSK Investigational Site
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
GSK Investigational Site
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
GSK Investigational Site
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Facility Name
GSK Investigational Site
City
Rotterdam
ZIP/Postal Code
3045 PM
Country
Netherlands
Facility Name
GSK Investigational Site
City
Utrecht
ZIP/Postal Code
3527 CE
Country
Netherlands
Facility Name
GSK Investigational Site
City
Karachi
ZIP/Postal Code
54000
Country
Pakistan
Facility Name
GSK Investigational Site
City
Lahore
Country
Pakistan
Facility Name
GSK Investigational Site
City
Callao
ZIP/Postal Code
Callao 1
Country
Peru
Facility Name
GSK Investigational Site
City
Quezon City
ZIP/Postal Code
1101
Country
Philippines
Facility Name
GSK Investigational Site
City
Taft Avenue, Manila
ZIP/Postal Code
1700
Country
Philippines
Facility Name
GSK Investigational Site
City
Bydogoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
GSK Investigational Site
City
Krakow
ZIP/Postal Code
31-115
Country
Poland
Facility Name
GSK Investigational Site
City
Poznan
ZIP/Postal Code
60-569
Country
Poland
Facility Name
GSK Investigational Site
City
Poznan
ZIP/Postal Code
61-866
Country
Poland
Facility Name
GSK Investigational Site
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
GSK Investigational Site
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
GSK Investigational Site
City
Kosice
ZIP/Postal Code
041 90
Country
Slovakia
Facility Name
GSK Investigational Site
City
Nitra
ZIP/Postal Code
949 88
Country
Slovakia
Facility Name
GSK Investigational Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
GSK Investigational Site
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
Facility Name
GSK Investigational Site
City
Tao Yuan County
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

Study for The Prevention Of Nausea in Cancer Patients Receiving Highly Emetogenic Cisplatin Based Chemotherapy

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