Nausea and Vomiting, Chemotherapy-InducedPhase 2NCT00104403
Study Of Prevention of Chemo-Induced Nausea and Vomiting Caused By Moderately Emetogenic Chemotherapy
A Phase 2 study testing GW679769, Dexamethasone and Ondansetron Hydrochloride in people with Nausea and Vomiting, Chemotherapy-Induced and Chemotherapy-Induced Nausea and Vomiting, run by GlaxoSmithKline at 113 sites in 24 countries.
Trial summary
This study was designed to assess the safety and efficacy of different dosages and administration schedules of an investigational agent administered over 3 days when added to standard therapy used in the prevention of chemotherapy-induced nausea and vomiting in cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nausea and Vomiting, Chemotherapy-Induced, Chemotherapy-Induced Nausea and Vomiting
- What is being tested?
- GW679769, Dexamethasone and Ondansetron Hydrochloride
- How many people
- 722 participants
- Where
- 113 sitesin 24 countries
- Study dates
- Dec 2004to Jan 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to provide a written informed consent prior to receiving any study-specific procedures or assessments.
- Diagnosed with a solid malignant tumor and has not previously received chemotherapy.
- Scheduled to receive chemotherapy conducive to regimens outlined in the study protocol.
Who cannot join
- Not received any investigational product within 30 days of enrollment 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.
Trial locations and contacts
113 sites in 24 countries.
113 sites in 24 countries
United States47 sites
GSK Investigational Site
Abingdon, Virginia, 24211
GSK Investigational Site
Akron, Ohio, 44304
GSK Investigational Site
Alexandria, Louisiana, 71301
GSK Investigational Site
Baton Rouge, Louisiana, 70809
GSK Investigational Site
Bay City, Michigan, 48708
GSK Investigational Site
Bethesda, Maryland, 20817
GSK Investigational Site
Birmingham, Alabama, 35209
GSK Investigational Site
Bismarck, North Dakota, 58503
GSK Investigational Site
Boynton Beach, Florida, 33435
GSK Investigational Site
Burlington, Vermont, 05401
GSK Investigational Site
Canton, Ohio, 44718
GSK Investigational Site
Centralia, Illinois, 62801
GSK Investigational Site
Corona, California, 92882
GSK Investigational Site
Corpus Christi, Texas, 78463-3069
GSK Investigational Site
Dallas, Texas, 75237
GSK Investigational Site
Evansville, Indiana, 47713
GSK Investigational Site
Everett, Washington, 98201
GSK Investigational Site
Greenbrae, California, 94904-2007
GSK Investigational Site
Houston, Texas, 77024
GSK Investigational Site
Hudson, Florida, 34667
GSK Investigational Site
Hutchinson, Kansas, 67502
GSK Investigational Site
Jefferson City, Missouri, 65109
GSK Investigational Site
Lakewood, Colorado, 80215
GSK Investigational Site
Loma Linda, California, 92354
GSK Investigational Site
Los Angeles, California, 90057
GSK Investigational Site
Miami, Florida, 33138
GSK Investigational Site
Muncie, Indiana, 47303
GSK Investigational Site
New Albany, Indiana, 47150
GSK Investigational Site
Ocala, Florida, 34474
GSK Investigational Site
Ogden, Utah, 84403
GSK Investigational Site
Palm Springs, California, 92262
GSK Investigational Site
Park Ridge, Illinois, 60068
GSK Investigational Site
Rhinelander, Wisconsin, 54501
GSK Investigational Site
Richmond, Virginia, 23230
GSK Investigational Site
Rochester, New York, 14621
GSK Investigational Site
Rolla, Missouri, 65401
GSK Investigational Site
Skokie, Illinois, 60076
GSK Investigational Site
Sparta, New Jersey, 07871
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
Sumter, South Carolina, 29150
GSK Investigational Site
Tacoma, Washington, 98405
GSK Investigational Site
Tacoma, Washington, 98431
GSK Investigational Site
The Bronx, New York, 10467-2490
GSK Investigational Site
Tupelo, Mississippi, 38801
GSK Investigational Site
Tyler, Texas, 75708
GSK Investigational Site
West Point, Utah, 84341
GSK Investigational Site
Worcester, Massachusetts, 01608
Ireland6 sites
GSK Investigational Site
Dublin, 4
GSK Investigational Site
Dublin, 7
GSK Investigational Site
Dublin, 8
GSK Investigational Site
Dublin, 9
GSK Investigational Site
Tallaght, Dublin, 24
GSK Investigational Site
Tullamore
Canada5 sites
GSK Investigational Site
Charlottetown, Prince Edward Island, C1A 8T5
GSK Investigational Site
Greenfield Park, Quebec, J4V 2H1
GSK Investigational Site
Kitchener, Ontario, N2G 1G3
GSK Investigational Site
Oshawa, Ontario, L1G 2B9
GSK Investigational Site
Québec, Quebec, G1J 1Z4
Czechia5 sites
GSK Investigational Site
Hradec Králové, 500 05
GSK Investigational Site
Ostrava - Poruba, 708 52
GSK Investigational Site
Prague, 100 00
GSK Investigational Site
Prague, 154 00
GSK Investigational Site
Prague, 180 00
United Kingdom5 sites
GSK Investigational Site
Cardiff, Glamorgan, CF14 2TL
GSK Investigational Site
Chelmsford, Essex, CM1 7ET
GSK Investigational Site
Edinburgh, Midlothian, EH4 2XU
GSK Investigational Site
Exeter, Devon, EX2 5DW
GSK Investigational Site
Shrewsbury, SY3 8XQ
Poland4 sites
GSK Investigational Site
Kielce, 25-640
GSK Investigational Site
Olsztyn, 10-228
GSK Investigational Site
Opole, 45-060
GSK Investigational Site
Szczecin, 71-730
Russia4 sites
GSK Investigational Site
Moscow, 115 478
GSK Investigational Site
Moscow, 117997
GSK Investigational Site
Moscow, 129301
GSK Investigational Site
Moscow Region, 143 423
Spain4 sites
GSK Investigational Site
Madrid, 28034
GSK Investigational Site
Marid, 28040
GSK Investigational Site
Pontevedra, 36071
GSK Investigational Site
Valencia, 46009
Austria3 sites
GSK Investigational Site
Salzburg, A-5020
GSK Investigational Site
Vienna, A-1090
GSK Investigational Site
Vienna, A-1130
Chile3 sites
GSK Investigational Site
Santiago, Región Metro de Santiago, 7500921
GSK Investigational Site
Santiago, Región Metro de Santiago, 8380456
GSK Investigational Site
Santiago, Región Metro de Santiago
Germany3 sites
GSK Investigational Site
Essen, North Rhine-Westphalia, 45122
GSK Investigational Site
Munich, Bavaria, 81675
GSK Investigational Site
Regensburg, Bavaria, 93049
Greece3 sites
GSK Investigational Site
Athens, 115 22
GSK Investigational Site
Haidari, 124 61
GSK Investigational Site
Thessaloniki, 564 29
Taiwan3 sites
GSK Investigational Site
Tainan, 704
GSK Investigational Site
Taipei, 100
GSK Investigational Site
Taipei, 104
Argentina2 sites
GSK Investigational Site
Buenos Aires, C1405CBA
GSK Investigational Site
Capital Federal, Buenos Aires, C1437JCP
Hungary2 sites
GSK Investigational Site
Budapest, 1529
GSK Investigational Site
Mátraháza, 3233
Mexico2 sites
GSK Investigational Site
Durango, Durango, 34000
GSK Investigational Site
Mérida, Yucatán, 97500
Pakistan2 sites
GSK Investigational Site
Karachi, 54000
GSK Investigational Site
Lahore
Philippines2 sites
GSK Investigational Site
Quezon City, 1101
GSK Investigational Site
Taft Avenue, Manila, 1700
Slovakia2 sites
GSK Investigational Site
Bratislava, 833 10
GSK Investigational Site
Žilina, 010 01
Thailand2 sites
GSK Investigational Site
Bangkok, 10400
GSK Investigational Site
Chiang Mai, 50200
About this study
Official title: A Phase II Multicenter, Randomized, Double-blind, Placebo-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
This study was designed to assess the safety and efficacy of different dosages and administration schedules of an investigational agent administered over 3 days when added to standard therapy used in the prevention of chemotherapy-induced nausea and vomiting in cancer patients. Subjects will be asked to complete daily diaries while on study medication. In addition subjects will be required to return to the investigational site several times during the course of the study for follow up safety assessments which may include blood samples for hematology and chemistry evaluations as well as physical exams. A final assessment will be preformed on study Day 20-30 at which time the subject will complete the study.
Read the detailed description
A Phase II Multicenter, Randomized, Double-blind, Placebo-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 Moderately Emetogenic Chemotherapy
- Being tested
- GW679769, Dexamethasone, Ondansetron Hydrochloride
- Keywords
- Vomiting, CINV, Emesis, Nausea, Chemotherapy-Induced Nausea and Vomiting
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW679769Drug
DexamethasoneDrug
Ondansetron HydrochlorideDrug
Also called GW679769, Dexamethasone
What is being measured
The primary outcome is the main question the study is designed to answer.
Based on the number of subjects who do not experience vomiting, retching or nausea over a 5 day period following the initiation of chemotherapy.
Secondary outcomes (1)
Based on routine physical exam findings, vital signs, routine clinical laboratory tests, clinical monitoring and/or observation, and adverse events reporting performed during scheduled visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2005 (estimated)
- Study startDec 2004
- Primary completionJan 2006
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nausea and Vomiting, Chemotherapy-InducedStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 722 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00104403
- Sponsor's protocol ID
- NKV101983
- Status last verified
- Apr 2015
- First submitted
- 28 Feb 2005
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Arpornwirat W, Albert I, Hansen VL, Levin J, Bandekar RR, Grunberg SM. Phase 2 trial results with the novel neurokinin-1 receptor antagonist casopitant in combination with ondansetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in cancer patients receiving moderately emetogenic chemotherapy. Cancer. 2009 Dec 15;115(24):5807-16. doi: 10.1002/cncr.24630.
PubMed 19834961
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multicenter, Randomized, Double-blind, Placebo-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
- ClinicalTrials.gov ID
- NCT00104403
- Acronym / sponsor ID
- NKV101983
- Keywords
- Vomiting, CINV, Emesis, Nausea, Chemotherapy-Induced Nausea and Vomiting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 722 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 1 Mar 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to assess the safety and efficacy of different dosages and administration schedules of an investigational agent administered over 3 days when added to standard therapy used in the prevention of chemotherapy-induced nausea and vomiting in cancer patients. Subjects will be asked to complete daily diaries while on study medication. In addition subjects will be required to return to the investigational site several times during the course of the study for follow up safety assessments which may include blood samples for hematology and chemistry evaluations as well as physical exams. A final assessment will be preformed on study Day 20-30 at which time the subject will complete the study.
Detailed description
A Phase II Multicenter, Randomized, Double-blind, Placebo-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 Moderately Emetogenic Chemotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing to provide a written informed consent prior to receiving any study-specific procedures or assessments.
- Diagnosed with a solid malignant tumor and has not previously received chemotherapy.
- Scheduled to receive chemotherapy conducive to regimens outlined in the study protocol.
Key exclusion criteria (6 listed)
- Not received any investigational product within 30 days of enrollment 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GW679769 | Drug | – |
| Dexamethasone | Drug | – |
| Ondansetron HydrochlorideAlso: GW679769, Dexamethasone | Drug | – |
Primary outcome
Based on the number of subjects who do not experience vomiting, retching or nausea over a 5 day period following the initiation of chemotherapy.
1 secondary outcome
Based on routine physical exam findings, vital signs, routine clinical laboratory tests, clinical monitoring and/or observation, and adverse events reporting performed during scheduled visits.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
- Results publication: PubMed 19834961Arpornwirat W, Albert I, Hansen VL, Levin J, Bandekar RR, Grunberg SM. Phase 2 trial results with the novel neurokinin-1 receptor antagonist casopitant in combination with ondansetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in cancer patients receiving moderately emetogenic chemotherapy. Cancer. 2009 Dec 15;115(24):5807-16. doi: 10.1002/cncr.24630.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
113 sites in 24 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW679769, Dexamethasone and Ondansetron Hydrochloride in people with Nausea and Vomiting, Chemotherapy-Induced and Chemotherapy-Induced Nausea and Vomiting, run by GlaxoSmithKline at 113 sites in 24 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 113 sites in United States, Ireland, Canada, Czechia, United Kingdom and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Based on the number of subjects who do not experience vomiting, retching or nausea over a 5 day period following the initiation of chemotherapy.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00104403, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2015.