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AzTrials

VomitingPhase 3NCT00366834

Intravenous And Oral Casopitant (GW679769) For The Prevention Of Chemotherapy Induced Nausea And Vomiting

A Phase 3 study testing Casopitant (GW679769) oral tablets, Casopitant (GW679769) intravenous and Dexamethasone intravenous in people with Vomiting and Nausea, run by GlaxoSmithKline at 223 sites in 32 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a Phase III trial designed to demonstrate that casopitant (GW679769) plus dexamethasone and ondansetron is more effective in the prevention of vomiting than dexamethasone and ondansetron alone following the administration of moderately emetogenic chemotherapy. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Casopitant (GW679769) oral tablets, Casopitant (GW679769) intravenous and Dexamethasone intravenous
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,840 participants
Where
223 sitesin 32 countries
Study dates
Jul 2006to Oct 2009
Phase
Phase 3
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

  • A subject will be considered eligible for inclusion in this study only if all of the following criteria apply:
  • Subject understands the nature and purpose of this study and the study procedures and has signed an informed consent form for this study to indicate this understanding.
  • At least 18 years of age.
  • Is scheduled to receive their first course of an anthracycline and cyclophosphamide containing moderately emetogenic chemotherapy regimen for the treatment of a solid malignant tumor as outlined in Section 8.1.1.
  • Has an ECOG performance status of 0, 1, or 2.
  • Hematologic and metabolic status must be adequate for receiving a moderately emetogenic regimen and meet the following criteria:
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  • Total Neutrophils ≥ 1500/mm³(Standard units : ≥1.5 x 10^9/L)
  • Platelets ≥ 100,000/mm³ (Standard units: ≥100.0 x 10^9/L)
  • Bilirubin ≤ 1.5 x ULN
  • Liver enzymes must be below the following limits:
  • Without known liver metastases: Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal.
  • With known liver metastases: AST and/or ALT ≤ 5.0 x upper limit of normal.
  • Is willing and able to complete daily components of the subject diary for each study cycle.
  • Women of childbearing potential; must commit to consistent and correct use of an acceptable method of birth control; GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of a physician, are as follows:
  • Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal. For purposes of this study, postmenopausal is defined as one year without menses)
  • child-bearing potential: must have a negative serum pregnancy test result or negative urine dipstick pregnancy test within 24 hours prior to the first dose of investigational product of Cycle 1, Day 1 and agrees to one of the following:
  • male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject
  • oral contraceptives (e.g., oral, injectable, or implantable) with double-barrier method of contraception consisting of spermicide with either condom or diaphragm for a period after the trial to account for potential drug interaction (minimum of six weeks)
  • double-barrier method of contraception consisting of spermicide with either condom or diaphragm
  • intra-uterine device (IUD) with a documented failure rate of less than 1% per year
  • complete abstinence from intercourse for two weeks before exposure to the investigational product throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of three days),
  • if subjects indicate they will remain abstinent during the period described above, they must agree to follow GSK guidelines for the consistent and correct use of an acceptable method of birth control should they become sexually active.

Who cannot join

  • Has previously received cytotoxic chemotherapy. A history of previous biological or hormonal therapy will be permitted.
  • Is a female subject who is pregnant or lactating.
  • Has received radiation therapy to the brain, abdomen, or pelvis in the ten days prior to the first dose of study medication or casopitant investigational product and/or will receive radiation therapy to the brain, abdomen, or the pelvis in the six days following the first dose of study medication (ZOFRAN and dexamethasone) or casopitant investigational product.
  • Is scheduled to receive taxane therapy during cycle 1. Note that subjects will be permitted to receive taxane therapy in conjunction with one of the allowed MEC regimens during subsequent cycles.
  • Has experienced emesis (i.e., vomiting and/or retching) or clinically significant nausea in the 24 hours preceding the first dose of study medication or casopitant investigational product.
  • Has a known central nervous system primary or metastatic malignancy, unless successfully treated with excision or radiation and has been medically stable for at least 1 week prior to receiving the first dose of study medication or casopitant investigational product.
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  • Has history of documented peptic ulcer disease (via endoscopy or x-ray), active peptic ulcer disease, gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, or any uncontrolled medical condition (other than malignancy) which in the opinion of the Investigator may confound the results of the study, represent another potential etiology for emesis and nausea (other than CINV) or pose an unwarranted risk to the subject.
  • Has a known hypersensitivity or contraindication to ZOFRAN, another 5-HT3 receptor antagonist, dexamethasone, or any component of casopitant.
  • Has previously received an NK-1 receptor antagonist.
  • Received an investigational drug in the previous 30 days or is scheduled to receive any investigational drug other than casopitant during the study period.
  • Has taken/received any medication of moderate or high emetogenic potential within the 48 hours prior to the first dose of study medication or casopitant investigational product. Opioid narcotics for cancer pain will be permitted if the subject has been on a stable dose and has not experienced emesis or nausea from the narcotics.
  • Has taken/received any medication with known or potential antiemetic activity within the 24-hour period prior to receiving study drug. This includes, but is not limited to:
  • 5-HT3 receptor antagonists (e.g., ondansetron, granisetron, dolasetron, tropisetron, ramosetron). Palonestron is not permitted within 7 days prior to administration of investigational product.
  • benzamide / benzamide derivatives (e.g., metoclopramide, alizapride)
  • benzodiazepines (except if the subject is receiving such medication for sleep or anxiety and has been on a stable dose for at least seven days prior to the first dose of casopitant investigational product; however, lorazepam is prohibited 24 hours prior to receiving study drug regardless of reason for use)
  • phenothiazines (e.g., prochlorperazine, promethazine, fluphenazine, perphenazine, thiethylperazine, chlorpromazine)
  • butyrophenone (e.g., haloperidol, droperidol)
  • corticosteroids (e.g., dexamethasone, methylprednisolone; with the exception of topical steroids for skin disorders, inhaled steroids for respiratory disorders, and prophylactic treatment for taxane therapy during subsequent cycles)
  • anticholinergics (e.g., scopolamine, with the exception of inhaled anticholingerics for respiratory disorders e.g., ipratropium bromide)
  • antihistamines (e.g., cyclizine, hydroxyzine, diphenhydramine), except for prophylactic use for taxane therapy during cycle 2-4
  • domperidone
  • cannabinoids
  • mirtazpine
  • olanzapine
  • Has taken/received strong or moderate inhibitors of CYP3A4 and CYP3A5 for a specified period prior to administration of casopitant investigational product (see Section 8.2.1 "Inhibitors of CYP3A4 and CYP3A5")
  • Has taken/received inducers of CYP3A4 and CYP3A5 within fourteen days prior to the administration of casopitant investigational product. (see Section 8.2.2 "Inducers of CYP3A4 and CYP3A5")
  • Is taking the anti-diabetic agent repaglinide or the diuretic torsemide. Investigators are advised to exercise caution if including patients taking the anti-diabetic agents rosiglitazone or pioglitazone, or antimalarial agents such as chloroquine and amodiaquine, as the metabolite of casopitant is a potential inhibitor of CYP2C8 (See Section 8.2.3 "Substrates for CYP2C8" and Section 8.4 "Necessary Caution with CYP2C8 Substrates").
  • Is currently taking or plans to take the any of the following CYP3A4 substrates: astemizole, cisapride, pimozide, terfenadine.

Trial locations and contacts

223 sites in 32 countries.

223 sites in 32 countries

United States86 sites

  • GSK Investigational Site

    Akron, Ohio, 44304

  • GSK Investigational Site

    Albuquerque, New Mexico, 87109

  • GSK Investigational Site

    Alexandria, Louisiana, 71301

  • GSK Investigational Site

    Augusta, Georgia, 30912

  • GSK Investigational Site

    Baltimore, Maryland, 21229-5299

  • GSK Investigational Site

    Baltimore, Maryland, 21237

  • GSK Investigational Site

    Baton Rouge, Louisiana, 70809

  • GSK Investigational Site

    Bethlehem, Pennsylvania, 18015

  • GSK Investigational Site

    Billings, Montana, 59101

  • GSK Investigational Site

    Birmingham, Alabama, 35209

  • GSK Investigational Site

    Birmingham, Alabama, 35233

  • GSK Investigational Site

    Bismarck, North Dakota, 58501

  • GSK Investigational Site

    Boynton Beach, Florida, 33435

  • GSK Investigational Site

    Brooksville, Florida, 34613

  • GSK Investigational Site

    Buffalo, New York, 14215

  • GSK Investigational Site

    Burlington, Vermont, 05401

  • GSK Investigational Site

    Centralia, Illinois, 62801

  • GSK Investigational Site

    Clinton Township, Michigan, 48038

  • GSK Investigational Site

    Columbus, Georgia, 31904

  • GSK Investigational Site

    Concord, California, 94520

  • GSK Investigational Site

    Corpus Christi, Texas, 78412

  • GSK Investigational Site

    Corpus Christi, Texas, 78463-3069

  • GSK Investigational Site

    Dallas, Texas, 75237

  • GSK Investigational Site

    Denville, New Jersey, 07834

  • GSK Investigational Site

    Durham, North Carolina, 27710

  • GSK Investigational Site

    Evansville, Indiana, 47713

  • GSK Investigational Site

    Everett, Washington, 98201

  • GSK Investigational Site

    Fayetteville, Arkansas, 72703

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33316

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33328

  • GSK Investigational Site

    Fountain Valley, California, 92708

  • GSK Investigational Site

    Free Soil, Michigan, 49411

  • GSK Investigational Site

    Fresno, California, 93710

  • GSK Investigational Site

    Galesburg, Illinois, 61401

  • GSK Investigational Site

    Glendale, Arizona, 85304

  • GSK Investigational Site

    Great Falls, Montana, 59405

  • GSK Investigational Site

    Greenbrae, California, 94904-2007

  • GSK Investigational Site

    Hattiesburg, Mississippi, 39401

  • GSK Investigational Site

    Hazard, Kentucky, 41701

  • GSK Investigational Site

    Hershey, Pennsylvania, 17033

  • GSK Investigational Site

    Hot Springs, Arkansas, 71913

  • GSK Investigational Site

    Huntington, West Virginia, 25701

  • GSK Investigational Site

    Huntington, West Virginia, 25705

  • GSK Investigational Site

    Inverness, Florida, 34452

  • GSK Investigational Site

    Jefferson City, Missouri, 65109

  • GSK Investigational Site

    Jonesboro, Arkansas, 72401

  • GSK Investigational Site

    La Verne, California, 91750

  • GSK Investigational Site

    Lawrenceville, Georgia, 30045

  • GSK Investigational Site

    Lexington, Kentucky, 40503

  • GSK Investigational Site

    Logan, Utah, 84341

  • GSK Investigational Site

    Los Angeles, California, 90057

  • GSK Investigational Site

    Madison, Wisconsin, 53717

  • GSK Investigational Site

    Mason City, Iowa, 50401

  • GSK Investigational Site

    Metairie, Louisiana, 70006

  • GSK Investigational Site

    Miami, Florida, 33179

  • GSK Investigational Site

    Mt. Pleasant, South Carolina, 29464

  • GSK Investigational Site

    Muncie, Indiana, 47303

  • GSK Investigational Site

    New Port Richey, Florida, 34652

  • GSK Investigational Site

    Newark, New Jersey, 07112

  • GSK Investigational Site

    Norwich, Connecticut, 06360

  • GSK Investigational Site

    Ogden, Utah, 84403

  • GSK Investigational Site

    Orange, California, 92868

  • GSK Investigational Site

    Pittsfield, Massachusetts, 01201

  • GSK Investigational Site

    Poway, California, 92064

  • GSK Investigational Site

    Richardson, Texas, 75080

  • GSK Investigational Site

    Rolla, Missouri, 65401

  • GSK Investigational Site

    Saint Joseph, Michigan, 49085

  • GSK Investigational Site

    San Diego, California, 92121

  • GSK Investigational Site

    Sayre, Pennsylvania, 18840

  • GSK Investigational Site

    Skokie, Illinois, 60076

  • GSK Investigational Site

    Somerville, New Jersey, 08876

  • GSK Investigational Site

    Soquel, California, 95073

  • GSK Investigational Site

    Sparta, New Jersey, 07871

  • GSK Investigational Site

    Spokane, Washington, 99204

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Sumter, South Carolina, 29150

  • GSK Investigational Site

    Tacoma, Washington, 98405

  • GSK Investigational Site

    Tamarac, Florida, 33321

  • GSK Investigational Site

    Tampa, Florida, 33614

  • GSK Investigational Site

    Terre Haute, Indiana, 47804

  • GSK Investigational Site

    Troy, Michigan, 48085

  • GSK Investigational Site

    Tupelo, Mississippi, 38801

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20010

  • GSK Investigational Site

    West Palm Beach, Florida, 33401

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

  • GSK Investigational Site

    Worcester, Massachusetts, 01608

Other trials in United States

Canada16 sites

  • GSK Investigational Site

    Charlottetown, Prince Edward Island, C1A 8T5

  • GSK Investigational Site

    Greenfield Park, Quebec, J4V 2H1

  • GSK Investigational Site

    Laval, Quebec, H7M 3L9

  • GSK Investigational Site

    Lévis, Quebec, G6V 3Z1

  • GSK Investigational Site

    Moncton, New Brunswick, E1C 8X3

  • GSK Investigational Site

    Montreal, Quebec, H1T 2M4

  • GSK Investigational Site

    Oshawa, Ontario, L1G 2B9

  • GSK Investigational Site

    Québec, Quebec, G1J 1Z4

  • GSK Investigational Site

    Saskatoon, Saskatchewan, S7N 4H4

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 5N4

  • GSK Investigational Site

    St. John's, Newfoundland and Labrador, A1B 3V6

  • GSK Investigational Site

    Thunder Bay, Ontario, P7B 6V4

  • GSK Investigational Site

    Toronto, Ontario, M5G 1X5

  • GSK Investigational Site

    Toronto, Ontario, M5G2M9

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 4E6

  • GSK Investigational Site

    Windsor, Ontario, N8W 2X3

Other trials in Canada

Germany14 sites

  • GSK Investigational Site

    Bad Berka, Thuringia, 99437

  • GSK Investigational Site

    Berlin, State of Berlin, 10367

  • GSK Investigational Site

    Berlin, State of Berlin, 12163

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 20357

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 22081

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 22457

  • GSK Investigational Site

    Heidelberg, Baden-Wurttemberg, 69126

  • GSK Investigational Site

    Ingolstadt, Bavaria, 85049

  • GSK Investigational Site

    Jena, Thuringia, 07743

  • GSK Investigational Site

    Kassel, Hesse, 34119

  • GSK Investigational Site

    Munich, Bavaria, 80335

  • GSK Investigational Site

    Munich, Bavaria, 81925

  • GSK Investigational Site

    Würselen, North Rhine-Westphalia, 52146

  • GSK Investigational Site

    Würzburg, Bavaria, 97070

Other trials in Germany

Czechia7 sites

  • GSK Investigational Site

    Brno, 656 53

  • GSK Investigational Site

    Chomutov, 43012

  • GSK Investigational Site

    Ostrava - Poruba, 708 52

  • GSK Investigational Site

    Pardubice, 532 03

  • GSK Investigational Site

    Prague, 100 00

  • GSK Investigational Site

    Tábor, 390 19

  • GSK Investigational Site

    Ústí nad Labem, 40113

Other trials in Czechia

Russia7 sites

  • GSK Investigational Site

    Moscow, 115 478

  • GSK Investigational Site

    Moscow, 115478

  • GSK Investigational Site

    Moscow, 117997

  • GSK Investigational Site

    Moscow Region, 143 423

  • GSK Investigational Site

    Saint Petersburg, 198255

  • GSK Investigational Site

    Samara, 443066

  • GSK Investigational Site

    Yaroslavl, 150054

Other trials in Russia

United Kingdom7 sites

  • GSK Investigational Site

    Aberdeen, AB25 2ZN

  • GSK Investigational Site

    Chelmsford, Essex, CM1 7ET

  • GSK Investigational Site

    London, EC1A 7BE

  • GSK Investigational Site

    London, SE1 9RT

  • GSK Investigational Site

    Maidstone, ME16 9QQ

  • GSK Investigational Site

    Nottingham, NG5 1PB

  • GSK Investigational Site

    Shrewsbury, SY3 8XQ

Other trials in United Kingdom

Italy6 sites

  • GSK Investigational Site

    Benevento, Campania, 82100

  • GSK Investigational Site

    Genoa, Liguria, 16132

  • GSK Investigational Site

    Perugia, Umbria, 06156

  • GSK Investigational Site

    Rome, Lazio, 00184

  • GSK Investigational Site

    Sanremo (IM), Liguria, 18038

  • GSK Investigational Site

    Sassari, Sardinia, 07100

Other trials in Italy

South Africa6 sites

  • GSK Investigational Site

    Athlone Park, Amanzimtoti, 4126

  • GSK Investigational Site

    Bloemfontein, 9301

  • GSK Investigational Site

    Observatory, 7925

  • GSK Investigational Site

    Panorama, 7500

  • GSK Investigational Site

    Parktown, 2193

  • GSK Investigational Site

    Saxonwold, Johannesburg, 2196

Other trials in South Africa

Spain6 sites

  • GSK Investigational Site

    Donostia / San Sebastian, 20012

  • GSK Investigational Site

    Madrid, 28034

  • GSK Investigational Site

    Ourense, 32005

  • GSK Investigational Site

    Santiago de Compostela, 15706

  • GSK Investigational Site

    Segovia, 40002

  • GSK Investigational Site

    Zamora

Other trials in Spain

Argentina5 sites

  • GSK Investigational Site

    Capital Federal, Buenos Aires, C1405CUB

  • GSK Investigational Site

    Mendoza, Mendoza Province, M5500AYB

  • GSK Investigational Site

    Quilmes, 1878

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2000KZE

  • GSK Investigational Site

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Austria5 sites

  • GSK Investigational Site

    Salzburg, A-5020

  • GSK Investigational Site

    Sankt Pölten, A-3100

  • GSK Investigational Site

    Vienna, A-1090

  • GSK Investigational Site

    Vienna, A-1130

  • GSK Investigational Site

    Vöcklabruck, A-4840

Other trials in Austria

Greece5 sites

  • GSK Investigational Site

    Athens, 115 22

  • GSK Investigational Site

    Athens, 115 28

  • GSK Investigational Site

    Kavala, 65403

  • GSK Investigational Site

    Pátrai, 26500

  • GSK Investigational Site

    Thessaloniki, 54636

Other trials in Greece

Ireland5 sites

  • GSK Investigational Site

    Dublin, 4

  • GSK Investigational Site

    Dublin, 8

  • GSK Investigational Site

    Dublin, 9

  • GSK Investigational Site

    Tallaght, Dublin, 24

  • GSK Investigational Site

    Wilton, Cork

Other trials in Ireland

Slovakia5 sites

  • GSK Investigational Site

    Bratislava, 812 50

  • GSK Investigational Site

    Bratislava, 833 10

  • GSK Investigational Site

    Nitra, 949 01

  • GSK Investigational Site

    Poprad, 058 01

  • GSK Investigational Site

    Žilina, 010 01

Other trials in Slovakia

Hong Kong4 sites

  • GSK Investigational Site

    Hong Kong

  • GSK Investigational Site

    Shatin

  • GSK Investigational Site

    Tuenmen

  • GSK Investigational Site

    Wan Chai

Other trials in Hong Kong

Philippines4 sites

  • GSK Investigational Site

    Cebu, 6000

  • GSK Investigational Site

    Manila, 1000

  • GSK Investigational Site

    Quezon City, 1100

  • GSK Investigational Site

    Santa Cruz, Manila, 1012

Other trials in Philippines

Taiwan4 sites

  • GSK Investigational Site

    Kaohsiung City, 807

  • GSK Investigational Site

    Tainan, 704

  • GSK Investigational Site

    Taipei, 114

  • GSK Investigational Site

    Taipei

Other trials in Taiwan

Belgium3 sites

  • GSK Investigational Site

    Brussels, 1070

  • GSK Investigational Site

    Ghent, 9000

  • GSK Investigational Site

    Ottignies, 1340

Other trials in Belgium

Bulgaria3 sites

  • GSK Investigational Site

    Plovdiv, 4000

  • GSK Investigational Site

    Shumen, 9700

  • GSK Investigational Site

    Sofia, 1527

Other trials in Bulgaria

Hungary3 sites

  • GSK Investigational Site

    Győr, 9023

  • GSK Investigational Site

    Gyula, 5700

  • GSK Investigational Site

    Veszprém, 8200

Other trials in Hungary

Latvia3 sites

  • GSK Investigational Site

    Liepāja, LV3401

  • GSK Investigational Site

    Riga, LV 1002

  • GSK Investigational Site

    Riga, LV 1079

Other trials in Latvia

Lithuania3 sites

  • GSK Investigational Site

    Kaunas, LT-45434

  • GSK Investigational Site

    Klaipėda, LT-92228

  • GSK Investigational Site

    Vilnius, LT-08660

Other trials in Lithuania

Peru3 sites

  • GSK Investigational Site

    Callao, Callao 2

  • GSK Investigational Site

    Lima, Lima Province, Lima 13

  • GSK Investigational Site

    Lima, Lima Province, Lima 34

Other trials in Peru

Denmark2 sites

  • GSK Investigational Site

    Herlev, 2730

  • GSK Investigational Site

    Hilleroed, 3400

Other trials in Denmark

Estonia2 sites

  • GSK Investigational Site

    Tallinn, 11619

  • GSK Investigational Site

    Tartu, 51003

Other trials in Estonia

Mexico2 sites

  • GSK Investigational Site

    Durango, Durango, 34079

  • GSK Investigational Site

    Mérida, Yucatán, 97500

Other trials in Mexico

South Korea2 sites

  • GSK Investigational Site

    Seoul, 110-744

  • GSK Investigational Site

    Seoul, 120-752

Other trials in South Korea

Croatia1 site

  • GSK Investigational Site

    Zagreb, 10 000

Other trials in Croatia

India1 site

  • GSK Investigational Site

    Pune, 411001

Other trials in India

Pakistan1 site

  • GSK Investigational Site

    Lahore

Other trials in Pakistan

Poland1 site

  • GSK Investigational Site

    Krakow, 31-115

Other trials in Poland

Thailand1 site

  • GSK Investigational Site

    Bangkok, 10400

Other trials in Thailand

About this study

Official title: A Phase III, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group Study of the Safety and Efficacy of the Intravenous and Oral Formulations of the Neurokinin-1 Receptor Antagonist Casopitant (GW679769) in Combination With Ondansetron and Dexamethasone for the Prevention of Nausea

This is a Phase III trial designed to demonstrate that casopitant (GW679769) plus dexamethasone and ondansetron is more effective in the prevention of vomiting than dexamethasone and ondansetron alone following the administration of moderately emetogenic chemotherapy.

Read the detailed description

A Phase III, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group Study of the Safety and Efficacy of the Intravenous and Oral Formulations of the Neurokinin-1 Receptor Antagonist, Casopitant (GW679769) in Combination with Ondansetron and Dexamethasone for the Prevention of Nausea and Vomiting Induced by Moderately Emetogenic Chemotherapy

Being tested
Casopitant (GW679769) oral tablets, Casopitant (GW679769) intravenous, Dexamethasone intravenous, Ondansetron oral tablets, placebo
Keywords
Anthracycline, Cyclophosphamide, Moderately, Nausea, Emetogenic, Vomiting
Medical subject headings
Vomiting, Nausea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Casopitant (GW679769) oral tabletsDrug

  • Casopitant (GW679769) intravenousDrug

  • Dexamethasone intravenousDrug

  • Ondansetron oral tabletsDrug

    Also called Dexamethasone intravenous, Casopitant (GW679769) oral tablets, Casopitant (GW679769) intravenous

  • placeboDrug

    casopitant placebo

Study groups in NCT00366834
Study groupRoleWhat they receive
ControlPlacebo comparatorondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV on Day 1 + placebo
Receives: Drug: Dexamethasone intravenous; Drug: Ondansetron oral tablets; Drug: placebo
Single dose oralExperimentalondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV + casopitant 150 mg on Day 1
Receives: Drug: Casopitant (GW679769) oral tablets; Drug: Dexamethasone intravenous; Drug: Ondansetron oral tablets
3-day oralExperimentalondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV + casopitant 150 mg on Day 1 + 50 mg on days 2 \& 3
Receives: Drug: Casopitant (GW679769) oral tablets; Drug: Dexamethasone intravenous; Drug: Ondansetron oral tablets
3-day IV/oralExperimentalondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV on Day 1 + 90 mg IV casopitant on day 1 and 50 mg oral casopitant on days 2 \& 3
Receives: Drug: Casopitant (GW679769) oral tablets; Drug: Casopitant (GW679769) intravenous; Drug: Dexamethasone intravenous; Drug: Ondansetron oral tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete response as assessed by a visual analogue scale and a subject diary over the 120 hours following the first cycle of chemotherapy.

    Measured: 120 Hours

Secondary outcomes (18)

  1. Complete response over 120 hours following subsequent chemotherapy cycles Use of rescue medication over 120 hours following all chemotherapy cycles Impact on daily life activities over 120 hours, assessed using a subject diary questionnaire

    Measured: 120 Hours

  2. The proportion of subjects who achieve a complete response during the acute (0-24 hours) and the delayed (24-120 hours) phase following the first cycle of MEC.

    Measured: approx. 18 mos

  3. The proportion of subjects who achieve a complete response over the first 120 hours, during the acute (0-24 hours), the delayed (24-120 hours), and the overall (0-120 hours) phase following subsequent cycles of MEC.

    Measured: approx. 18 mos

  4. Maximum nausea score (to assess the severity of nausea), as assessed by a Visual Analogue Scale (VAS) over the first 120 hours and in the acute and delayed phases following each cycle of MEC.

    Measured: approx. 18 mos

  5. Time to first antiemetic rescue medication, defined as the time elapsed from the start of administration of the MEC regimen to the first use of antiemetic rescue medication.

    Measured: approx. 18 mos

  6. If a subject withdraws prematurely during the first 120 hours, then the time of withdrawal will be considered to be their time to first use of antiemetic rescue medication, and will be censored.

    Measured: approx. 18 mos

  7. Time to first emetic event, defined as the time elapsed from the start of administration of the MEC regimen to the first emetic episode. If a subject withdraws prematurely during the first 120 hours,

    Measured: approx. 18 mos

  8. then the time of withdrawal will be considered to be their time to first emetic episode, and will be censored.

    Measured: approx. 18 mos

  9. The proportion of subjects who receive rescue medication.

    Measured: approx. 18 mos

  10. The proportion of subjects reporting significant nausea defined as a maximum nausea score greater than or equal to 25 mm on the VAS.

    Measured: approx. 18 mos

  11. The proportion of subjects reporting nausea defined as a maximum nausea score greater than or equal to 5 mm on the VAS.

    Measured: approx. 18 mos

  12. The proportion of subjects achieving complete protection, defined as complete responders who had no significant nausea.

    Measured: approx. 18 mos

  13. The impact on subjects' daily life activities for the first 120 hours following the first cycle of chemotherapy as assessed by the FLIE questionnaire.

    Measured: approx. 18 mos

  14. Subject satisfaction with the prophylactic antiemetic regimens, and the willingness of subjects to use the same treatment during future chemotherapy, as assessed by the Subject Satisfaction\Willingness Assessment in the Subject Diary.

    Measured: approx. 18 mos

  15. Nausea as assessed by a categorical scale, over the first 120 hours following MEC administration.

    Measured: approx. 18 mos

  16. Assessment of the safety and tolerability of casopitant through: routine physical exam, routine clinical laboratory tests, clinical monitoring and adverse events reporting.

    Measured: approx. 18 mos

  17. The proportion of subjects who vomit/retch.

    Measured: approx. 18 mos

  18. The proportion of subjects achieving total control, defined as complete responders who had no nausea.

    Measured: approx. 18 mos

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2006 (estimated)
  2. Study startJul 2006
  3. Primary completionOct 2007
  4. Study completionOct 2009

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,840 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00366834
Sponsor's protocol ID
NKV102549
Status last verified
Jun 2012
First submitted
17 Aug 2006
Last updated
10 Sep 2012
Results posted
No
Data monitoring committee
No

Publications

  • Herrstedt J, Apornwirat W, Shaharyar A, Aziz Z, Roila F, Van Belle S, Russo MW, Levin J, Ranganathan S, Guckert M, Grunberg SM. Phase III trial of casopitant, a novel neurokinin-1 receptor antagonist, for the prevention of nausea and vomiting in patients receiving moderately emetogenic chemotherapy. J Clin Oncol. 2009 Nov 10;27(32):5363-9. doi: 10.1200/JCO.2009.21.8511. Epub 2009 Oct 5.

    PubMed 19805683

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Casopitant (GW679769) oral tablets, Casopitant (GW679769) intravenous and Dexamethasone intravenous in people with Vomiting and Nausea, run by GlaxoSmithKline at 223 sites in 32 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 22 inclusion and 28 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 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 223 sites in United States, Canada, Germany, Czechia, Russia and 27 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Complete response as assessed by a visual analogue scale and a subject diary over the 120 hours following the first cycle of chemotherapy. (time frame: 120 Hours). 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 NCT00366834, 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 10 Sep 2012.

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