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

September 6, 2012 updated by: GlaxoSmithKline

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

1840

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Mendoza, Argentina, M5500AYB
        • GSK Investigational Site
      • Quilmes, Argentina, 1878
        • GSK Investigational Site
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, C1405CUB
        • GSK Investigational Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000KZE
        • GSK Investigational Site
    • Tucumán.
      • Tucuman, Tucumán., Argentina, 4000
        • GSK Investigational Site
  • Austria
      • Salzburg, Austria, A-5020
        • GSK Investigational Site
      • St Poelten, Austria, A-3100
        • GSK Investigational Site
      • Vienna, Austria, A-1090
        • GSK Investigational Site
      • Vienna, Austria, A-1130
        • GSK Investigational Site
      • Vöcklabruck, Austria, A-4840
        • GSK Investigational Site
  • Belgium
      • Brussels, Belgium, 1070
        • GSK Investigational Site
      • Gent, Belgium, 9000
        • GSK Investigational Site
      • Ottignies, Belgium, 1340
        • GSK Investigational Site
  • Bulgaria
      • Plovdiv, Bulgaria, 4000
        • GSK Investigational Site
      • Shumen, Bulgaria, 9700
        • GSK Investigational Site
      • Sofia, Bulgaria, 1527
        • GSK Investigational Site
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • GSK Investigational Site
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 8X3
        • GSK Investigational Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • GSK Investigational Site
    • Ontario
      • Oshawa, Ontario, Canada, L1G 2B9
        • GSK Investigational Site
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M5G 1X5
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M5G2M9
        • GSK Investigational Site
      • Windsor, Ontario, Canada, N8W 2X3
        • GSK Investigational Site
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada, C1A 8T5
        • GSK Investigational Site
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • GSK Investigational Site
      • Laval, Quebec, Canada, H7M 3L9
        • GSK Investigational Site
      • Levis, Quebec, Canada, G6V 3Z1
        • GSK Investigational Site
      • Montreal, Quebec, Canada, H1T 2M4
        • GSK Investigational Site
      • Québec, Quebec, Canada, G1J 1Z4
        • GSK Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • GSK Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • GSK Investigational Site
  • Croatia
      • Zagreb, Croatia, 10 000
        • GSK Investigational Site
  • Czech Republic
      • Brno, Czech Republic, 656 53
        • GSK Investigational Site
      • Chomutov, Czech Republic, 43012
        • GSK Investigational Site
      • Ostrava - Poruba, Czech Republic, 708 52
        • GSK Investigational Site
      • Pardubice, Czech Republic, 532 03
        • GSK Investigational Site
      • Praha 10, Czech Republic, 100 00
        • GSK Investigational Site
      • Tabor, Czech Republic, 390 19
        • GSK Investigational Site
      • Usti nad Labem, Czech Republic, 40113
        • GSK Investigational Site
  • Denmark
      • Herlev, Denmark, 2730
        • GSK Investigational Site
      • Hilleroed, Denmark, 3400
        • GSK Investigational Site
  • Estonia
      • Tallinn, Estonia, 11619
        • GSK Investigational Site
      • Tartu, Estonia, 51003
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 10367
        • GSK Investigational Site
      • Berlin, Germany, 12163
        • GSK Investigational Site
      • Hamburg, Germany, 20357
        • GSK Investigational Site
      • Hamburg, Germany, 22457
        • GSK Investigational Site
      • Hamburg, Germany, 22081
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Heidelberg, Baden-Wuerttemberg, Germany, 69126
        • GSK Investigational Site
    • Bayern
      • Ingolstadt, Bayern, Germany, 85049
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 80335
        • GSK Investigational Site
      • Muenchen, Bayern, Germany, 81925
        • GSK Investigational Site
      • Wuerzburg, Bayern, Germany, 97070
        • GSK Investigational Site
    • Hessen
      • Kassel, Hessen, Germany, 34119
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Wuerselen, Nordrhein-Westfalen, Germany, 52146
        • GSK Investigational Site
    • Thueringen
      • Bad Berka, Thueringen, Germany, 99437
        • GSK Investigational Site
      • Jena, Thueringen, Germany, 07743
        • GSK Investigational Site
  • Greece
      • Athens, Greece, 115 22
        • GSK Investigational Site
      • Athens, Greece, 115 28
        • GSK Investigational Site
      • Kavala, Greece, 65403
        • GSK Investigational Site
      • Patra, Greece, 26500
        • GSK Investigational Site
      • Thessaloniki, Greece, 54636
        • GSK Investigational Site
  • Hong Kong
      • Hong Kong, Hong Kong
        • GSK Investigational Site
      • Shatin, Hong Kong
        • GSK Investigational Site
      • Tuen Mun, Hong Kong
        • GSK Investigational Site
      • Wanchai, Hong Kong
        • GSK Investigational Site
  • Hungary
      • Gyula, Hungary, 5700
        • GSK Investigational Site
      • Győr, Hungary, 9023
        • GSK Investigational Site
      • Veszprém, Hungary, 8200
        • GSK Investigational Site
  • India
      • Pune, India, 411001
        • GSK Investigational Site
  • Ireland
      • Dublin, Ireland, 8
        • GSK Investigational Site
      • Dublin, Ireland, 9
        • GSK Investigational Site
      • Dublin, Ireland, 4
        • GSK Investigational Site
      • Tallaght, Dublin, Ireland, 24
        • GSK Investigational Site
      • Wilton, Cork, Ireland
        • GSK Investigational Site
  • Italy
    • Campania
      • Benevento, Campania, Italy, 82100
        • GSK Investigational Site
    • Lazio
      • Roma, Lazio, Italy, 00184
        • GSK Investigational Site
    • Liguria
      • Genova, Liguria, Italy, 16132
        • GSK Investigational Site
      • Sanremo (IM), Liguria, Italy, 18038
        • GSK Investigational Site
    • Sardegna
      • Sassari, Sardegna, Italy, 07100
        • GSK Investigational Site
    • Umbria
      • Perugia, Umbria, Italy, 06156
        • GSK Investigational Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 110-744
        • GSK Investigational Site
  • Latvia
      • Liepaja, Latvia, LV3401
        • GSK Investigational Site
      • Riga, Latvia, LV 1002
        • GSK Investigational Site
      • Riga, Latvia, LV 1079
        • GSK Investigational Site
  • Lithuania
      • Kaunas, Lithuania, LT-45434
        • GSK Investigational Site
      • Klaipeda, Lithuania, LT-92228
        • GSK Investigational Site
      • Vilnius, Lithuania, LT-08660
        • GSK Investigational Site
  • Mexico
      • Durango, Mexico, 34079
        • GSK Investigational Site
    • Yucatán
      • Merida, Yucatán, Mexico, 97500
        • GSK Investigational Site
  • Pakistan
      • Lahore, Pakistan
        • GSK Investigational Site
  • Peru
      • Callao, Peru, Callao 2
        • GSK Investigational Site
      • Lima, Peru, Lima 34
        • GSK Investigational Site
      • Lima, Peru, Lima 13
        • GSK Investigational Site
  • Philippines
      • Cebu, Philippines, 6000
        • GSK Investigational Site
      • Manila, Philippines, 1000
        • GSK Investigational Site
      • Quezon City, Philippines, 1100
        • GSK Investigational Site
      • Sta. Cruz, Manila, Philippines, 1012
        • GSK Investigational Site
  • Poland
      • Krakow, Poland, 31-115
        • GSK Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 117997
        • GSK Investigational Site
      • Moscow, Russian Federation, 115478
        • GSK Investigational Site
      • Moscow, Russian Federation, 115 478
        • GSK Investigational Site
      • Moscow Region, Russian Federation, 143 423
        • GSK Investigational Site
      • Samara, Russian Federation, 443066
        • GSK Investigational Site
      • St. Petersburg, Russian Federation, 198255
        • GSK Investigational Site
      • Yaroslavl, Russian Federation, 150054
        • GSK Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 833 10
        • GSK Investigational Site
      • Bratislava, Slovakia, 812 50
        • GSK Investigational Site
      • Nitra, Slovakia, 949 01
        • GSK Investigational Site
      • Poprad, Slovakia, 058 01
        • GSK Investigational Site
      • Zilina, Slovakia, 010 01
        • GSK Investigational Site
  • South Africa
      • Athlone Park, Amanzimtoti, South Africa, 4126
        • GSK Investigational Site
      • Bloemfontein, South Africa, 9301
        • GSK Investigational Site
      • Observatory, South Africa, 7925
        • GSK Investigational Site
      • Panorama, South Africa, 7500
        • GSK Investigational Site
      • Parktown, South Africa, 2193
        • GSK Investigational Site
      • Saxonwold, Johannesburg, South Africa, 2196
        • GSK Investigational Site
  • Spain
      • Madrid, Spain, 28034
        • GSK Investigational Site
      • Ourense, Spain, 32005
        • GSK Investigational Site
      • San Sebastian, Spain, 20012
        • GSK Investigational Site
      • Santiago de Compostela, Spain, 15706
        • GSK Investigational Site
      • Segovia, Spain, 40002
        • GSK Investigational Site
      • Zamora, Spain
        • GSK Investigational Site
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • GSK Investigational Site
      • Tainan, Taiwan, 704
        • GSK Investigational Site
      • Taipei, Taiwan
        • GSK Investigational Site
      • Taipei, Taiwan, 114
        • GSK Investigational Site
  • Thailand
      • Bangkok, Thailand, 10400
        • GSK Investigational Site
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • GSK Investigational Site
      • London, United Kingdom, SE1 9RT
        • GSK Investigational Site
      • London, United Kingdom, EC1A 7BE
        • GSK Investigational Site
      • Maidstone, United Kingdom, ME16 9QQ
        • GSK Investigational Site
      • Nottingham, United Kingdom, NG5 1PB
        • GSK Investigational Site
      • Shrewsbury, United Kingdom, SY3 8XQ
        • GSK Investigational Site
    • Essex
      • Chelmsford, Essex, United Kingdom, CM1 7ET
        • GSK Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • GSK Investigational Site
      • Birmingham, Alabama, United States, 35233
        • GSK Investigational Site
    • Arizona
      • Glendale, Arizona, United States, 85304
        • GSK Investigational Site
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • GSK Investigational Site
      • Hot Springs, Arkansas, United States, 71913
        • GSK Investigational Site
      • Jonesboro, Arkansas, United States, 72401
        • GSK Investigational Site
    • California
      • Concord, California, United States, 94520
        • GSK Investigational Site
      • Fountain Valley, California, United States, 92708
        • GSK Investigational Site
      • Fresno, California, United States, 93710
        • GSK Investigational Site
      • Greenbrae, California, United States, 94904-2007
        • GSK Investigational Site
      • La Verne, California, United States, 91750
        • GSK Investigational Site
      • Los Angeles, California, United States, 90057
        • GSK Investigational Site
      • Orange, California, United States, 92868
        • GSK Investigational Site
      • Poway, California, United States, 92064
        • GSK Investigational Site
      • San Diego, California, United States, 92121
        • GSK Investigational Site
      • Soquel, California, United States, 95073
        • GSK Investigational Site
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • GSK Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • GSK Investigational Site
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • GSK Investigational Site
      • Brooksville, Florida, United States, 34613
        • GSK Investigational Site
      • Fort Lauderdale, Florida, United States, 33316
        • GSK Investigational Site
      • Fort Lauderdale, Florida, United States, 33328
        • GSK Investigational Site
      • Inverness, Florida, United States, 34452
        • GSK Investigational Site
      • Miami, Florida, United States, 33179
        • GSK Investigational Site
      • New Port Richey, Florida, United States, 34652
        • GSK Investigational Site
      • Tamarac, Florida, United States, 33321
        • GSK Investigational Site
      • Tampa, Florida, United States, 33614
        • GSK Investigational Site
      • West Palm Beach, Florida, United States, 33401
        • GSK Investigational Site
    • Georgia
      • Augusta, Georgia, United States, 30912
        • GSK Investigational Site
      • Columbus, Georgia, United States, 31904
        • GSK Investigational Site
      • Lawrenceville, Georgia, United States, 30045
        • GSK Investigational Site
    • Illinois
      • Centralia, Illinois, United States, 62801
        • GSK Investigational Site
      • Galesburg, Illinois, United States, 61401
        • GSK Investigational Site
      • Skokie, Illinois, United States, 60076
        • GSK Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47713
        • GSK Investigational Site
      • Muncie, Indiana, United States, 47303
        • GSK Investigational Site
      • Terre Haute, Indiana, United States, 47804
        • GSK Investigational Site
    • Iowa
      • Mason City, Iowa, United States, 50401
        • GSK Investigational Site
    • Kentucky
      • Hazard, Kentucky, United States, 41701
        • GSK Investigational Site
      • Lexington, Kentucky, United States, 40503
        • GSK Investigational Site
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • GSK Investigational Site
      • Baton Rouge, Louisiana, United States, 70809
        • GSK Investigational Site
      • Metairie, Louisiana, United States, 70006
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • GSK Investigational Site
      • Baltimore, Maryland, United States, 21229-5299
        • GSK Investigational Site
    • Massachusetts
      • Pittsfield, Massachusetts, United States, 01201
        • GSK Investigational Site
      • Worcester, Massachusetts, United States, 01608
        • GSK Investigational Site
    • Michigan
      • Clinton Township, Michigan, United States, 48038
        • GSK Investigational Site
      • Free Soil, Michigan, United States, 49411
        • GSK Investigational Site
      • St. Joseph, Michigan, United States, 49085
        • GSK Investigational Site
      • Troy, Michigan, United States, 48085
        • GSK Investigational Site
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • GSK Investigational Site
      • Tupelo, Mississippi, United States, 38801
        • GSK Investigational Site
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • GSK Investigational Site
      • Rolla, Missouri, United States, 65401
        • GSK Investigational Site
      • St. Louis, Missouri, United States, 63141
        • GSK Investigational Site
    • Montana
      • Billings, Montana, United States, 59101
        • GSK Investigational Site
      • Great Falls, Montana, United States, 59405
        • GSK Investigational Site
    • New Jersey
      • Denville, New Jersey, United States, 07834
        • GSK Investigational Site
      • Newark, New Jersey, United States, 07112
        • GSK Investigational Site
      • Somerville, New Jersey, United States, 08876
        • GSK Investigational Site
      • Sparta, New Jersey, United States, 07871
        • GSK Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • GSK Investigational Site
    • New York
      • Buffalo, New York, United States, 14215
        • GSK Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • GSK Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • GSK Investigational Site
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • GSK Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44304
        • GSK Investigational Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • GSK Investigational Site
      • Hershey, Pennsylvania, United States, 17033
        • GSK Investigational Site
      • Sayre, Pennsylvania, United States, 18840
        • GSK Investigational Site
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464
        • GSK Investigational Site
      • Sumter, South Carolina, United States, 29150
        • GSK Investigational Site
    • Texas
      • Corpus Christi, Texas, United States, 78412
        • GSK Investigational Site
      • Corpus Christi, Texas, United States, 78463-3069
        • GSK Investigational Site
      • Dallas, Texas, United States, 75237
        • GSK Investigational Site
      • Richardson, Texas, United States, 75080
        • GSK Investigational Site
    • Utah
      • Logan, Utah, United States, 84341
        • GSK Investigational Site
      • Ogden, Utah, United States, 84403
        • GSK Investigational Site
    • Vermont
      • Burlington, Vermont, United States, 05401
        • GSK Investigational Site
    • Washington
      • Everett, Washington, United States, 98201
        • GSK Investigational Site
      • Spokane, Washington, United States, 99204
        • GSK Investigational Site
      • Tacoma, Washington, United States, 98405
        • GSK Investigational Site
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • GSK Investigational Site
      • Huntington, West Virginia, United States, 25705
        • GSK Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53717
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • 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:

    • 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:

    1. 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)

    2. 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.

Exclusion criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Control
ondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV on Day 1 + placebo
Drug: Dexamethasone intravenous
Drug: Ondansetron oral tablets
Other Names:
  • Dexamethasone intravenous
  • Casopitant (GW679769) oral tablets
  • Casopitant (GW679769) intravenous
Drug: placebo
casopitant placebo
EXPERIMENTAL: Single dose oral
ondansetron 8 mg oral twice daily on Day 1-3 and dexamethasone 8 mg IV + casopitant 150 mg on Day 1
Drug: Dexamethasone intravenous
Drug: Ondansetron oral tablets
Other Names:
  • Dexamethasone intravenous
  • Casopitant (GW679769) oral tablets
  • Casopitant (GW679769) intravenous
Drug: Casopitant (GW679769) oral tablets
EXPERIMENTAL: 3-day oral
ondansetron 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
Drug: Dexamethasone intravenous
Drug: Ondansetron oral tablets
Other Names:
  • Dexamethasone intravenous
  • Casopitant (GW679769) oral tablets
  • Casopitant (GW679769) intravenous
Drug: Casopitant (GW679769) oral tablets
EXPERIMENTAL: 3-day IV/oral
ondansetron 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
Drug: Dexamethasone intravenous
Drug: Ondansetron oral tablets
Other Names:
  • Dexamethasone intravenous
  • Casopitant (GW679769) oral tablets
  • Casopitant (GW679769) intravenous
Drug: Casopitant (GW679769) oral tablets
Drug: Casopitant (GW679769) intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
120 Hours

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 120 Hours
120 Hours
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.
Time Frame: approx. 18 mos
approx. 18 mos
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.
Time Frame: approx. 18 mos
approx. 18 mos
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.
Time Frame: approx. 18 mos
approx. 18 mos
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.
Time Frame: approx. 18 mos
approx. 18 mos
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.
Time Frame: approx. 18 mos
approx. 18 mos
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,
Time Frame: approx. 18 mos
approx. 18 mos
then the time of withdrawal will be considered to be their time to first emetic episode, and will be censored.
Time Frame: approx. 18 mos
approx. 18 mos
The proportion of subjects who receive rescue medication.
Time Frame: approx. 18 mos
approx. 18 mos
The proportion of subjects reporting significant nausea defined as a maximum nausea score greater than or equal to 25 mm on the VAS.
Time Frame: approx. 18 mos
approx. 18 mos
The proportion of subjects reporting nausea defined as a maximum nausea score greater than or equal to 5 mm on the VAS.
Time Frame: approx. 18 mos
approx. 18 mos
The proportion of subjects achieving complete protection, defined as complete responders who had no significant nausea.
Time Frame: approx. 18 mos
approx. 18 mos
The impact on subjects' daily life activities for the first 120 hours following the first cycle of chemotherapy as assessed by the FLIE questionnaire.
Time Frame: approx. 18 mos
approx. 18 mos
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.
Time Frame: approx. 18 mos
approx. 18 mos
Nausea as assessed by a categorical scale, over the first 120 hours following MEC administration.
Time Frame: approx. 18 mos
approx. 18 mos
Assessment of the safety and tolerability of casopitant through: routine physical exam, routine clinical laboratory tests, clinical monitoring and adverse events reporting.
Time Frame: approx. 18 mos
approx. 18 mos
The proportion of subjects who vomit/retch.
Time Frame: approx. 18 mos
approx. 18 mos
The proportion of subjects achieving total control, defined as complete responders who had no nausea.
Time Frame: approx. 18 mos
approx. 18 mos

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (ACTUAL)

October 1, 2007

Study Completion (ACTUAL)

October 1, 2009

Study Registration Dates

First Submitted

August 17, 2006

First Submitted That Met QC Criteria

August 17, 2006

First Posted (ESTIMATE)

August 21, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

September 10, 2012

Last Update Submitted That Met QC Criteria

September 6, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NKV102549

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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