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

Nausea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00366834
• Other study ID #: NKV102549
• Status: Completed
• Phase: Phase 3
• First received: August 17, 2006
• Last updated: September 6, 2012
• Start date: July 2006
• Est. completion date: October 2009

Study information

• Verified date: June 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1840
• Est. completion date: October 2009
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nausea
• Nausea and Vomiting, Chemotherapy-Induced
• Vomiting

Intervention

Drug:
• Casopitant (GW679769) oral tablets

• Casopitant (GW679769) intravenous

• Dexamethasone intravenous

• Ondansetron oral tablets

• placebo
casopitant placebo

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Capital Federal	Buenos Aires
Argentina	GSK Investigational Site	Mendoza
Argentina	GSK Investigational Site	Quilmes
Argentina	GSK Investigational Site	Rosario	Santa Fe
Argentina	GSK Investigational Site	Tucuman	Tucumán.
Austria	GSK Investigational Site	Salzburg
Austria	GSK Investigational Site	St Poelten
Austria	GSK Investigational Site	Vienna
Austria	GSK Investigational Site	Vienna
Austria	GSK Investigational Site	Vöcklabruck
Belgium	GSK Investigational Site	Brussels
Belgium	GSK Investigational Site	Gent
Belgium	GSK Investigational Site	Ottignies
Bulgaria	GSK Investigational Site	Plovdiv
Bulgaria	GSK Investigational Site	Shumen
Bulgaria	GSK Investigational Site	Sofia
Canada	GSK Investigational Site	Charlottetown	Prince Edward Island
Canada	GSK Investigational Site	Greenfield Park	Quebec
Canada	GSK Investigational Site	Laval	Quebec
Canada	GSK Investigational Site	Levis	Quebec
Canada	GSK Investigational Site	Moncton	New Brunswick
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Oshawa	Ontario
Canada	GSK Investigational Site	Québec	Quebec
Canada	GSK Investigational Site	Saskatoon	Saskatchewan
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	St. John's	Newfoundland and Labrador
Canada	GSK Investigational Site	Thunder Bay	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Vancouver	British Columbia
Canada	GSK Investigational Site	Windsor	Ontario
Croatia	GSK Investigational Site	Zagreb
Czech Republic	GSK Investigational Site	Brno
Czech Republic	GSK Investigational Site	Chomutov
Czech Republic	GSK Investigational Site	Ostrava - Poruba
Czech Republic	GSK Investigational Site	Pardubice
Czech Republic	GSK Investigational Site	Praha 10
Czech Republic	GSK Investigational Site	Tabor
Czech Republic	GSK Investigational Site	Usti nad Labem
Denmark	GSK Investigational Site	Herlev
Denmark	GSK Investigational Site	Hilleroed
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
Germany	GSK Investigational Site	Bad Berka	Thueringen
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Heidelberg	Baden-Wuerttemberg
Germany	GSK Investigational Site	Ingolstadt	Bayern
Germany	GSK Investigational Site	Jena	Thueringen
Germany	GSK Investigational Site	Kassel	Hessen
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Muenchen	Bayern
Germany	GSK Investigational Site	Wuerselen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Wuerzburg	Bayern
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Athens
Greece	GSK Investigational Site	Kavala
Greece	GSK Investigational Site	Patra
Greece	GSK Investigational Site	Thessaloniki
Hong Kong	GSK Investigational Site	Hong Kong
Hong Kong	GSK Investigational Site	Shatin
Hong Kong	GSK Investigational Site	Tuen Mun
Hong Kong	GSK Investigational Site	Wanchai
Hungary	GSK Investigational Site	Gyor
Hungary	GSK Investigational Site	Gyula
Hungary	GSK Investigational Site	Veszprém
India	GSK Investigational Site	Pune
Ireland	GSK Investigational Site	Dublin
Ireland	GSK Investigational Site	Dublin
Ireland	GSK Investigational Site	Dublin
Ireland	GSK Investigational Site	Tallaght, Dublin
Ireland	GSK Investigational Site	Wilton, Cork
Italy	GSK Investigational Site	Benevento	Campania
Italy	GSK Investigational Site	Genova	Liguria
Italy	GSK Investigational Site	Perugia	Umbria
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Sanremo (IM)	Liguria
Italy	GSK Investigational Site	Sassari	Sardegna
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Latvia	GSK Investigational Site	Liepaja
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Lithuania	GSK Investigational Site	Kaunas
Lithuania	GSK Investigational Site	Klaipeda
Lithuania	GSK Investigational Site	Vilnius
Mexico	GSK Investigational Site	Durango
Mexico	GSK Investigational Site	Merida	Yucatán
Pakistan	GSK Investigational Site	Lahore
Peru	GSK Investigational Site	Callao
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	Lima
Philippines	GSK Investigational Site	Cebu
Philippines	GSK Investigational Site	Manila
Philippines	GSK Investigational Site	Quezon City
Philippines	GSK Investigational Site	Sta. Cruz, Manila
Poland	GSK Investigational Site	Krakow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow Region
Russian Federation	GSK Investigational Site	Samara
Russian Federation	GSK Investigational Site	St. Petersburg
Russian Federation	GSK Investigational Site	Yaroslavl
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Bratislava
Slovakia	GSK Investigational Site	Nitra
Slovakia	GSK Investigational Site	Poprad
Slovakia	GSK Investigational Site	Zilina
South Africa	GSK Investigational Site	Athlone Park, Amanzimtoti
South Africa	GSK Investigational Site	Bloemfontein
South Africa	GSK Investigational Site	Observatory
South Africa	GSK Investigational Site	Panorama
South Africa	GSK Investigational Site	Parktown
South Africa	GSK Investigational Site	Saxonwold, Johannesburg
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Ourense
Spain	GSK Investigational Site	San Sebastian
Spain	GSK Investigational Site	Santiago de Compostela
Spain	GSK Investigational Site	Segovia
Spain	GSK Investigational Site	Zamora
Taiwan	GSK Investigational Site	Kaohsiung
Taiwan	GSK Investigational Site	Tainan
Taiwan	GSK Investigational Site	Taipei
Taiwan	GSK Investigational Site	Taipei
Thailand	GSK Investigational Site	Bangkok
United Kingdom	GSK Investigational Site	Aberdeen
United Kingdom	GSK Investigational Site	Chelmsford	Essex
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	London
United Kingdom	GSK Investigational Site	Maidstone
United Kingdom	GSK Investigational Site	Nottingham
United Kingdom	GSK Investigational Site	Shrewsbury
United States	GSK Investigational Site	Akron	Ohio
United States	GSK Investigational Site	Albuquerque	New Mexico
United States	GSK Investigational Site	Alexandria	Louisiana
United States	GSK Investigational Site	Augusta	Georgia
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Baton Rouge	Louisiana
United States	GSK Investigational Site	Bethlehem	Pennsylvania
United States	GSK Investigational Site	Billings	Montana
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Birmingham	Alabama
United States	GSK Investigational Site	Bismarck	North Dakota
United States	GSK Investigational Site	Boynton Beach	Florida
United States	GSK Investigational Site	Brooksville	Florida
United States	GSK Investigational Site	Buffalo	New York
United States	GSK Investigational Site	Burlington	Vermont
United States	GSK Investigational Site	Centralia	Illinois
United States	GSK Investigational Site	Clinton Township	Michigan
United States	GSK Investigational Site	Columbus	Georgia
United States	GSK Investigational Site	Concord	California
United States	GSK Investigational Site	Corpus Christi	Texas
United States	GSK Investigational Site	Corpus Christi	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Denville	New Jersey
United States	GSK Investigational Site	Durham	North Carolina
United States	GSK Investigational Site	Evansville	Indiana
United States	GSK Investigational Site	Everett	Washington
United States	GSK Investigational Site	Fayetteville	Arkansas
United States	GSK Investigational Site	Fort Lauderdale	Florida
United States	GSK Investigational Site	Fort Lauderdale	Florida
United States	GSK Investigational Site	Fountain Valley	California
United States	GSK Investigational Site	Free Soil	Michigan
United States	GSK Investigational Site	Fresno	California
United States	GSK Investigational Site	Galesburg	Illinois
United States	GSK Investigational Site	Glendale	Arizona
United States	GSK Investigational Site	Great Falls	Montana
United States	GSK Investigational Site	Greenbrae	California
United States	GSK Investigational Site	Hattiesburg	Mississippi
United States	GSK Investigational Site	Hazard	Kentucky
United States	GSK Investigational Site	Hershey	Pennsylvania
United States	GSK Investigational Site	Hot Springs	Arkansas
United States	GSK Investigational Site	Huntington	West Virginia
United States	GSK Investigational Site	Huntington	West Virginia
United States	GSK Investigational Site	Inverness	Florida
United States	GSK Investigational Site	Jefferson City	Missouri
United States	GSK Investigational Site	Jonesboro	Arkansas
United States	GSK Investigational Site	La Verne	California
United States	GSK Investigational Site	Lawrenceville	Georgia
United States	GSK Investigational Site	Lexington	Kentucky
United States	GSK Investigational Site	Logan	Utah
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Madison	Wisconsin
United States	GSK Investigational Site	Mason City	Iowa
United States	GSK Investigational Site	Metairie	Louisiana
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Mt. Pleasant	South Carolina
United States	GSK Investigational Site	Muncie	Indiana
United States	GSK Investigational Site	New Port Richey	Florida
United States	GSK Investigational Site	Newark	New Jersey
United States	GSK Investigational Site	Norwich	Connecticut
United States	GSK Investigational Site	Ogden	Utah
United States	GSK Investigational Site	Orange	California
United States	GSK Investigational Site	Pittsfield	Massachusetts
United States	GSK Investigational Site	Poway	California
United States	GSK Investigational Site	Richardson	Texas
United States	GSK Investigational Site	Rolla	Missouri
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	Sayre	Pennsylvania
United States	GSK Investigational Site	Skokie	Illinois
United States	GSK Investigational Site	Somerville	New Jersey
United States	GSK Investigational Site	Soquel	California
United States	GSK Investigational Site	Sparta	New Jersey
United States	GSK Investigational Site	Spokane	Washington
United States	GSK Investigational Site	St. Joseph	Michigan
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	Sumter	South Carolina
United States	GSK Investigational Site	Tacoma	Washington
United States	GSK Investigational Site	Tamarac	Florida
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Terre Haute	Indiana
United States	GSK Investigational Site	Troy	Michigan
United States	GSK Investigational Site	Tupelo	Mississippi
United States	GSK Investigational Site	Washington	District of Columbia
United States	GSK Investigational Site	West Palm Beach	Florida
United States	GSK Investigational Site	Winston-Salem	North Carolina
United States	GSK Investigational Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Bulgaria,  Canada,  Croatia,  Czech Republic,  Denmark,  Estonia,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Ireland,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  Pakistan,  Peru,  Philippines,  Poland,  Russian Federation,  Slovakia,  South Africa,  Spain,  Taiwan,  Thailand,  United Kingdom, 

References & Publications (1)

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 — View Citation

Outcome

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