A Study of the Drug Casopitant for the Prevention of Nausea Caused By Cisplatin-Based Highly Emetogenic Chemotherapy
NCT ID: NCT00431236
Last Updated: 2017-08-22
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
810 participants
Study Classification
INTERVENTIONAL
Study Start Date
2006-11-06
Study Completion Date
2007-10-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This is a Phase III trial designed to demonstrate that casopitant when added to dexamethasone and ondansetron is more effective in the prevention of vomiting then dexamethasone and ondansetron alone, in patients who receive a cisplatin-based highly emetogenic chemotherapy.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Intravenous And Oral Casopitant (GW679769) For The Prevention Of Chemotherapy Induced Nausea And Vomiting
NCT00366834
Vomiting
Nausea
Nausea and Vomiting, Chemotherapy-Induced
COMPLETED
PHASE3
A Study Of IV Casopitant For The Prevention Of Chemotherapy Induced Nausea And Vomiting.
NCT00601172
Nausea and Vomiting, Chemotherapy-Induced
COMPLETED
PHASE3
A Study of IV Casopitant for the Prevention of Nausea and Vomiting Caused By Cisplatin-Based Highly Emetogenic Chemotherapy
NCT00891761
Cancer
Chemotherapy-Induced Nausea and Vomiting
Nausea and Vomiting
+1 more
WITHDRAWN
PHASE3
Study for The Prevention Of Nausea in Cancer Patients Receiving Highly Emetogenic Cisplatin Based Chemotherapy
NCT00169572
Nausea and Vomiting
Chemotherapy-Induced
COMPLETED
PHASE2
Palonosetron, Ondansetron, and Dexamethasone for Delayed Nausea and Vomiting in Autologous Transplant Patients
NCT01370408
Chemotherapy-induced Nausea and Vomiting
COMPLETED
PHASE2
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
A Phase III Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group Study of the Efficacy and Safety of the Intravenous and Oral Formulations of the Neurokinin-1 Receptor Antagonist, Casopitant, administered in Combination with ZOFRAN and Dexamethasone for Prevention of Chemotherapy-Induced Nausea and Vomiting in Cancer Subjects Receiving Highly Emetogenic Cisplatin-Based Chemotherapy
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Nausea and Vomiting, Chemotherapy-Induced
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Oral Casopitant (GW679769)
Intervention Type
DRUG
IV Casopitant (GW679769)
Intervention Type
DRUG
IV ondansetron hydrochloride
Intervention Type
DRUG
Oral dexamethasone
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
IV ondansetron hydrochloride
IV Casopitant (GW679769)
Oral Casopitant (GW679769)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* Males or females of at least 18 years of age.
* Diagnosed with a malignant solid tumor and is scheduled to receive their first course of cytotoxic chemotherapy with cisplatin administered as a single intravenous dose of ≥ 70mg/m² over 1-4 hours on study Day 1, either alone or in combination with other chemotherapeutic agents. For combination regimens, non-cisplatin agents of moderate to high emetogenic potential will be allowed, but must be administered following the cisplatin infusion and be completed no more than 6 hours after the initiation of the cisplatin infusion. Chemotherapy agents of minimal to low emetogenic potential may be given on Day 1 following cisplatin or on any subsequent study day. Taxanes (e.g. paclitaxel, docetaxel) may be administered on study Day 1 only following cisplatin.
* Has an ECOG Performance Status of 0, 1, or 2.
* Hematologic and metabolic status must be adequate for receiving a highly emetogenic cisplatin-based regimen and meet the following criteria:
* Total Neutrophils ≥ 1500/mm³ (Standard units : ≥1.5 x 10\^9/L)
* Platelets ≥ 100,000/mm (Standard units: ≥100.0 x 10\^9/L)
* Bilirubin ≤ 1.5 x ULN
* Serum Creatinine ≤1.5 mg/dL (Standard units : ≤ 132.6 µMOL/L OR
* Creatinine clearance ≥ 60 mL/min
Creatinine clearance must be calculated using the Cockcroft-Gault formula:
Clcreat (ml/min) = (140-age \[yr\]) x body wt \[kg\] 72 x serum creatinine \[mg/dl\] For females: multiply creatinine clearance by a factor of 0.85. OR Clcreat (ml/min) = (140-age \[yr\]) x body wt \[kg\] serum creatinine \[µmol/L\] K=1.05 for females K=1.23 for males
* 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 a 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.
obstruction
* Males or females of at least 18 years of age.
* Diagnosed with a malignant solid tumor and is scheduled to receive their first course of cytotoxic chemotherapy with cisplatin administered as a single intravenous dose of ≥ 70mg/m² over 1-4 hours on study Day 1, either alone or in combination with other chemotherapeutic agents. For combination regimens, non-cisplatin agents of moderate to high emetogenic potential will be allowed, but must be administered following the cisplatin infusion and be completed no more than 6 hours after the initiation of the cisplatin infusion. Chemotherapy agents of minimal to low emetogenic potential may be given on Day 1 following cisplatin or on any subsequent study day. Taxanes (e.g. paclitaxel, docetaxel) may be administered on study Day 1 only following cisplatin.
* Has an ECOG Performance Status of 0, 1, or 2.
* Hematologic and metabolic status must be adequate for receiving a highly emetogenic cisplatin-based regimen and meet the following criteria:
* Total Neutrophils ≥ 1500/mm³ (Standard units : ≥1.5 x 10\^9/L)
* Platelets ≥ 100,000/mm (Standard units: ≥100.0 x 10\^9/L)
* Bilirubin ≤ 1.5 x ULN
* Serum Creatinine ≤1.5 mg/dL (Standard units : ≤ 132.6 µMOL/L OR
* Creatinine clearance ≥ 60 mL/min
Creatinine clearance must be calculated using the Cockcroft-Gault formula:
Clcreat (ml/min) = (140-age \[yr\]) x body wt \[kg\] 72 x serum creatinine \[mg/dl\] For females: multiply creatinine clearance by a factor of 0.85. OR Clcreat (ml/min) = (140-age \[yr\]) x body wt \[kg\] serum creatinine \[µmol/L\] K=1.05 for females K=1.23 for males
* 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 a 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.
obstruction
Exclusion Criteria
* Has previously received cytotoxic chemotherapy. Previous biological or hormonal therapy will be permitted.
* Is scheduled to receive cisplatin treatment on more than one day during a single cycle of therapy.
* If female, is pregnant or lactating.
* Has received radiation therapy to the thorax, head \& neck, abdomen, or the pelvis in the 10 days prior to receiving the first dose of study medication and/or will receive radiation therapy to the thorax, head \& neck, abdomen or the pelvis in the 6 days following the first dose of study medication.
* Emesis (i.e. vomiting and/or retching) experienced in the 24 hours prior to receiving the first dose of study medication.
* Clinically significant nausea (e.g. ≥25 mm on a VAS) in the 24 hours prior to receiving the first dose of study medication.
* A known central nervous system primary or malignancy metastatic to the CNS, unless successfully treated with excision or radiation and subsequently has been stable for at least 1 week prior to receiving the first dose of study medication.
* 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.
* An active systemic infection or any uncontrolled disease (other than malignancy) which, in the opinion of the investigator, may confound the results of the study or pose an unwarranted risk to the subject. Subjects with a previous, but not current, history of alcoholism may be permitted provided that, in the investigator's opinion, the subject's disease state will not confound the results of the study.
* Receiving or planning to receive a systemic corticosteroid therapy at any dose within 72 hours prior to the first dose of study medication, except where indicated as premedication for a taxane. However, topical steroids and inhaled corticosteroids with a steroid dose of≤10 mg prednisone daily or its equivalent are permitted.
* Is scheduled to receive bone marrow transplantation and/or stem cell rescue with this course of cisplatin therapy.
* Has received an investigational drug within the 30 days or five half-lives (whichever is longer) prior to receiving the first dose of study medication, and/or is scheduled to receive any investigational drug during the study.
* Has received moderately and/or highly emetogenic medication within the 48 hours prior to the first dose of study medication. (Opioid narcotics for cancer pain will be permitted if the subject has been on such medication for at least 7 days and has not experienced nausea or emesis 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 GW679769 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 or pemetrexed therapy)
* 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
* domperidone
* mirtazapine
* olanzapine
* cannabinoids
* Has taken/received strong or moderate inhibitors of CYP3A4 and CYP3A5 prior to administration of casopitant (GW679769) investigational product
* Has taken/received inducers of CYP3A4 and CYP3A5 within fourteen days prior to the administration of casopitant investigational product
* 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
* Is currently taking or plans to take any of the following CYP3A4 substrates: astemizole, cisapride, pimozide, terfenadine.
* Is scheduled to receive cisplatin treatment on more than one day during a single cycle of therapy.
* If female, is pregnant or lactating.
* Has received radiation therapy to the thorax, head \& neck, abdomen, or the pelvis in the 10 days prior to receiving the first dose of study medication and/or will receive radiation therapy to the thorax, head \& neck, abdomen or the pelvis in the 6 days following the first dose of study medication.
* Emesis (i.e. vomiting and/or retching) experienced in the 24 hours prior to receiving the first dose of study medication.
* Clinically significant nausea (e.g. ≥25 mm on a VAS) in the 24 hours prior to receiving the first dose of study medication.
* A known central nervous system primary or malignancy metastatic to the CNS, unless successfully treated with excision or radiation and subsequently has been stable for at least 1 week prior to receiving the first dose of study medication.
* 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.
* An active systemic infection or any uncontrolled disease (other than malignancy) which, in the opinion of the investigator, may confound the results of the study or pose an unwarranted risk to the subject. Subjects with a previous, but not current, history of alcoholism may be permitted provided that, in the investigator's opinion, the subject's disease state will not confound the results of the study.
* Receiving or planning to receive a systemic corticosteroid therapy at any dose within 72 hours prior to the first dose of study medication, except where indicated as premedication for a taxane. However, topical steroids and inhaled corticosteroids with a steroid dose of≤10 mg prednisone daily or its equivalent are permitted.
* Is scheduled to receive bone marrow transplantation and/or stem cell rescue with this course of cisplatin therapy.
* Has received an investigational drug within the 30 days or five half-lives (whichever is longer) prior to receiving the first dose of study medication, and/or is scheduled to receive any investigational drug during the study.
* Has received moderately and/or highly emetogenic medication within the 48 hours prior to the first dose of study medication. (Opioid narcotics for cancer pain will be permitted if the subject has been on such medication for at least 7 days and has not experienced nausea or emesis 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 GW679769 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 or pemetrexed therapy)
* 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
* domperidone
* mirtazapine
* olanzapine
* cannabinoids
* Has taken/received strong or moderate inhibitors of CYP3A4 and CYP3A5 prior to administration of casopitant (GW679769) investigational product
* Has taken/received inducers of CYP3A4 and CYP3A5 within fourteen days prior to the administration of casopitant investigational product
* 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
* Is currently taking or plans to take any of the following CYP3A4 substrates: astemizole, cisapride, pimozide, terfenadine.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
GSK Investigational Site
Capital Federal, Buenos Aires, Argentina
Site Status
GSK Investigational Site
Córdoba, Córdoba Province, Argentina
Site Status
GSK Investigational Site
Rosario, Santa Fe Province, Argentina
Site Status
GSK Investigational Site
San Miguel de Tucumán, , Argentina
Site Status
GSK Investigational Site
Edegem, , Belgium
Site Status
GSK Investigational Site
Leuven, , Belgium
Site Status
GSK Investigational Site
Liège, , Belgium
Site Status
GSK Investigational Site
Sofia, , Bulgaria
Site Status
GSK Investigational Site
Varna, , Bulgaria
Site Status
GSK Investigational Site
Zagreb, , Croatia
Site Status
GSK Investigational Site
Zagreb, , Croatia
Site Status
GSK Investigational Site
Zagreb, , Croatia
Site Status
GSK Investigational Site
Brno, , Czechia
Site Status
GSK Investigational Site
Brno, , Czechia
Site Status
GSK Investigational Site
Jihlava, , Czechia
Site Status
GSK Investigational Site
Ostrava, , Czechia
Site Status
GSK Investigational Site
Prague, , Czechia
Site Status
GSK Investigational Site
Tábor, , Czechia
Site Status
GSK Investigational Site
Helsinki, , Finland
Site Status
GSK Investigational Site
Kangasala, , Finland
Site Status
GSK Investigational Site
Turku, , Finland
Site Status
GSK Investigational Site
Athens, , Greece
Site Status
GSK Investigational Site
Kavala, , Greece
Site Status
GSK Investigational Site
Papagos, Athens, , Greece
Site Status
GSK Investigational Site
Thessaloniki, , Greece
Site Status
GSK Investigational Site
Thessaloniki, , Greece
Site Status
GSK Investigational Site
Budapest, , Hungary
Site Status
GSK Investigational Site
Mátraháza, , Hungary
Site Status
GSK Investigational Site
Székesfehérvár, , Hungary
Site Status
GSK Investigational Site
Kochi, , India
Site Status
GSK Investigational Site
Tirupati, , India
Site Status
GSK Investigational Site
Dublin, , Ireland
Site Status
GSK Investigational Site
Tallaght, Dublin, , Ireland
Site Status
GSK Investigational Site
Wilton, Cork, , Ireland
Site Status
GSK Investigational Site
Monteforte Irpino, Campania, Italy
Site Status
GSK Investigational Site
Rome, Lazio, Italy
Site Status
GSK Investigational Site
Rome, Lazio, Italy
Site Status
GSK Investigational Site
Sassari, Sardinia, Italy
Site Status
GSK Investigational Site
Pisa, Tuscany, Italy
Site Status
GSK Investigational Site
George Town, , Malaysia
Site Status
GSK Investigational Site
Kubang Kerian, , Malaysia
Site Status
GSK Investigational Site
Sarawak, , Malaysia
Site Status
GSK Investigational Site
Islamabad, , Pakistan
Site Status
GSK Investigational Site
Karachi, , Pakistan
Site Status
GSK Investigational Site
Karachi, , Pakistan
Site Status
GSK Investigational Site
Lahore, , Pakistan
Site Status
GSK Investigational Site
Lahore, , Pakistan
Site Status
GSK Investigational Site
Baguio City, Benguet, , Philippines
Site Status
GSK Investigational Site
Manila, , Philippines
Site Status
GSK Investigational Site
Quezon City, , Philippines
Site Status
GSK Investigational Site
Bialystok, , Poland
Site Status
GSK Investigational Site
Bydgoszcz, , Poland
Site Status
GSK Investigational Site
Krakow, , Poland
Site Status
GSK Investigational Site
Olsztyn, , Poland
Site Status
GSK Investigational Site
Poznan, , Poland
Site Status
GSK Investigational Site
Poznan, , Poland
Site Status
GSK Investigational Site
Bucharest, , Romania
Site Status
GSK Investigational Site
Iași, , Romania
Site Status
GSK Investigational Site
Timișoara, , Romania
Site Status
GSK Investigational Site
Banská Bystrica, , Slovakia
Site Status
GSK Investigational Site
Bratislava, , Slovakia
Site Status
GSK Investigational Site
Poprad, , Slovakia
Site Status
GSK Investigational Site
Seoul, , South Korea
Site Status
GSK Investigational Site
Seoul, , South Korea
Site Status
GSK Investigational Site
Seoul, , South Korea
Site Status
GSK Investigational Site
Ávila, , Spain
Site Status
GSK Investigational Site
Badalona, , Spain
Site Status
GSK Investigational Site
Madrid, , Spain
Site Status
GSK Investigational Site
Murcia, , Spain
Site Status
GSK Investigational Site
Valencia, , Spain
Site Status
GSK Investigational Site
Taichung, , Taiwan
Site Status
GSK Investigational Site
Taichung, , Taiwan
Site Status
GSK Investigational Site
TaoYuan Hsien, , Taiwan
Site Status
GSK Investigational Site
Bangkok, , Thailand
Site Status
GSK Investigational Site
Chiang Mai, , Thailand
Site Status
GSK Investigational Site
Kharkiv, , Ukraine
Site Status
GSK Investigational Site
Kyiv, , Ukraine
Site Status
GSK Investigational Site
Lviv, , Ukraine
Site Status
GSK Investigational Site
Sympheropol, , Ukraine
Site Status
GSK Investigational Site
Uzhhorod, , Ukraine
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Argentina
Belgium
Bulgaria
Croatia
Czechia
Finland
Greece
Hungary
India
Ireland
Italy
Malaysia
Pakistan
Philippines
Poland
Romania
Slovakia
South Korea
Spain
Taiwan
Thailand
Ukraine
References
Explore related publications, articles, or registry entries linked to this study.
Grunberg SM, Rolski J, Strausz J, Aziz Z, Lane S, Russo MW, Wissel P, Guckert M, Wright O, Herrstedt J. Efficacy and safety of casopitant mesylate, a neurokinin 1 (NK1)-receptor antagonist, in prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based highly emetogenic chemotherapy: a randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2009 Jun;10(6):549-58. doi: 10.1016/S1470-2045(09)70109-3. Epub 2009 May 8.
Reference Type
RESULT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NKV102551
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Study Of Prevention of Chemo-Induced Nausea and Vomiting Caused By Moderately Emetogenic Chemotherapy
NCT00104403
COMPLETED
PHASE2
A Study to Assess the Safety & Interaction Between GW679769, Dexamethasone, & Ondansetron When Taken by Healthy Adults
NCT00437229
COMPLETED
PHASE1
Olanzapine or Dexamethasone, With 5-HT3 RA and NK-1 RA, to Prevent CINV
NCT04437017
COMPLETED
PHASE3
Anti-emetic Prophylaxis With or Without Dexamethasone
NCT05242874
COMPLETED
PHASE3
Ondansetron Plus Dexamethasone With or Without Metoclopramide as Antiemetic Prophylaxis After Receiving Cisplatin
NCT01093690
COMPLETED
NA
Dexamethasone and Ondansetron Hydrochloride or Palonosetron Hydrochloride in Preventing Nausea and Vomiting in Patients Receiving Doxorubicin Hydrochloride and Cyclophosphamide For Early Stage Breast Cancer
NCT00343863
COMPLETED
NA
Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone in Germ Cell Tumors
NCT01736917
COMPLETED
PHASE2
Ph 3 Safety/Efficacy Study of Rolapitant for Prevention of CINV in Subjects Receiving Moderately Emetogenic Chemotherapy
NCT01500226
COMPLETED
PHASE3
Ondansetron With/Out Dexamethasone to Prevent Vomiting in Patients Receiving Radiation to the Upper Abdomen
NCT00016380
COMPLETED
PHASE3
Safety and Efficacy of Aprepitant, Ramosetron, and Dexamethasone for Chemotherapy-Induced Nausea and Vomiting in Patients With Ovarian Cancer Treated With Taxane/Carboplatin
NCT01012336
COMPLETED
PHASE2
Granisetron, Aprepitant, and Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Stage II, III, or IV Ovarian Cancer
NCT01275664
TERMINATED
NA
Low Dose Aprepitant for Patients Receiving Carboplatin
NCT03237611
TERMINATED
PHASE2
the Efficacy and Safety of 5-HT3 Receptor Antagonist, Dexamethasone or Megestrol Acetate Dispersible Tablets in the Control of Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy
NCT04430361
UNKNOWN
PHASE2
Palonosetron and Dexamethasone With or Without Dronabinol in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy For Cancer
NCT00553059
COMPLETED
PHASE3
Continuous Infusion of First-Generation 5-HT3 Receptor Antagonists in Combination With Dexamethasone
NCT05872893
UNKNOWN
PHASE3
Buccal Film Versus IV Injection Palonosetron for Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting
NCT04592198
COMPLETED
PHASE2
Treatment of Refractory Nausea and Vomiting in Patients With Breast Cancer
NCT03367572
COMPLETED
PHASE3
Dolasetron Mesylate and Dexamethasone With or Without Aprepitant in Preventing Nausea and Vomiting in Patients Undergoing Oxaliplatin-Containing Chemotherapy for Gastrointestinal Malignancy
NCT02550119
TERMINATED
NA
Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy
NCT01500213
COMPLETED
PHASE3
Dexamethasone-sparing Approach Including NEPA Against Emesis Caused by Cisplatin
NCT04201769
UNKNOWN
PHASE3
Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Gynecologic Oncology Patients
NCT04503668
TERMINATED
PHASE3
Aprepitant in the Prevention of Cisplatin-induced Delayed Emesis
NCT00869310
TERMINATED
PHASE3
Drugs to Reduce the Side Effects of Chemotherapy
NCT00003213
COMPLETED
PHASE3