CancerPhase 3NCT00891761
A Study of IV Casopitant for the Prevention of Nausea and Vomiting Caused By Cisplatin-Based Highly Emetogenic Chemotherapy
A Phase 3 study testing Dexamethasone, IV casopitant (active) and Ondansetron in people with Cancer and Chemotherapy-Induced Nausea and Vomiting, run by GlaxoSmithKline at 3 sites in 2 countries.
Trial summary
This is a phase III study designed to demonstrate the superiority of single-dose 90 mg intravenous (IV) casopitant over placebo, each in combination with ondansetron and dexamethasone, for the prevention of emesis over the first 0-120 hours (overall phase) following initiation of the cisplatin infusion in the first… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Chemotherapy-Induced Nausea and Vomiting, Nausea and Vomiting
- What is being tested?
- Dexamethasone, IV casopitant (active) and Ondansetron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Sep 2009to Jul 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject will be considered eligible for initial inclusion in this study, and progression into subsequent cycles of therapy within the 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 oxaliplatin at a dose between 85 mg/m2 and 130 mg/m2 in their first cycle of therapy for the treatment of colorectal cancer, administered as a single IV dose over 2-6 hours on Day 1 only, in combination with 5FU/LV, or in combination with capecitabine. Refer to Section 4.1 for the list of chemotherapy agents that may be added to oxaliplatin.
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Hematologic and metabolic status adequate for receiving an oxaliplatin-based moderately emetogenic regimen and meeting the following criteria:
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- Total Neutrophils ≥1500/mm3 (Standard units : ≥1.5 x 109/L)
- Platelets ≥100,000/mm3 (Standard units: ≥100.0 x 109/L)
- Bilirubin ≤1.5 x upper limit of normal (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) = K x (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 ULN.
- With known liver metastases: AST and/or ALT ≤5.0 x ULN.
- Is willing and able to complete daily components of the Subject Diary for Cycle 1 and Cycle 2 without assistance from others.
- A female subject is eligible to enter and participate in this study if she is of:
- non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal. For purposes of this study, postmenopausal is defined as one year without menses)
- child-bearing potential: must have a negative serum pregnancy test result or negative urine dipstick pregnancy test within 24 hours prior to the first dose of investigational product on Cycle 1 Day 1. Women of childbearing potential must also 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 the physician, are as follows:
- 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 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 3 days);
- if subject indicates they will remain abstinent during the period described above, they must agree to follow GSK guidelines for the consistent and correct use of an acceptable method of birth control should they become sexually active.
Who cannot join
- A subject will not be eligible for initial inclusion in this study if any of the following criteria apply, or will not be eligible for subsequent cycles of therapy if any of the following criteria become applicable:
- Has received cytotoxic chemotherapy prior to the first study cycle of chemotherapy, with the exception that previous adjuvant therapy with 5FU/LV or capecitabine is permitted, provided that the last dose of adjuvant therapy was completed at least 6 months prior to receiving the first dose of study medication or investigational product. Previous biological or hormonal therapy completed at any time is permitted.
- Scheduled to receive chemotherapy with any cytotoxic agents (e.g., irinotecan, gemcitabine) or biological agents (e.g., cetuximab, panitumimab) other than the protocol allowed chemotherapy described in Inclusion Criterion 3.
- Is a female subject who is pregnant or lactating.
- Has received radiation therapy in the 10 days prior to the first dose of study medication or investigational product and/or is scheduled to receive such radiation therapy in the 6 days following the first dose of study medication or investigational product in the first cycle of chemotherapy. Radiation therapy may be added in subsequent cycles of chemotherapy.
- 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 investigational product for each cycle of chemotherapy.
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- Has known central nervous system metastasis, unless previously successfully treated with excision or radiation, and has been stable for at least 1 week immediately prior to receiving the first dose of study medication or investigational product.
- Has increased intracranial pressure, hypercalcemia, an active systemic infection, 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 ondansetron, another 5-HT3 receptor antagonist, dexamethasone, or any component of casopitant.
- Has received an NK-1 receptor antagonist prior to the first study cycle of chemotherapy.
- Has received an investigational drug within the previous 30 days or 5 half-lives (whichever is longer) prior to receiving the first dose of study medication or investigational product, or is scheduled to receive any investigational drug other than casopitant/placebo during the study period.
- Has taken/received any medication of moderate or high emetogenic potential (including antineoplastic agents [see Appendix 2]) within the 48 hours prior to the first dose of study medication or investigational product in each cycle. However, opioid narcotics will be permitted if the subject has been on such medication for at least 7 days at a stable dose prior to the start of each cycle, 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 (unless otherwise stated) prior to receiving the first dose of study medication or investigational product or is expected to require use of such medication during the 120 hour assessment period for Cycle 1 of therapy only. This includes, but is not limited to:
- 5-HT3 receptor antagonists (e.g., additional ondansetron, or granisetron, dolasetron, tropisetron, ramosetron). Palonosetron is not permitted within 7 days prior to administration of study medication or 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 7 days prior to the first dose of 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);
- butyrophenones (e.g., haloperidol, droperidol);
- corticosteroids within 72 hours prior to the first dose of study medication or investigational product (e.g., dexamethasone, methylprednisolone); with the exception that topical steroids for skin disorders including eye and ear drops, and inhaled steroids for respiratory disorders at no more than 10 mg prednisone daily or its equivalent are permitted;
- anticholinergics (e.g., scopolamine); with the exception that anticholinergics for the treatment of respiratory disorders and the management of diarrhea (e.g., ipratropium bromide, and hyoscyamine) and anticholinergic eye drops are permitted;
- first-generation antihistamines (e.g., cyclizine, hydroxyzine, diphenhydramine) except for topical use which is permitted;
- domperidone;
- cannabinoids;
- mirtazapine;
- olanzapine.
- Has taken/received strong or moderate inhibitors of CYP3A4 and CYP3A5 for a specified period prior to administration of investigational product in each cycle of therapy.
- Has taken/received inducers of CYP3A4 and CYP3A5 within 14 days prior to the administration of investigational product in each cycle of therapy.
- Is currently taking, or plans to take the following CYP2C8 substrates at any time during the study: the anti-diabetic agent repaglinide or the diuretic torsemide.
- Is currently taking, or plans to take any of the following CYP3A4 substrates at any time during the study: astemizole, cisapride, pimozide, terfenadine.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
GSK Investigational Site
Robbinsdale, Minnesota, 55422
GSK Investigational Site
Tampa, Florida, 33614
About this study
Official title: A Study of Single Dose Intravenous Casopitant in Combination With Ondansetron and Dexamethasone for the Prevention of Cisplatin-Induced Nausea and Vomiting
This is a phase III study designed to demonstrate the superiority of single-dose 90 mg intravenous (IV) casopitant over placebo, each in combination with ondansetron and dexamethasone, for the prevention of emesis over the first 0-120 hours (overall phase) following initiation of the cisplatin infusion in the first cycle of highly emetogenic chemotherapy (HEC). Eligibility is limited to subjects who are scheduled to receive their first cycle of chemotherapy which includes at least 60 mg/m2 of cisplatin administered on Day 1 only of a 21 day or 28 day cycle. All subjects will receive IV ondansetron and oral dexamethasone on Day 1 prior to initiation of the cisplatin infusion, followed by oral dexamethasone on Days 2-4. Additionally, subjects will be randomized to receive single-dose 90 mg IV casopitant or matching placebo prior to initiation of a cisplatin-based HEC regimen.
- Being tested
- Dexamethasone, IV casopitant (placebo), IV casopitant (active), Ondansetron
- Keywords
- cisplatin, nausea, vomiting, cancer, lung cancer
- Medical subject headings
- Neoplasms, Vomiting, Nausea, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
16 mg administered orally within 75 minutes prior to the initiation of cisplatin on Day 1, followed by 8 mg doses twice daily (bid) at approximately 12+/-4 hour intervals on days 2, 3, and 4, starting at approximately the same time of day as the Day 1 dose was administered.
DexamethasoneDrug
20 mg administered orally within 75 minutes prior to the initiation of cisplatin on Day 1, followed by 8 mg doses twice daily (bid) at approximately 12+/-4 hour intervals on days 2, 3, and 4, starting at approximately the same time of day as the Day 1 dose was administered.
IV casopitant (placebo)Drug
IV casopitant (placebo) administered within 75 minutes prior to the start of cisplatin-based highly emetogenic chemotherapy on study day 1.
IV casopitant (active)Drug
Single-dose 90 mg IV casopitant administered within 75 minutes prior to the start of cisplatin-based highly emetogenic chemotherapy on study Day 1.
OndansetronDrug
32mg IV ondansetron administered over not less than 15 minutes, with administration started and completed within the 75 minutes prior to the initiation of cisplatin therapy on study Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator | Active comparator | Patients receive IV casopitant (active), IV ondansetron and oral dexamethasone on Day 1 as well as oral dexamethasone on Days 2-4 of each cycle of cisplatin-based highly emetogenic chemotherapy for the prevention of chemotherapy induced nausea and vomiting. Receives: Drug: Dexamethasone; Drug: IV casopitant (active); Drug: Ondansetron |
| Placebo Comparator | Placebo comparator | Patients receive IV casopitant (placebo), IV ondansetron and oral dexamethasone on Day 1 as well as oral dexamethasone on Days 2-4 of each cycle of cisplatin-based highly emetogenic chemotherapy for the prevention of chemotherapy induced nausea and vomiting. Receives: Drug: Dexamethasone; Drug: IV casopitant (placebo); Drug: Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects who achieve a complete response (defined as no vomiting/retching and no rescue therapy).
Measured: Overall phase (0-120 hours) following initiation of the first cycle of a cisplatin-based HEC regimen.
Secondary outcomes (15)
The proportion of subjects who vomit/retch
Measured: Acute, delayed and overall phases of Cycle 1
The proportion of subjects who receive anti-emetic rescue medication
Measured: Acute, delayed and overall phases of Cycle 1
Maximum nausea score (to assess the severity of nausea), assessed by a Visual Analogue Scale (VAS).
Measured: Acute, delayed and overall phases of Cycle 1
The proportion of subjects reporting significant nausea, defined as a maximum nausea score of at least 25 mm on the VAS.
Measured: Acute, delayed and overall phases of Cycle 1
The proportion of subjects who achieve a complete response
Measured: Acute (0-24 hrs) and delayed (24-120 hrs) phases of Cycle 1
The proportion of subjects reporting nausea, defined as a maximum nausea score of at least 5 mm on the VAS.
Measured: Acute, delayed and overall phases of Cycle 1
The proportion of subjects achieving complete protection, defined as complete responders who had no significant nausea.
Measured: Acute, delayed and overall phases of Cycle 1
The proportion of subjects achieving total control, defined as complete responders who had no nausea.
Measured: Acute, delayed and overall phases of Cycle 1
Time to first anti-emetic rescue medication.
Measured: Acute, delayed and overall phases of Cycle 1
Time to first emetic event.
Measured: Acute, delayed and overall phases of Cycle 1
Time to loss of complete response.
Measured: Acute, delayed and overall phases of Cycle 1
The proportion of subjects who achieve a complete response.
Measured: Extended overall phase (0-216 hrs) of Cycle 1
The proportion of subjects who achieve a complete response.
Measured: Overall (0-120 hrs), acute and delayed phases of Cycle 2
The impact on subjects' daily life activities, as assessed by the FLIE questionnaire.
Measured: Overall phase (0-120 hrs) of Cycle 1.
Assessment of the safety and tolerability of casopitant through routine physical exam, routine clinical laboratory tests, clinical monitoring and AE reporting.
Measured: All cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study startSep 2009
- Primary completionJul 2010 (estimated)
- Study completionJul 2010 (estimated)
Why it stopped: This study has been cancelled prior to enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891761
- Sponsor's protocol ID
- 112512
- Status last verified
- Apr 2015
- First submitted
- 30 Apr 2009
- Last updated
- 17 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Single Dose Intravenous Casopitant in Combination With Ondansetron and Dexamethasone for the Prevention of Cisplatin-Induced Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT00891761
- Acronym / sponsor ID
- 112512
- Keywords
- cisplatin, nausea, vomiting, cancer, lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study has been cancelled prior to enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 1 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase III study designed to demonstrate the superiority of single-dose 90 mg intravenous (IV) casopitant over placebo, each in combination with ondansetron and dexamethasone, for the prevention of emesis over the first 0-120 hours (overall phase) following initiation of the cisplatin infusion in the first cycle of highly emetogenic chemotherapy (HEC). Eligibility is limited to subjects who are scheduled to receive their first cycle of chemotherapy which includes at least 60 mg/m2 of cisplatin administered on Day 1 only of a 21 day or 28 day cycle. All subjects will receive IV ondansetron and oral dexamethasone on Day 1 prior to initiation of the cisplatin infusion, followed by oral dexamethasone on Days 2-4. Additionally, subjects will be randomized to receive single-dose 90 mg IV casopitant or matching placebo prior to initiation of a cisplatin-based HEC regimen.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Active comparator | Drug: Dexamethasone, Drug: IV casopitant (active), Drug: OndansetronPatients receive IV casopitant (active), IV ondansetron and oral dexamethasone on Day 1 as well as oral dexamethasone on Days 2-4 of each cycle of cisplatin-based highly emetogenic chemotherapy for the prevention of chemotherapy induced nausea and vomiting. |
| Placebo Comparator | Placebo comparator | Drug: Dexamethasone, Drug: IV casopitant (placebo), Drug: OndansetronPatients receive IV casopitant (placebo), IV ondansetron and oral dexamethasone on Day 1 as well as oral dexamethasone on Days 2-4 of each cycle of cisplatin-based highly emetogenic chemotherapy for the prevention of chemotherapy induced nausea and vomiting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- A subject will be considered eligible for initial inclusion in this study, and progression into subsequent cycles of therapy within the 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 oxaliplatin at a dose between 85 mg/m2 and 130 mg/m2 in their first cycle of therapy for the treatment of colorectal cancer, administered as a single IV dose over 2-6 hours on Day 1 only, in combination with 5FU/LV, or in combination with capecitabine. Refer to Section 4.1 for the list of chemotherapy agents that may be added to oxaliplatin.
- An Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Key exclusion criteria (29 listed)
- A subject will not be eligible for initial inclusion in this study if any of the following criteria apply, or will not be eligible for subsequent cycles of therapy if any of the following criteria become applicable:
- Has received cytotoxic chemotherapy prior to the first study cycle of chemotherapy, with the exception that previous adjuvant therapy with 5FU/LV or capecitabine is permitted, provided that the last dose of adjuvant therapy was completed at least 6 months prior to receiving the first dose of study medication or investigational product. Previous biological or hormonal therapy completed at any time is permitted.
- Scheduled to receive chemotherapy with any cytotoxic agents (e.g., irinotecan, gemcitabine) or biological agents (e.g., cetuximab, panitumimab) other than the protocol allowed chemotherapy described in Inclusion Criterion 3.
- Is a female subject who is pregnant or lactating.
- Has received radiation therapy in the 10 days prior to the first dose of study medication or investigational product and/or is scheduled to receive such radiation therapy in the 6 days following the first dose of study medication or investigational product in the first cycle of chemotherapy. Radiation therapy may be added in subsequent cycles of chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone16 mg administered orally within 75 minutes prior to the initiation of cisplatin on Day 1, followed by 8 mg doses twice daily (bid) at approximately 12+/-4 hour intervals on days 2, 3, and 4, starting at approximately the same time of day as the Day 1 dose was administered. | Drug | Active Comparator |
| Dexamethasone20 mg administered orally within 75 minutes prior to the initiation of cisplatin on Day 1, followed by 8 mg doses twice daily (bid) at approximately 12+/-4 hour intervals on days 2, 3, and 4, starting at approximately the same time of day as the Day 1 dose was administered. | Drug | Placebo Comparator |
| IV casopitant (placebo)IV casopitant (placebo) administered within 75 minutes prior to the start of cisplatin-based highly emetogenic chemotherapy on study day 1. | Drug | Placebo Comparator |
| IV casopitant (active)Single-dose 90 mg IV casopitant administered within 75 minutes prior to the start of cisplatin-based highly emetogenic chemotherapy on study Day 1. | Drug | Active Comparator |
| Ondansetron32mg IV ondansetron administered over not less than 15 minutes, with administration started and completed within the 75 minutes prior to the initiation of cisplatin therapy on study Day 1. | Drug | Active Comparator, Placebo Comparator |
Primary outcome
The proportion of subjects who achieve a complete response (defined as no vomiting/retching and no rescue therapy).
Time frame: Overall phase (0-120 hours) following initiation of the first cycle of a cisplatin-based HEC regimen.
15 secondary outcomes
The proportion of subjects who vomit/retch
Time frame: Acute, delayed and overall phases of Cycle 1
The proportion of subjects who receive anti-emetic rescue medication
Time frame: Acute, delayed and overall phases of Cycle 1
Maximum nausea score (to assess the severity of nausea), assessed by a Visual Analogue Scale (VAS).
Time frame: Acute, delayed and overall phases of Cycle 1
The proportion of subjects reporting significant nausea, defined as a maximum nausea score of at least 25 mm on the VAS.
Time frame: Acute, delayed and overall phases of Cycle 1
The proportion of subjects who achieve a complete response
Time frame: Acute (0-24 hrs) and delayed (24-120 hrs) phases of Cycle 1
The proportion of subjects reporting nausea, defined as a maximum nausea score of at least 5 mm on the VAS.
Time frame: Acute, delayed and overall phases of Cycle 1
The proportion of subjects achieving complete protection, defined as complete responders who had no significant nausea.
Time frame: Acute, delayed and overall phases of Cycle 1
The proportion of subjects achieving total control, defined as complete responders who had no nausea.
Time frame: Acute, delayed and overall phases of Cycle 1
Time to first anti-emetic rescue medication.
Time frame: Acute, delayed and overall phases of Cycle 1
Time to first emetic event.
Time frame: Acute, delayed and overall phases of Cycle 1
Time to loss of complete response.
Time frame: Acute, delayed and overall phases of Cycle 1
The proportion of subjects who achieve a complete response.
Time frame: Extended overall phase (0-216 hrs) of Cycle 1
The proportion of subjects who achieve a complete response.
Time frame: Overall (0-120 hrs), acute and delayed phases of Cycle 2
The impact on subjects' daily life activities, as assessed by the FLIE questionnaire.
Time frame: Overall phase (0-120 hrs) of Cycle 1.
Assessment of the safety and tolerability of casopitant through routine physical exam, routine clinical laboratory tests, clinical monitoring and AE reporting.
Time frame: All cycles
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone, IV casopitant (active) and Ondansetron in people with Cancer and Chemotherapy-Induced Nausea and Vomiting, run by GlaxoSmithKline at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects who achieve a complete response (defined as no vomiting/retching and no rescue therapy). (time frame: Overall phase (0-120 hours) following initiation of the first cycle of a cisplatin-based HEC regimen.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2015.