Chemotherapy-Induced Nausea and Vomiting (CINV)Phase 3NCT01594749

Efficacy and Safety of Fosaprepitant Dimeglumine in Preventing Chemotherapy-Induced Nausea and Vomiting (MK-0517-031)

A Phase 3 study testing Fosaprepitant dimeglumine, Dexamethasone and Ondansetron in people with Chemotherapy-Induced Nausea and Vomiting (CINV), run by Merck Sharp & Dohme LLC.

Completed

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

Official record

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Trial summary

This study aims to demonstrate that, when given concomitantly with a 5-hydroxytryptamine 3 (5-HT3) antagonist and a corticosteroid, a single 150 mg intravenous (IV) dose of fosaprepitant given on Day 1 is superior to the control regimen of 5-HT3 antagonist and corticosteroid only, in preventing chemotherapy-induced… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chemotherapy-Induced Nausea and Vomiting (CINV)
What is being tested?: Fosaprepitant dimeglumine, Dexamethasone 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: 1,015 participants
Where: No sites listed yet
Study dates: 24 Sep 2012to 3 Nov 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Has a histologically or cytologically confirmed malignant disease
Is naive to moderately and highly emetogenic chemotherapy
Is scheduled to receive a single IV dose of one or more MEC agents on Day 1, except for the combination of anthracycline and cyclophosphamide
Has a predicted life expectancy of at least 4 months, and a Karnofsky score of at least 60 indicating that the participant requires occasional assistance, but is able to care for most of his/her needs.
Female of childbearing potential demonstrates a negative urine pregnancy test, and agrees to remain abstinent or use two acceptable forms of birth control for at least 14 days prior to study, throughout the study, and at least 1 month following last dose of study drug.

Who cannot join

Has vomited in the 24 hours prior to treatment Day 1
Has symptomatic primary or metastatic symptomatic central nervous system malignancy causing nausea and/or vomiting
Is scheduled to receive chemotherapy agent classified as highly emetogenic
Has received or will receive total body irradiation, or radiation therapy to the abdomen, pelvis, head and neck in the week prior to Treatment Days 1 through Day 6 of the Treatment Period
Has illness or history of illness which might confound study results or pose unwarranted risk
Known history of QT interval prolongation

Show all 12Show fewer

Uses illicit drugs or abuses alcohol
Mentally incapacitated or has a significant emotional or psychiatric disorder
History of hypersensitivity to aprepitant, ondansetron or dexamethasone
Pregnant or breast-feeding
Has participated in a study with aprepitant or taken a non-approved (investigational) drug within the last 4 weeks
Has concurrent condition, such as systemic fungal infection or uncontrolled diabetes, that precludes administration of dexamethasone.

About this study

Official title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Efficacy and Safety of a Single 150 mg Dose of Intravenous Fosaprepitant Dimeglumine for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With Moderately Emetogenic Chemotherapy

Conditions: Chemotherapy-Induced Nausea and Vomiting (CINV)
Being tested: Fosaprepitant dimeglumine, Fosaprepitant Placebo, Dexamethasone, Ondansetron, Dexamethasone Placebo
Keywords: NK-1 Receptor Antagonist, CINV, Emesis, MEC
Medical subject headings: Vomiting

What participants receive

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

Fosaprepitant dimeglumineDrug
Also called EMEND for Injection, MK-0517
Fosaprepitant PlaceboDrug
DexamethasoneDrug
Also called Decadron
OndansetronDrug
Also called Zofran
Dexamethasone PlaceboDrug
Ondansetron PlaceboDrug
Rescue TherapyDrug

Study groups in NCT01594749
Study group	Role	What they receive
Fosaprepitant Regimen	Experimental	On Day 1, participants received fosaprepitant, 150 mg intravenous (IV) infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, orally (PO) ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone. Receives: Drug: Fosaprepitant dimeglumine; Drug: Dexamethasone; Drug: Ondansetron; Drug: Dexamethasone Placebo; Drug: Ondansetron Placebo; Drug: Rescue Therapy
Control Regimen	Active comparator	On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone. Receives: Drug: Fosaprepitant Placebo; Drug: Dexamethasone; Drug: Ondansetron; Drug: Rescue Therapy

What is being measured

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

Percentage of Participants With Complete Response From 25 to 120 Hours After Initiation of Moderately Emetogenic Chemotherapy (MEC)
A Complete Response was defined as no vomiting and no use of rescue medication.
Measured: 25 to 120 hours after initiation of MEC
Percentage of Participants With Infusion-site Thrombophlebitis
The percentages of participants with infusion-site thrombophlebitis are presented. Thrombophlebitis was defined as a condition affecting a superficial vein used for an IV infusion, associated with red color, hardness upon palpation, and the presence of a tender cord and possible fever.
Measured: Day 1 through Day 17, inclusive
Percentage of Participants With Severe Infusion-site Reactions
The percentages of participants with severe infusion-site reactions, including severe site pain, or severe site redness (erythema) or severe site hardness (induration) are presented.
Measured: Day 1 through Day 17, inclusive

Secondary outcomes (3)

Percentage of Participants With Complete Response From 0 to 120 Hours After Initiation of MEC
A Complete Response was defined as no vomiting and no use of rescue medication.
Measured: 0 to 120 hours after initiation of MEC
Percentage of Participants With Complete Response From 0 to 24 Hours After Initiation of MEC
A Complete Response was defined as no vomiting and no use of rescue medication.
Measured: 0 to 24 hours after initiation of MEC
Percentage of Participants With No Vomiting From 0 to 120 Hours After Initiation of MEC
No Vomiting was defined as no emetic (vomiting) episodes, including no vomiting and no retching or dry heaves (attempts to vomit that are not productive of stomach contents), regardless of use of rescue medication.
Measured: 0 to 120 hours after initiation of MEC

Timeline

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

24 Sep 20123 Nov 2014

First posted9 May 2012 (estimated)
Study start24 Sep 2012
Primary completion3 Nov 2014
Study completion3 Nov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Chemotherapy-Induced Nausea and Vomiting (CINV)Studies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,015 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01594749
Sponsor's protocol ID: 0517-031
Status last verified: Aug 2018
First submitted: 24 Apr 2012
Last updated: 4 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Weinstein C, Jordan K, Green SA, Camacho E, Khanani S, Beckford-Brathwaite E, Vallejos W, Liang LW, Noga SJ, Rapoport BL. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy: results of a randomized, double-blind phase III trial. Ann Oncol. 2016 Jan;27(1):172-8. doi: 10.1093/annonc/mdv482. Epub 2015 Oct 8.
PubMed 26449391
Weinstein C, Jordan K, Green S, Khanani S, Beckford-Brathwaite E, Vallejos W, Pong A, Noga SJ, Rapoport BL. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy regimens: a subgroup analysis from a randomized clinical trial of response in subjects by cancer type. BMC Cancer. 2020 Sep 25;20(1):918. doi: 10.1186/s12885-020-07259-5.
PubMed 32988373
Weinstein C, Jordan K, Green SA, Camacho E, Khanani S, Beckford-Brathwaite E, Pong A, Noga SJ, Rapoport BL. Evaluation of factors contributing to the response to fosaprepitant in a heterogeneous, moderately emetogenic chemotherapy population: an exploratory analysis of a randomized phase III trial. Support Care Cancer. 2018 Nov;26(11):3773-3780. doi: 10.1007/s00520-018-4242-x. Epub 2018 May 28.
PubMed 29808377

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 2
A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer
Nausea, Vomiting
RecruitingObservational study
HR20013 for the Prevention of Nausea and Vomiting in Patients With Cancer: A Real-World Study
Chemotherapy-Induced Nausea and Vomiting (CINV), Nausea
RecruitingPhase 1
A Study to Compare the Bioavailability of Ondansetron Following Nasal (NS003) and IV Administration in Healthy Adults
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RecruitingPhase 2
Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Paediatric Cancer Patients Undergoing Highly Emetogenic Chemotherapy (HEC)
Nausea and Vomiting Chemotherapy-Induced, Nausea Post Chemotherapy
Not yet recruitingPhase 1
QLM2010 Comparative Pharmacokinetic Study With 2-Minute Intravenous Administration
Chemotherapy-Induced Nausea and Vomiting (CINV)

All Chemotherapy-Induced Nausea and Vomiting (CINV) trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Efficacy and Safety of a Single 150 mg Dose of Intravenous Fosaprepitant Dimeglumine for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With Moderately Emetogenic Chemotherapy
ClinicalTrials.gov ID: NCT01594749
Acronym / sponsor ID: 0517-031
Conditions: Chemotherapy-Induced Nausea and Vomiting (CINV)
Keywords: NK-1 Receptor Antagonist, CINV, Emesis, MEC
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,015 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 24 Sep 2012 (actual)
Primary completion: 3 Nov 2014 (actual)
Study completion: 3 Nov 2014 (actual)
First posted: 9 May 2012 (estimated)
Results: Posted 25 Sep 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Fosaprepitant Regimen	Experimental	Drug: Fosaprepitant dimeglumine, Drug: Dexamethasone, Drug: Ondansetron, Drug: Dexamethasone Placebo, Drug: Ondansetron Placebo, Drug: Rescue TherapyOn Day 1, participants received fosaprepitant, 150 mg intravenous (IV) infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, orally (PO) ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
Control Regimen	Active comparator	Drug: Fosaprepitant Placebo, Drug: Dexamethasone, Drug: Ondansetron, Drug: Rescue TherapyOn Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Has a histologically or cytologically confirmed malignant disease
Is naive to moderately and highly emetogenic chemotherapy
Is scheduled to receive a single IV dose of one or more MEC agents on Day 1, except for the combination of anthracycline and cyclophosphamide
Has a predicted life expectancy of at least 4 months, and a Karnofsky score of at least 60 indicating that the participant requires occasional assistance, but is able to care for most of his/her needs.
Female of childbearing potential demonstrates a negative urine pregnancy test, and agrees to remain abstinent or use two acceptable forms of birth control for at least 14 days prior to study, throughout the study, and at least 1 month following last dose of study drug.

Key exclusion criteria (12 listed)

Has vomited in the 24 hours prior to treatment Day 1
Has symptomatic primary or metastatic symptomatic central nervous system malignancy causing nausea and/or vomiting
Is scheduled to receive chemotherapy agent classified as highly emetogenic
Has received or will receive total body irradiation, or radiation therapy to the abdomen, pelvis, head and neck in the week prior to Treatment Days 1 through Day 6 of the Treatment Period
Has illness or history of illness which might confound study results or pose unwarranted risk

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
Fosaprepitant dimeglumineAlso: EMEND for Injection, MK-0517	Drug	Fosaprepitant Regimen
Fosaprepitant Placebo	Drug	Control Regimen
DexamethasoneAlso: Decadron	Drug	Control Regimen, Fosaprepitant Regimen
OndansetronAlso: Zofran	Drug	Control Regimen, Fosaprepitant Regimen
Dexamethasone Placebo	Drug	Fosaprepitant Regimen
Ondansetron Placebo	Drug	Fosaprepitant Regimen
Rescue Therapy	Drug	Control Regimen, Fosaprepitant Regimen

Primary outcome

Percentage of Participants With Complete Response From 25 to 120 Hours After Initiation of Moderately Emetogenic Chemotherapy (MEC)
Time frame: 25 to 120 hours after initiation of MEC
A Complete Response was defined as no vomiting and no use of rescue medication.
Percentage of Participants With Infusion-site Thrombophlebitis
Time frame: Day 1 through Day 17, inclusive
The percentages of participants with infusion-site thrombophlebitis are presented. Thrombophlebitis was defined as a condition affecting a superficial vein used for an IV infusion, associated with red color, hardness upon palpation, and the presence of a tender cord and possible fever.
Percentage of Participants With Severe Infusion-site Reactions
Time frame: Day 1 through Day 17, inclusive
The percentages of participants with severe infusion-site reactions, including severe site pain, or severe site redness (erythema) or severe site hardness (induration) are presented.

3 secondary outcomes

Percentage of Participants With Complete Response From 0 to 120 Hours After Initiation of MEC
Time frame: 0 to 120 hours after initiation of MEC
Percentage of Participants With Complete Response From 0 to 24 Hours After Initiation of MEC
Time frame: 0 to 24 hours after initiation of MEC
Percentage of Participants With No Vomiting From 0 to 120 Hours After Initiation of MEC
Time frame: 0 to 120 hours after initiation of MEC

Results and safety

Results posted to the registry on 25 Sep 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fosaprepitant Regimen	507	485
Control Regimen	508	490

Primary outcome: Percentage of Participants With Complete Response From 25 to 120 Hours After Initiation of Moderately Emetogenic Chemotherapy (MEC)

Time frame: 25 to 120 hours after initiation of MEC. Number. Unit: Percentage of Participants

Measure	Fosaprepitant Regimen n = 502	Control Regimen n = 498
Value	78.9	68.5

Fosaprepitant Regimen vs Control Regimen: p <0.001, Cochran-Mantel-Haenszel

Population analysed: The ITT population consisted of all randomized participants who received ≥1 dose of study drug within the assigned treatment regimen. One participant in the Fosaprepitant Regimen was excluded from the ITT population due to missing source documentation. One participant in the Control Regimen was treated with fosaprepitant in error.

Primary outcome: Percentage of Participants With Infusion-site Thrombophlebitis

Time frame: Day 1 through Day 17, inclusive. Number. Unit: Percentage of Participants

Measure	Fosaprepitant Regimen n = 504	Control Regimen n = 497
Value	0.6	0.0

Fosaprepitant Regimen vs Control Regimen: Difference in percentage vs. Control: 0.6 (95% CI -0.2 to 1.7), p = 0.085, Miettinen & Nurminen method

Population analysed: The Safety population consisted of all randomized participants who received study drug as treated.

Primary outcome: Percentage of Participants With Severe Infusion-site Reactions

Time frame: Day 1 through Day 17, inclusive. Number. Unit: Percentage of Participants

Measure	Fosaprepitant Regimen n = 504	Control Regimen n = 497
Value	0.0	0.0

Population analysed: The Safety population consisted of all randomized participants who received study drug as treated.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 1 up to Day 17, inclusive (Up to 2 weeks after last dose of study drug). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fosaprepitant Regimen	39 of 504 (7.7%)	190 of 504 (37.7%)	Not reported
Control Regimen	35 of 497 (7%)	193 of 497 (38.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26449391Weinstein C, Jordan K, Green SA, Camacho E, Khanani S, Beckford-Brathwaite E, Vallejos W, Liang LW, Noga SJ, Rapoport BL. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy: results of a randomized, double-blind phase III trial. Ann Oncol. 2016 Jan;27(1):172-8. doi: 10.1093/annonc/mdv482. Epub 2015 Oct 8.
Derived from this study: PubMed 32988373Weinstein C, Jordan K, Green S, Khanani S, Beckford-Brathwaite E, Vallejos W, Pong A, Noga SJ, Rapoport BL. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy regimens: a subgroup analysis from a randomized clinical trial of response in subjects by cancer type. BMC Cancer. 2020 Sep 25;20(1):918. doi: 10.1186/s12885-020-07259-5.
Derived from this study: PubMed 29808377Weinstein C, Jordan K, Green SA, Camacho E, Khanani S, Beckford-Brathwaite E, Pong A, Noga SJ, Rapoport BL. Evaluation of factors contributing to the response to fosaprepitant in a heterogeneous, moderately emetogenic chemotherapy population: an exploratory analysis of a randomized phase III trial. Support Care Cancer. 2018 Nov;26(11):3773-3780. doi: 10.1007/s00520-018-4242-x. Epub 2018 May 28.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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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.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fosaprepitant dimeglumine, Dexamethasone and Ondansetron in people with Chemotherapy-Induced Nausea and Vomiting (CINV), run by Merck Sharp & Dohme LLC.

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 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

Yes. Results are posted in the registry (first posted 25 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Complete Response From 25 to 120 Hours After Initiation of Moderately Emetogenic Chemotherapy (MEC) (time frame: 25 to 120 hours after initiation of MEC). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01594749, which also lists 3 linked publications.

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 4 Sep 2018.