Chemotherapy-Induced Nausea and VomitingPhase 3NCT00337727
Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)(0869-130)(COMPLETED)
A Phase 3 study testing aprepitant, Comparator: ondansetron and Comparator: dexamethasone in people with Chemotherapy-Induced Nausea and Vomiting, run by Merck Sharp & Dohme LLC.
Trial summary
The study will test aprepitant for the prevention of CINV in patients receiving their initial cycle of Moderately Emetogenic Chemotherapy (MEC). Patients receiving more then one cycle of chemotherapy may opt to participate in an optional second cycle during which the patient will receive the same antiemetic regimen as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy-Induced Nausea and Vomiting
- What is being tested?
- aprepitant, Comparator: ondansetron and Comparator: dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 848 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2007to 19 Nov 2008
- 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
- Patients will be naive to emetogenic chemotherapy with histologically or cytologically confirmed malignant disease scheduled to receive a single dose of moderately emetogenic chemotherapy on study day 1
- Karnofsky score of 60 or greater
Who cannot join
- Patient is scheduled to receive any dose of cisplatin
- Patient will receive abdominal or pelvic radiation a week prior and up to 6 days after initiation of chemotherapy
- Any allergies to study drug or antiemetics
- Taking CYP3A4 substrates/prohibited medication
- Significant medical or mental conditions
- Abnormal laboratory values (platelets, absolute neutrophils, AST, ALT, bilirubin or creatinine).
About this study
Official title: A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Moderately Emetogenic Chemotherapy (MEC)
The study will test aprepitant for the prevention of CINV in patients receiving their initial cycle of Moderately Emetogenic Chemotherapy (MEC). Patients receiving more then one cycle of chemotherapy may opt to participate in an optional second cycle during which the patient will receive the same antiemetic regimen as cycle 1, except that an IV formulation of aprepitant will be given in place of the oral formulation on study day one. Study drug administration on subsequent days will be given orally as in cycle 1.
- Conditions
- Chemotherapy-Induced Nausea and Vomiting
- Being tested
- aprepitant, Comparator: ondansetron, Comparator: dexamethasone, Comparator: fosaprepitant dimeglumine, Comparator; Placebo (unspecified)
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aprepitantDrug
Also called MK0869
aprepitant 125 mg capsule; aprepitant 80 mg capsule Three day treatment period.
Comparator: ondansetronDrug
Also called Zofran®
Ondansetron 8 mg capsule Three day treatment period.
Comparator: dexamethasoneDrug
Also called DEXAMETHASONE TABLETS USP
dexamethasone 12 mg tablets; 20 mg tablets Three day treatment period.
Comparator: fosaprepitant dimeglumineDrug
Also called EMEND®
fosaprepitant dimeglumine 115 mg
Comparator; Placebo (unspecified)Drug
dexamethasone 12mg Pbo tablets.
Comparator; Placebo (unspecified)Drug
Aprepitant 80 mg \& 125 mg Pbo capsules.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Arm 1: Day 1: aprepitant 125 mg capsule; ondansetron 8 mg capsule prior to chemotherapy and 1 8mg capsule 12 hrs after first dose; dexamethasone 12 mg tablets + 2 dexamethasone Pbo tablets. Day 2: Aprepitant 80 mg capsule; Ondansetron 8 mg capsule every 12 hours Day 3: Aprepitant 80 mg capsule Ondansetron 8 mg capsule every 12 hours. Receives: Drug: aprepitant; Drug: Comparator: ondansetron; Drug: Comparator: dexamethasone; Drug: Comparator; Placebo (unspecified) |
| 2 | Other | Arm 2: Day 1: Aprepitant 125 mg Pbo capsule; Ondansetron 8 mg capsule prior to chemotherapy and 8 mg capsule 12 hours after first dose; Dexamethasone 20 mg tablets. Day 2: Aprepitant 80 mg Pbo capsule; Ondansetron 8 mg capsule every 12 hours; Day 3: Aprepitant 80 mg Pbo capsule; Ondansetron 8 mg capsule every 12 hours. 3 Day treatment period Optional cycle 2 is being offered to patients. Optional cycle 2 will substitute aprepitant with fosaprepitant dimeglumine 115 mg or Pbo on day 1. All other dosing regimen will remain the same as cycle 1. Receives: Drug: Comparator: ondansetron; Drug: Comparator: dexamethasone; Drug: Comparator: fosaprepitant dimeglumine; Drug: Comparator; Placebo (unspecified) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Reported No Vomiting
The number of patients who reported No Vomiting in the overall phase in Cycle
1
Measured: Overall phase (0-120 hours post initiation of MEC) in Cycle 1.
Secondary outcomes (1)
Number of Patients Who Reported Complete Response
The number of patients who reported Complete Response (no vomiting and no use of rescue medication) in the overall phase in Cycle 1.
Measured: Overall phase (0-120 hours post initiation of MEC) in Cycle 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2006 (estimated)
- Study start1 Jan 2007
- Primary completion28 Oct 2008
- Study completion19 Nov 2008
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 VomitingStudies 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
- 848 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337727
- Sponsor's protocol ID
- 0869-130
- Other IDs
- 2006_016
- Status last verified
- May 2017
- First submitted
- 14 Jun 2006
- Last updated
- 2 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php
Publications
Rapoport BL, Jordan K, Boice JA, Taylor A, Brown C, Hardwick JS, Carides A, Webb T, Schmoll HJ. Aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with a broad range of moderately emetogenic chemotherapies and tumor types: a randomized, double-blind study. Support Care Cancer. 2010 Apr;18(4):423-31. doi: 10.1007/s00520-009-0680-9. Epub 2009 Jul 1.
PubMed 19568773Rapoport BL. Efficacy of a triple antiemetic regimen with aprepitant for the prevention of chemotherapy-induced nausea and vomiting: effects of gender, age, and region. Curr Med Res Opin. 2014 Sep;30(9):1875-81. doi: 10.1185/03007995.2014.925866. Epub 2014 Jun 12.
PubMed 24911369Aapro MS, Schmoll HJ, Jahn F, Carides AD, Webb RT. Review of the efficacy of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in a range of tumor types. Cancer Treat Rev. 2013 Feb;39(1):113-7. doi: 10.1016/j.ctrv.2012.09.002. Epub 2012 Oct 11.
PubMed 23062719
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Moderately Emetogenic Chemotherapy (MEC)
- ClinicalTrials.gov ID
- NCT00337727
- Acronym / sponsor ID
- 0869-130
- Conditions
- Chemotherapy-Induced Nausea and Vomiting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 848 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 28 Oct 2008 (actual)
- Study completion
- 19 Nov 2008 (actual)
- First posted
- 16 Jun 2006 (estimated)
- Results
- Posted 6 Nov 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will test aprepitant for the prevention of CINV in patients receiving their initial cycle of Moderately Emetogenic Chemotherapy (MEC). Patients receiving more then one cycle of chemotherapy may opt to participate in an optional second cycle during which the patient will receive the same antiemetic regimen as cycle 1, except that an IV formulation of aprepitant will be given in place of the oral formulation on study day one. Study drug administration on subsequent days will be given orally as in cycle 1.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: aprepitant, Drug: Comparator: ondansetron, Drug: Comparator: dexamethasone, Drug: Comparator; Placebo (unspecified)Arm 1: Day 1: aprepitant 125 mg capsule; ondansetron 8 mg capsule prior to chemotherapy and 1 8mg capsule 12 hrs after first dose; dexamethasone 12 mg tablets + 2 dexamethasone Pbo tablets. Day 2: Aprepitant 80 mg capsule; Ondansetron 8 mg capsule every 12 hours Day 3: Aprepitant 80 mg capsule Ondansetron 8 mg capsule every 12 hours. |
| 2 | Other | Drug: Comparator: ondansetron, Drug: Comparator: dexamethasone, Drug: Comparator: fosaprepitant dimeglumine, Drug: Comparator; Placebo (unspecified)Arm 2: Day 1: Aprepitant 125 mg Pbo capsule; Ondansetron 8 mg capsule prior to chemotherapy and 8 mg capsule 12 hours after first dose; Dexamethasone 20 mg tablets. Day 2: Aprepitant 80 mg Pbo capsule; Ondansetron 8 mg capsule every 12 hours; Day 3: Aprepitant 80 mg Pbo capsule; Ondansetron 8 mg capsule every 12 hours. 3 Day treatment period Optional cycle 2 is being offered to patients. Optional cycle 2 will substitute aprepitant with fosaprepitant dimeglumine 115 mg or Pbo on day 1. All other dosing regimen will remain the same as cycle 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients will be naive to emetogenic chemotherapy with histologically or cytologically confirmed malignant disease scheduled to receive a single dose of moderately emetogenic chemotherapy on study day 1
- Karnofsky score of 60 or greater
Key exclusion criteria (6 listed)
- Patient is scheduled to receive any dose of cisplatin
- Patient will receive abdominal or pelvic radiation a week prior and up to 6 days after initiation of chemotherapy
- Any allergies to study drug or antiemetics
- Taking CYP3A4 substrates/prohibited medication
- Significant medical or mental conditions
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 |
|---|---|---|
| aprepitantAlso: MK0869aprepitant 125 mg capsule; aprepitant 80 mg capsule Three day treatment period. | Drug | 1 |
| Comparator: ondansetronAlso: Zofran®Ondansetron 8 mg capsule Three day treatment period. | Drug | 1, 2 |
| Comparator: dexamethasoneAlso: DEXAMETHASONE TABLETS USPdexamethasone 12 mg tablets; 20 mg tablets Three day treatment period. | Drug | 1, 2 |
| Comparator: fosaprepitant dimeglumineAlso: EMEND®fosaprepitant dimeglumine 115 mg | Drug | 2 |
| Comparator; Placebo (unspecified)dexamethasone 12mg Pbo tablets. | Drug | 1 |
| Comparator; Placebo (unspecified)Aprepitant 80 mg \& 125 mg Pbo capsules. | Drug | 2 |
Primary outcome
Number of Patients Who Reported No Vomiting
Time frame: Overall phase (0-120 hours post initiation of MEC) in Cycle 1.
The number of patients who reported No Vomiting in the overall phase in Cycle 1
1 secondary outcome
Number of Patients Who Reported Complete Response
Time frame: Overall phase (0-120 hours post initiation of MEC) in Cycle 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19568773Rapoport BL, Jordan K, Boice JA, Taylor A, Brown C, Hardwick JS, Carides A, Webb T, Schmoll HJ. Aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with a broad range of moderately emetogenic chemotherapies and tumor types: a randomized, double-blind study. Support Care Cancer. 2010 Apr;18(4):423-31. doi: 10.1007/s00520-009-0680-9. Epub 2009 Jul 1.
- Derived from this study: PubMed 24911369Rapoport BL. Efficacy of a triple antiemetic regimen with aprepitant for the prevention of chemotherapy-induced nausea and vomiting: effects of gender, age, and region. Curr Med Res Opin. 2014 Sep;30(9):1875-81. doi: 10.1185/03007995.2014.925866. Epub 2014 Jun 12.
- Derived from this study: PubMed 23062719Aapro MS, Schmoll HJ, Jahn F, Carides AD, Webb RT. Review of the efficacy of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in a range of tumor types. Cancer Treat Rev. 2013 Feb;39(1):113-7. doi: 10.1016/j.ctrv.2012.09.002. Epub 2012 Oct 11.
- Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
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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 Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing aprepitant, Comparator: ondansetron and Comparator: dexamethasone in people with Chemotherapy-Induced Nausea and Vomiting, 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 2 inclusion and 6 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 2 Jun 2017. 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 6 Nov 2009). 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?
Number of Patients Who Reported No Vomiting (time frame: Overall phase (0-120 hours post initiation of MEC) in Cycle 1.). 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 NCT00337727, 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 2 Jun 2017.