NauseaEarly Phase 1NCT00314743
Efficacy & Safety of the Oral Neurokinin-1 Antagonist, Aprepitant, in Combo With Ondansetron & Dexamethasone in Patients Undergoing Auto Peripheral Blood Stem Cell Transplantation
A Early Phase 1 study testing Ondansetron, Dexamethasone and Aprepitant in people with Nausea and Vomiting, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine the efficacy of aprepitant in preventing acute and delayed chemotherapy induced nausea and vomiting when administered in combination with intravenous or oral ondansetron and intravenous or oral dexamethasone in the autologous transplant setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Ondansetron, Dexamethasone and Aprepitant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Dec 2008
- Phase
- Early Phase 1
- 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
- Male or female patients 18 years of age or older
- Patients deemed eligible to undergo autologous bone marrow or peripheral stem cell transplant therapy per usual transplant inclusion and exclusion criteria
- Patients with Non-Hodgkins Lymphoma, Hodgkins Lymphoma or Multiple Myeloma or Amyloidosis
- Written informed consent
Who cannot join
- Nausea at baseline
- Chronic use of other antiemetic agent(s)
- Gastrointestinal obstruction or active peptic ulcer
- Radiation therapy to pelvis or abdomen within 1 week before or after study day 1
- Allogeneic stem cell transplant recipient
- Aspartate transaminase (AST) > 3x upper limit of normal (ULN)
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- Alanine transaminase (ALT) > 3x ULN
- Bilirubin > 3x ULN
- Alkaline phosphatase > 3x ULN
- Creatinine > 2
- Documented hypersensitivity to any component of study regimen
- Pregnant or lactating women
- Participating in a clinical trial which involves other investigational agent(s)
- Patients taking any of the following medications at time of study day 1: warfarin, oral contraceptives (except for the administration of stopping menses), tolbutamide, phenytoin, midazolam, ketoconazole, rifampin, paroxetine, and/or diltiazem.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Study Evaluating the Efficacy and Safety of the Oral Neurokinin-1 Antagonist, Aprepitant, in Combination With Ondansetron and Dexamethasone in Patients Undergoing Autologous Peripheral Blood Stem Cell Transplantation
The purpose of this study is to determine the efficacy of aprepitant in preventing acute and delayed chemotherapy induced nausea and vomiting when administered in combination with intravenous or oral ondansetron and intravenous or oral dexamethasone in the autologous transplant setting.
- Being tested
- Ondansetron, Dexamethasone, Aprepitant
- Keywords
- Patients with Non-Hodgkins Lymphoma or Multiple Myeloma
- Medical subject headings
- Nausea, Vomiting, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Also called Zofran
DexamethasoneDrug
AprepitantDrug
Also called Emend
| Study group | Role | What they receive |
|---|---|---|
| Control (No aprepitant) | Active comparator | Regimen #1 (BEAM; NHL and HL)
Carmustine 300 mg/m2 IV on day -7 (premedicate with ondansetron 32 mg IV and dexamethasone 20 mg IV)
Etoposide 100 mg/m2 IV Q 12 hours x 8 doses on days -6 to -3 (premedicate first daily dose ondansetron 32 mg IV and dexamethasone 20 mg IV)
Cytarabine 100 mg/m2 IV Q 12 hours x 8 doses on days -6 and -3 (no additional premedication)
Melphalan 140 mg/m2 IV on day -2 (premedicate with ondansetron 32 mg IV and dexamethasone 20 mg IV)
Regimen #2 (MM and Amyloidosis)
Melphalan 100 mg/m2 IV on days -3 and -2 (premedicate each dose with ondansetron 32 mg IV and dexamethasone 20 mg IV) Receives: Drug: Ondansetron; Drug: Dexamethasone |
| Experimental (with aprepitant) | Experimental | Aprepitant 125 mg PO will be given 30 minutes prior to the first dose of chemotherapy followed by Aprepitant 80 mg PO QD for the remainder of chemotherapy and continuing for a total of 2 days after completing the regimen.
Regimen #1 (BEAM; NHL and HL)
Carmustine 300 mg/m2 IV on day -7 (premedicate with ondansetron 32 mg IV and dexamethasone 10 mg IV)
Etoposide 100 mg/m2 IV Q 12 hours x 8 doses on days -6 to -3 (premedicate first daily dose ondansetron 32 mg IV and dexamethasone 10 mg IV)
Cytarabine 100 mg/m2 IV Q 12 hours x 8 doses on days -6 and -3 (no additional premedication)
Melphalan 140 mg/m2 IV on day -2 (premedicate with ondansetron 32 mg IV and dexamethasone 10 mg IV)
Regimen #2 (MM and Amyloidosis)
Melphalan 100 mg/m2 IV on days -3 and -2 (premedicate each dose with ondansetron 32 mg IV and dexamethasone 10 mg IV) Receives: Drug: Ondansetron; Drug: Dexamethasone; Drug: Aprepitant |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the efficacy of aprepitant in preventing acute & delayed chemotherapy induced nausea & vomiting when administered in combination with intravenous or oral ondansetron & intravenous or oral dexamethasone in the autologous transplant setting.
Measured: Day 30
Secondary outcomes (4)
To measure the the severity, frequency, and duration of chemotherapy induced nausea and vomiting in patients receiving aprepitant and compare these results to a control group, not receiving aprepitant.
Measured: Day 30
To measure the need for breakthrough antiemetics in patients receiving aprepitant and compare these results to the control group
Measured: Day 30
To assess the incidence of complications associated with chemotherapy induced nausea and vomiting in patients receiving aprepitant and compare these results to the control group.
Measured: Day 30
To assess the safety of aprepitant in combination with ondansetron and dexamethasone in the autologous transplant setting.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2006 (estimated)
- Study startOct 2005
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John F DiPersio, M.D., Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00314743
- Sponsor's protocol ID
- 03-1192
- Status last verified
- May 2013
- First submitted
- 12 Apr 2006
- Last updated
- 24 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating the Efficacy and Safety of the Oral Neurokinin-1 Antagonist, Aprepitant, in Combination With Ondansetron and Dexamethasone in Patients Undergoing Autologous Peripheral Blood Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00314743
- Acronym / sponsor ID
- 03-1192
- Keywords
- Patients with Non-Hodgkins Lymphoma or Multiple Myeloma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 14 Apr 2006 (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.
The purpose of this study is to determine the efficacy of aprepitant in preventing acute and delayed chemotherapy induced nausea and vomiting when administered in combination with intravenous or oral ondansetron and intravenous or oral dexamethasone in the autologous transplant setting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (No aprepitant) | Active comparator | Drug: Ondansetron, Drug: DexamethasoneRegimen #1 (BEAM; NHL and HL) Carmustine 300 mg/m2 IV on day -7 (premedicate with ondansetron 32 mg IV and dexamethasone 20 mg IV) Etoposide 100 mg/m2 IV Q 12 hours x 8 doses on days -6 to -3 (premedicate first daily dose ondansetron 32 mg IV and dexamethasone 20 mg IV) Cytarabine 100 mg/m2 IV Q 12 hours x 8 doses on days -6 and -3 (no additional premedication) Melphalan 140 mg/m2 IV on day -2 (premedicate with ondansetron 32 mg IV and dexamethasone 20 mg IV) Regimen #2 (MM and Amyloidosis) Melphalan 100 mg/m2 IV on days -3 and -2 (premedicate each dose with ondansetron 32 mg IV and dexamethasone 20 mg IV) |
| Experimental (with aprepitant) | Experimental | Drug: Ondansetron, Drug: Dexamethasone, Drug: AprepitantAprepitant 125 mg PO will be given 30 minutes prior to the first dose of chemotherapy followed by Aprepitant 80 mg PO QD for the remainder of chemotherapy and continuing for a total of 2 days after completing the regimen. Regimen #1 (BEAM; NHL and HL) Carmustine 300 mg/m2 IV on day -7 (premedicate with ondansetron 32 mg IV and dexamethasone 10 mg IV) Etoposide 100 mg/m2 IV Q 12 hours x 8 doses on days -6 to -3 (premedicate first daily dose ondansetron 32 mg IV and dexamethasone 10 mg IV) Cytarabine 100 mg/m2 IV Q 12 hours x 8 doses on days -6 and -3 (no additional premedication) Melphalan 140 mg/m2 IV on day -2 (premedicate with ondansetron 32 mg IV and dexamethasone 10 mg IV) Regimen #2 (MM and Amyloidosis) Melphalan 100 mg/m2 IV on days -3 and -2 (premedicate each dose with ondansetron 32 mg IV and dexamethasone 10 mg IV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients 18 years of age or older
- Patients deemed eligible to undergo autologous bone marrow or peripheral stem cell transplant therapy per usual transplant inclusion and exclusion criteria
- Patients with Non-Hodgkins Lymphoma, Hodgkins Lymphoma or Multiple Myeloma or Amyloidosis
- Written informed consent
Key exclusion criteria (14 listed)
- Nausea at baseline
- Chronic use of other antiemetic agent(s)
- Gastrointestinal obstruction or active peptic ulcer
- Radiation therapy to pelvis or abdomen within 1 week before or after study day 1
- Allogeneic stem cell transplant recipient
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 |
|---|---|---|
| OndansetronAlso: Zofran | Drug | Control (No aprepitant), Experimental (with aprepitant) |
| Dexamethasone | Drug | Control (No aprepitant), Experimental (with aprepitant) |
| AprepitantAlso: Emend | Drug | Experimental (with aprepitant) |
Primary outcome
To determine the efficacy of aprepitant in preventing acute & delayed chemotherapy induced nausea & vomiting when administered in combination with intravenous or oral ondansetron & intravenous or oral dexamethasone in the autologous transplant setting.
Time frame: Day 30
4 secondary outcomes
To measure the the severity, frequency, and duration of chemotherapy induced nausea and vomiting in patients receiving aprepitant and compare these results to a control group, not receiving aprepitant.
Time frame: Day 30
To measure the need for breakthrough antiemetics in patients receiving aprepitant and compare these results to the control group
Time frame: Day 30
To assess the incidence of complications associated with chemotherapy induced nausea and vomiting in patients receiving aprepitant and compare these results to the control group.
Time frame: Day 30
To assess the safety of aprepitant in combination with ondansetron and dexamethasone in the autologous transplant setting.
Time frame: Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2013.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
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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.
John F DiPersio, M.D., Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ondansetron, Dexamethasone and Aprepitant in people with Nausea and Vomiting, run by Washington University School of Medicine at 1 site in United States.
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 4 inclusion and 14 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 24 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the efficacy of aprepitant in preventing acute & delayed chemotherapy induced nausea & vomiting when administered in combination with intravenous or oral ondansetron & intravenous or oral dexamethasone in the autologous transplant setting. (time frame: Day 30). 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 24 May 2013.