Chemo-radiation Induced Nausea and VomitingPhase 2NCT02991456
Rolapitant as an Antiemetic in Malignant Glioma Patients Receiving Radiotherapy and Temozolomide
A Phase 2 study testing Rolapitant and Ondansetron in people with Chemo-radiation Induced Nausea and Vomiting, run by Duke University at 1 site in United States.
Trial summary
The purpose of this phase 2 study is to assess the efficacy and patient satisfaction of oral rolapitant plus ondansetron vs. oral ondansetron monotherapy in malignant glioma (MG) patients receiving standard of care radiation (RT) and temozolomide (TMZ) therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemo-radiation Induced Nausea and Vomiting
- What is being tested?
- Rolapitant and Ondansetron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2017to 20 Jun 2022
- Phase
- Phase 2
- 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 must have histologically-confirmed, newly-diagnosed malignant glioma (glioblastoma, gliosarcoma, anaplastic astrocytoma, anaplastic oligoastrocytoma, anaplastic pleomorphic xanthoastrocytoma, or anaplastic oligodendroglioma) and are scheduled to receive radiotherapy (for a total of 54-60 Gy) and concomitant daily temozolomide therapy (at a dose of 75 mg/m^2 for one complete 6-week cycle).
- Age ≥ 18 years
- Karnofsky ≥ 60% or ECOG 0-2
- Hematocrit >29%, Absolute Neutrophil Count >1,000 cells/mm^3, platelets >100,000 cells/mm^3
- Serum creatinine <1.4 mg/dl, bilirubin <1.5 times upper limit of normal (ULN)
- Aspartate aminotransferase (AST) ≤ 2.5 x ULN. For subjects with known liver metastases ≤ 5 x ULN, and alanine aminotransferase (ALT) ≤ 2.5 x ULN. For subjects with known liver metastases ≤ 5 x ULN
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- For patients on higher than physiological level of corticosteroids, they must have been on a stable dose for 1 week prior to initiating study drug, and the dose should not be escalated over entry dose level, if clinically possible
- Ability and willingness to give informed consent
- Female patients of childbearing potential must have a negative pregnancy test at Screening
- Female patients of childbearing potential must agree to use an acceptable method of birth control from the signing of informed consent and to continue its use during the study and for at least 90 days after the final dose
- Male patients must agree to use an acceptable form of birth control from study Day 1 through at least 90 days after the final dose
Who cannot join
- Co-medications that may interact with rolapitant as reviewed by Duke Preston Robert Tisch Brain Tumor investigator pharmacist.
- Co-medications that are contraindicated in patients on rolapitant including pimozide, thioridazine, carbamazepine, colchicine, dabigatran (Pradaxa), edoxaban (Savaysa), fosphenytoin, metoprolol, phenobarbital, phenytoin, primidone, and warfarin
- Inability or unwillingness to cooperate with the study procedures
- Prophylactic medication for the prevention of nausea and vomiting 24 hours prior to the start of radiation therapy through the full course of radiation therapy is prohibited, with the exception of the study drug. Corticosteroids will be allowed for treatment of cerebral swelling
- Previous participation in any clinical trial involving rolapitant
- Any vomiting, retching, dry heaves, or clinically significant nausea (i.e., NCI Common Toxicity Criteria version 4.0 grade 2-4 nausea) caused by any etiology in the 24 hrs. preceding day 1 of the study intervention (ondansetron or ondansetron with rolapitant) as scheduled to begin on day 1 of radiation and chemotherapy. Or a patient who has a history of anticipatory nausea and vomiting.
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- Ongoing vomiting from any organic etiology
- Received rolapitant within 21 days prior to study enrollment
- Prior cancer chemotherapy or radiotherapy
- Any current treatment, medical history, or uncontrolled condition, other than malignancy, (e.g., alcoholism or signs of alcohol abuse, seizure disorder, medical or psychiatric condition) that, in the opinion of the investigator, would confound the results of the study or pose any unwarranted risk in administering study drug to the subject
- Patient has a known hypersensitivity to the administration of rolapitant or its excipients
- Patient has a history of severe renal or hepatic impairment, severe bone marrow suppression, or systemic infection
- Patient is a woman with a positive serum pregnancy test at Screening, is pregnant, breast-feeding, or is planning to conceive children within the projected duration of the study treatment
- Patient has taken the following agents within the last 48 hours prior to the start of treatment with study drug:
- 5-HT3 antagonists (ondansetron, granisetron, dolasetron, tropisetron, etc.).
- Benzamides (metoclopramide, alizapride, etc.)
- Domperidone
- Cannabinoids
- Natural Killer (NK)-1 antagonist (aprepitant)
- Benzodiazepines (lorazepam, alprazolam, etc.)
- herbal medications or preparations in doses designed to ameliorate nausea or emesis
- Patient has taken phenothiazines (prochlorperazine, fluphenazine, perphenazine, thiethylperazine, chlorpromazine, etc.) for any indication within the last 48 hours prior to the start of treatment with study drug
- Palonosetron is not permitted within 7 days prior to administration of investigational product
- Patient must not have been dosed with a test drug or blinded study drug in another investigational study within 30 days or 5 half-lives of the biologic activity of the test drug, whichever is longer, before the time of first study dose
- Patient who is receiving investigational agent(s) as part of another clinical study at the time of screening or who anticipates receiving investigational agent(s) during their scheduled radiotherapy and concomitant daily temozolomide therapy (Any exception to this criteria will be noted in a study Memo to File)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Preston Robert Tisch Brain Tumor Center at Duke
Durham, North Carolina, 27710
About this study
Official title: Phase II Randomized Study to Evaluate Efficacy, Patient Satisfaction, and Compliance of the Oral Combination of Rolapitant (Varubi®) Plus Ondansetron vs. Ondansetron Monotherapy in Malignant Glioma Patients Receiving Radiotherapy (RT) and Concomitant Temozolomide
The purpose of this phase 2 study is to assess the efficacy and patient satisfaction of oral rolapitant plus ondansetron vs. oral ondansetron monotherapy in malignant glioma (MG) patients receiving standard of care radiation (RT) and temozolomide (TMZ) therapy. This is a randomized phase 2 trial of rolapitant plus ondansetron vs. ondansetron monotherapy for the prevention of chemo-radiation induced nausea and vomiting in primary MG subjects receiving RT and concomitant multi-dose TMZ.
Read the detailed description
All eligible subjects should receive a planned total dose of 54-60 gray (GY) of radiation and 75 mg/m2 of TMZ daily for a total of six weeks. Patients will be randomized to receive one of two antiemetic treatment sequences: sequence A that involves administration of ondansetron alone for 3 weeks followed by a single dose of rolapitant (day 22) plus daily ondansetron for 3 weeks or sequence B that involves a single dose of rolapitant (day 1) plus daily ondansetron for 3 weeks followed by 3 weeks of daily ondansetron alone. The study has one primary endpoint: complete response (CR) rate. Participation in this study may result in reduced chemo-radiation induced nausea and vomiting, however, risks include the common side effects of rolapitant including decreased appetite, neutropenia, dizziness, dyspepsia, urinary tract infection, stomatitis, and anemia.
- Being tested
- Rolapitant, Ondansetron
- Keywords
- malignant glioma, temozolomide, temodar, radiation, emesis, nausea, vomiting, chemotherapy, Affronti, Peters, 00076418
- Medical subject headings
- Vomiting, Glioma, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RolapitantDrug
Also called Varubi
single 180 mg dose by mouth
OndansetronDrug
Also called Zofran
8 mg by mouth daily
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Active comparator | Daily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks. Receives: Drug: Rolapitant; Drug: Ondansetron |
| Sequence B | Active comparator | Single dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks. Receives: Drug: Rolapitant; Drug: Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR) Rate as Measured by Antiemesis Tool (MAT)
The Complete Response rate is defined as the proportion of participants with no emetic episode or the use of rescue medication during the first two weeks of radiation therapy and concomitant Temozolomide. The Complete Response rate will be assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).
Measured: Weeks 1 and 2
Complete Response (CR) Rate as Measured by MAT With Supplemental Nurses Notes
The Complete Response rate is defined as the proportion of participants with no emetic episode or the use of rescue medication during the first two weeks of radiation therapy and concomitant Temozolomide. The Complete Response rate will be assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) MAT and nurse notes if MATs are missing.
Measured: Weeks 1 and 2
Secondary outcomes (16)
Number of Participants Preferring Rolapitant in Combination With Ondansetron Versus Ondansetron Alone
The number of participants who prefer rolapitant plus ondansetron over ondansetron alone, as determined by response to the question with "Which nausea medication regimen was I most satisfied with?"
Measured: Weeks 1-6
Week 3 Patient Satisfaction: Effectiveness
Mean effectiveness scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The effectiveness subscale score was computed from the 3 items corresponding to effectiveness. The resulting effectiveness score is measured from 0-100 with higher scores corresponding to higher effectiveness.
Measured: Weeks 1-3
Week 3 Patient Satisfaction: Convenience
Mean convenience scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The convenience subscale score was computed from the 3 items corresponding to convenience. The resulting convenience score is measured from 0-100 with higher scores corresponding to higher convenience.
Measured: Weeks 1-3
Week 3 Patient Satisfaction: Overall Satisfaction
Mean overall satisfaction scores at week 3 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The overall satisfaction subscale score was computed from the 3 items corresponding to overall satisfaction. The resulting overall satisfaction score is measured from 0-100 with higher scores corresponding to higher overall satisfaction.
Measured: Weeks 1-3
Week 6 Patient Satisfaction: Effectiveness
Mean effectiveness scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The effectiveness subscale score was computed by summing the 3 items corresponding to effectiveness. The resulting effectiveness score is measured from 0-100 with higher scores corresponding to higher effectiveness.
Measured: Weeks 4-6
Week 6 Patient Satisfaction: Convenience
Mean convenience scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The convenience subscale score was computed from the 3 items corresponding to convenience. The resulting convenience score is measured from 0-100 with higher scores corresponding to higher convenience.
Measured: Weeks 4-6
Week 6 Patient Satisfaction: Overall Satisfaction
Mean overall satisfaction scores at week 6 using the 9-item Treatment Satisfaction Questionnaire for Medication (TSQM-9) patient satisfaction survey. The overall satisfaction subscale score was computed from the 3 items corresponding to overall satisfaction. The resulting overall satisfaction score is measured from 0-100 with higher scores corresponding to higher overall satisfaction.
Measured: Weeks 4-6
Chemoradiation-induced Nausea (cRIN) Rate Over First Two Weeks
The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).
Measured: Weeks 1 and 2
Chemoradiation-induced Nausea (cRIN) Rate Over First Two Weeks and Supplemented by Nurses Notes
The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) and nurses notes if MATs were missing.
Measured: Weeks 1 and 2
Chemoradiation-induced Vomiting (cRIV) Rate Over First Two Weeks
The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).
Measured: Weeks 1 and 2
Chemoradiation-induced Vomiting (cRIV) Rate Over First Two Weeks With Supplemental Nurses Notes
The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) and nurse notes if MATS are missing.
Measured: Weeks 1 and 2
Chemoradiation-induced Nausea (cRIN) Rate Over All Six Weeks
The cRIN-CR rate is defined as the proportion of participants who did not use rescue medication for nausea. The cRIN-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).
Measured: Weeks 1-6
Chemoradiation-induced Vomiting (cRIV) Rate Over All Six Weeks
The cRIV-CR rate is defined as the proportion of participants without use of rescue medication for vomiting. The cRIV-CR rates were assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).
Measured: Weeks 1-6
Ondansetron Medication Compliance Weeks 1-3
Percentage of participants who adhered to ondansetron treatment for more than 21 days during weeks 1-3.
Measured: Weeks 1-3
Ondansetron Medication Compliance Weeks 4-6
Percentage of participants who adhered to ondansetron treatment for more than 21 days during weeks 4-6.
Measured: Weeks 4-6
Proportion of Participants With Grade 3, 4 or 5 Treatment-related Adverse Events
The proportion of participants with grade 3, 4 or 5 adverse events (severe, life-threatening, or fatal) possibly, probably or definitely related to administration of Rolapitant or Ondansetron. Adverse events will be collected from start of treatment through the end of the two-week period following chemoradiation (or until 30 days after the last dose of rolapitant is given in Sequence A). CTCAE version 4 was used to grade adverse events.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study start9 Oct 2017
- Primary completion9 May 2022
- Study completion20 Jun 2022
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.
- Other trials for Chemo-radiation Induced Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary Lou Affronti, DNP, RN, ANP, MHSc, Principal investigator, The Preston Robert Tisch Brain Tumor Center at Duke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991456
- Sponsor's protocol ID
- Pro00076418
- Status last verified
- Jul 2023
- First submitted
- 9 Dec 2016
- Last updated
- 11 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Study to Evaluate Efficacy, Patient Satisfaction, and Compliance of the Oral Combination of Rolapitant (Varubi®) Plus Ondansetron vs. Ondansetron Monotherapy in Malignant Glioma Patients Receiving Radiotherapy (RT) and Concomitant Temozolomide
- ClinicalTrials.gov ID
- NCT02991456
- Acronym / sponsor ID
- Pro00076418
- Keywords
- malignant glioma, temozolomide, temodar, radiation, emesis, nausea, vomiting, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 9 May 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 13 Dec 2016 (estimated)
- Results
- Posted 11 Jul 2023
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 phase 2 study is to assess the efficacy and patient satisfaction of oral rolapitant plus ondansetron vs. oral ondansetron monotherapy in malignant glioma (MG) patients receiving standard of care radiation (RT) and temozolomide (TMZ) therapy. This is a randomized phase 2 trial of rolapitant plus ondansetron vs. ondansetron monotherapy for the prevention of chemo-radiation induced nausea and vomiting in primary MG subjects receiving RT and concomitant multi-dose TMZ.
Detailed description
All eligible subjects should receive a planned total dose of 54-60 gray (GY) of radiation and 75 mg/m2 of TMZ daily for a total of six weeks. Patients will be randomized to receive one of two antiemetic treatment sequences: sequence A that involves administration of ondansetron alone for 3 weeks followed by a single dose of rolapitant (day 22) plus daily ondansetron for 3 weeks or sequence B that involves a single dose of rolapitant (day 1) plus daily ondansetron for 3 weeks followed by 3 weeks of daily ondansetron alone. The study has one primary endpoint: complete response (CR) rate. Participation in this study may result in reduced chemo-radiation induced nausea and vomiting, however, risks include the common side effects of rolapitant including decreased appetite, neutropenia, dizziness, dyspepsia, urinary tract infection, stomatitis, and anemia.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Active comparator | Drug: Rolapitant, Drug: OndansetronDaily ondansetron alone for 3 weeks, followed by the use of rolapitant (one dose on day 22) plus continued daily ondansetron for 3 weeks. |
| Sequence B | Active comparator | Drug: Rolapitant, Drug: OndansetronSingle dose of rolapitant (one dose on day 1) plus daily ondansetron for 3 weeks, followed by daily ondansetron alone for 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have histologically-confirmed, newly-diagnosed malignant glioma (glioblastoma, gliosarcoma, anaplastic astrocytoma, anaplastic oligoastrocytoma, anaplastic pleomorphic xanthoastrocytoma, or anaplastic oligodendroglioma) and are scheduled to receive radiotherapy (for a total of 54-60 Gy) and concomitant daily temozolomide therapy (at a dose of 75 mg/m^2 for one complete 6-week cycle).
- Age ≥ 18 years
- Karnofsky ≥ 60% or ECOG 0-2
- Hematocrit >29%, Absolute Neutrophil Count >1,000 cells/mm^3, platelets >100,000 cells/mm^3
- Serum creatinine <1.4 mg/dl, bilirubin <1.5 times upper limit of normal (ULN)
Key exclusion criteria (25 listed)
- Co-medications that may interact with rolapitant as reviewed by Duke Preston Robert Tisch Brain Tumor investigator pharmacist.
- Co-medications that are contraindicated in patients on rolapitant including pimozide, thioridazine, carbamazepine, colchicine, dabigatran (Pradaxa), edoxaban (Savaysa), fosphenytoin, metoprolol, phenobarbital, phenytoin, primidone, and warfarin
- Inability or unwillingness to cooperate with the study procedures
- Prophylactic medication for the prevention of nausea and vomiting 24 hours prior to the start of radiation therapy through the full course of radiation therapy is prohibited, with the exception of the study drug. Corticosteroids will be allowed for treatment of cerebral swelling
- Previous participation in any clinical trial involving rolapitant
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 |
|---|---|---|
| RolapitantAlso: Varubisingle 180 mg dose by mouth | Drug | Sequence A, Sequence B |
| OndansetronAlso: Zofran8 mg by mouth daily | Drug | Sequence A, Sequence B |
Primary outcome
Complete Response (CR) Rate as Measured by Antiemesis Tool (MAT)
Time frame: Weeks 1 and 2
The Complete Response rate is defined as the proportion of participants with no emetic episode or the use of rescue medication during the first two weeks of radiation therapy and concomitant Temozolomide. The Complete Response rate will be assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT).
Complete Response (CR) Rate as Measured by MAT With Supplemental Nurses Notes
Time frame: Weeks 1 and 2
The Complete Response rate is defined as the proportion of participants with no emetic episode or the use of rescue medication during the first two weeks of radiation therapy and concomitant Temozolomide. The Complete Response rate will be assessed via the modified Multinational Association of Supportive Care in Cancer (MASCC) MAT and nurse notes if MATs are missing.
16 secondary outcomes
Number of Participants Preferring Rolapitant in Combination With Ondansetron Versus Ondansetron Alone
Time frame: Weeks 1-6
Week 3 Patient Satisfaction: Effectiveness
Time frame: Weeks 1-3
Week 3 Patient Satisfaction: Convenience
Time frame: Weeks 1-3
Week 3 Patient Satisfaction: Overall Satisfaction
Time frame: Weeks 1-3
Week 6 Patient Satisfaction: Effectiveness
Time frame: Weeks 4-6
Week 6 Patient Satisfaction: Convenience
Time frame: Weeks 4-6
Week 6 Patient Satisfaction: Overall Satisfaction
Time frame: Weeks 4-6
Chemoradiation-induced Nausea (cRIN) Rate Over First Two Weeks
Time frame: Weeks 1 and 2
Chemoradiation-induced Nausea (cRIN) Rate Over First Two Weeks and Supplemented by Nurses Notes
Time frame: Weeks 1 and 2
Chemoradiation-induced Vomiting (cRIV) Rate Over First Two Weeks
Time frame: Weeks 1 and 2
Chemoradiation-induced Vomiting (cRIV) Rate Over First Two Weeks With Supplemental Nurses Notes
Time frame: Weeks 1 and 2
Chemoradiation-induced Nausea (cRIN) Rate Over All Six Weeks
Time frame: Weeks 1-6
Chemoradiation-induced Vomiting (cRIV) Rate Over All Six Weeks
Time frame: Weeks 1-6
Ondansetron Medication Compliance Weeks 1-3
Time frame: Weeks 1-3
Ondansetron Medication Compliance Weeks 4-6
Time frame: Weeks 4-6
Proportion of Participants With Grade 3, 4 or 5 Treatment-related Adverse Events
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The Preston Robert Tisch Brain Tumor Center at DukeLink 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.
Mary Lou Affronti, DNP, RN, ANP, MHSc principal investigator
The Preston Robert Tisch Brain Tumor Center at Duke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rolapitant and Ondansetron in people with Chemo-radiation Induced Nausea and Vomiting, run by Duke University 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 11 inclusion and 25 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 11 Jul 2023. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 11 Jul 2023). 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?
Complete Response (CR) Rate as Measured by Antiemesis Tool (MAT) (time frame: Weeks 1 and 2). The study lists 2 primary outcomes in all. 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 11 Jul 2023.