Malignant NeoplasmPhase 2NCT03097588
Netupitant and Palonosetron Hydrochloride in Preventing Chemotherapy Induced Nausea and Vomiting in Patients With Cancer Undergoing BEAM Conditioning Regimen Before Stem Cell Transplant
A Phase 2 study testing Netupitant, Palonosetron Hydrochloride and Questionnaire Administration in people with Malignant Neoplasm, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This phase II trial studies how well netupitant and palonosetron hydrochloride work in preventing chemotherapy induced nausea and vomiting in patients with cancer undergoing BEAM conditioning regimen before stem cell transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Netupitant, Palonosetron Hydrochloride and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2017to 20 Mar 2020
- 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
- Subjects must be undergoing autologous or allogeneic hematopoietic stem cell transplant (HSCT) with the BEAM conditioning regimen prior to HSCT
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 or Karnofsky Performance Score >= 60%
- Able to swallow oral medications
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Subjects with known hypersensitivity or other allergic reactions attributed to compounds of similar biologic composition to netupitant, palonosetron, dexamethasone, or other agents used in the study
- Subjects who are receiving any other investigational agents or have received another investigational drug in the last 30 days
- Subjects who have had emesis or required antiemetics in the 48 hours prior to starting the BEAM conditioning regimen; patients required to take antipsychotics, appetite stimulants, or other medications with antiemetic effects will also be excluded if those medications cannot be replaced by therapeutic equivalents
- Female subjects who are pregnant, have a positive serum human chorionic gonadotrophin (hCG), or are lactating and intend to breastfeed a child; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with NEPA
- Human immunodeficiency virus (HIV)-positive subjects on combination antiretroviral therapy are ineligible
- Subjects who have taken a neurokinin antagonist within 14 days prior to beginning the BEAM regimen
Show all 16Show fewer
- Subjects who have a serum creatinine > 2 x upper limit of normal (ULN)
- Subjects with severe renal failure or end stage renal disease (estimated GFR [glomerular filtration rate] of < 30 mL/min) as estimated by the Cockcroft-Gault formula
- Subjects with severe hepatic insufficiency (Child Pugh score > 9)
- Subjects who have been reported > 5 alcoholic drinks daily for the last year
- Subjects who have concurrent illness requiring systemic corticosteroid use other than the planned dexamethasone during conditioning therapy
- Subjects with gastrointestinal conditions that might result in malabsorption of the study drug
- Subjects with a history of anxiety-induced ("anticipatory") nausea and vomiting
- Subjects on strong CYP 3A4 inducers or inhibitors who are unable to have those agents replaced with clinical alternatives prior to beginning the study; length of washout period will be 7 days; notably, in the case of allogeneic transplant recipients requiring cyclosporine or tacrolimus, no empiric dose adjustments will be required due to close level monitoring and adjustments, that are standard in Oregon Health \& Science University (OHSU) protocols
- Subjects unable to discontinue benzodiazepines as antiemetics will not be allowed; additional antiemetics will be allowed for rescue but not for prophylaxis
- Subjects with personal or family history of QT prolongation, uncorrected electrolyte abnormalities, congestive heart failure, bradyarrhythmia, conduction disturbances and those taking antiarrhythmic medicinal products or other medicinal products that lead to QT prolongation or electrolyte abnormalities; relevant information will be collected as part of subject medical history
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: A Phase II Clinical Trial of NEPA (Netupitant/Palonosetron) for Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Patient Receiving the BEAM Conditioning Regimen Prior to Hematopoietic Cell Transplantation (HSCT)
This phase II trial studies how well netupitant and palonosetron hydrochloride work in preventing chemotherapy induced nausea and vomiting in patients with cancer undergoing BEAM conditioning regimen before stem cell transplant. Chemotherapy, such as carmustine, cytarabine, etoposide, and melphalan (BEAM), makes people feel sick to their stomach and causes vomiting. Netupitant and palonosetron hydrochloride may reduce the nausea and vomiting caused by the BEAM treatment.
Read the detailed description
PRIMARY OBJECTIVES:
- To assess the efficacy of netupitant and palonosetron hydrochloride (NEPA) to prevent nausea and vomiting both during and after a highly emetogenic (BEAM) conditioning regimen for hematopoietic stem cell transplantation (HSCT).
SECONDARY OBJECTIVES:
- To differentiate response to NEPA over different phases of chemotherapy-induced nausea.
OUTLINE:
Within 60 minutes before standard of care BEAM treatment, patients receive netupitant and palonosetron hydrochloride orally (PO) on days 1, 3, and 6.
After completion of study treatment, patients are followed up at 14 days.
- Conditions
- Malignant Neoplasm
- Being tested
- Netupitant, Palonosetron Hydrochloride, Questionnaire Administration
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NetupitantDrug
Also called CID6451149, D05152, RO 67-3189/000
300 mg, Given PO, QD
Palonosetron HydrochlorideDrug
Also called Aloxi, RS 25259-197
0.5 mg, Given PO, QD
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (NEPA) | Experimental | Within 60 minutes before standard of care BEAM treatment, patients receive netupitant and palonosetron hydrochloride PO on days 1, 3, and 6.
Netupitant: 300 mg, QD, Given PO Palonosetron Hydrochloride: 0.5 mg, QD, Given PO Questionnaire Administration: Ancillary studies Receives: Drug: Netupitant; Drug: Palonosetron Hydrochloride; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR) Defined as no Emesis and no Rescue Therapy
Number of subjects that reached a complete response (CR), defined as having no emesis and no rescue therapy.
Measured: Up to 5 days post chemotherapy
Secondary outcomes (3)
CR (Acute Phase)
Number of subjects that reached a complete response (CR), defined as having no emesis and no rescue therapy from 0 to 144 hours (acute phase) of the study drug administration.
Measured: Up to 144 hours post-study drug administration on day 1
CR (Delayed Phase)
Number of subjects that reached a complete response (CR), defined as having no emesis and no rescue therapy from 145 hours up to 264 hours (delayed phase) of the study drug administration.
Measured: From 145 hours up to 264 hours post-study drug administration on day 1
Complete Protection (CP) Rate Defined as CR Plus no Nausea
Number of subjects that reached a complete response (CR), defined as having no emesis and no rescue therapy from 0 to 264 hours of the study drug administration.
Measured: Up to 264 hours post-study drug administration on day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start27 Apr 2017
- Primary completion20 Feb 2020
- Study completion20 Mar 2020
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 Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinn Therapeutics (U.S.), Inc, Oregon Health and Science University
- Responsible party
- Principal investigator, Joseph Bubalo, OHSU Knight Cancer Institute
- Investigators
- Joseph Bubalo, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097588
- Sponsor's protocol ID
- STUDY00016288
- Other IDs
- NCI-2017-00548, STUDY00016288
- Status last verified
- Jun 2021
- First submitted
- 27 Mar 2017
- Last updated
- 12 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial of NEPA (Netupitant/Palonosetron) for Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) in Patient Receiving the BEAM Conditioning Regimen Prior to Hematopoietic Cell Transplantation (HSCT)
- ClinicalTrials.gov ID
- NCT03097588
- Acronym / sponsor ID
- STUDY00016288
- Conditions
- Malignant Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Helsinn Therapeutics (U.S.), Inc, Oregon Health and Science University
- Study start
- 27 Apr 2017 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 31 Mar 2017 (actual)
- Results
- Posted 3 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well netupitant and palonosetron hydrochloride work in preventing chemotherapy induced nausea and vomiting in patients with cancer undergoing BEAM conditioning regimen before stem cell transplant. Chemotherapy, such as carmustine, cytarabine, etoposide, and melphalan (BEAM), makes people feel sick to their stomach and causes vomiting. Netupitant and palonosetron hydrochloride may reduce the nausea and vomiting caused by the BEAM treatment.
Detailed description
PRIMARY OBJECTIVES:
- To assess the efficacy of netupitant and palonosetron hydrochloride (NEPA) to prevent nausea and vomiting both during and after a highly emetogenic (BEAM) conditioning regimen for hematopoietic stem cell transplantation (HSCT).
SECONDARY OBJECTIVES:
- To differentiate response to NEPA over different phases of chemotherapy-induced nausea.
OUTLINE:
Within 60 minutes before standard of care BEAM treatment, patients receive netupitant and palonosetron hydrochloride orally (PO) on days 1, 3, and 6.
After completion of study treatment, patients are followed up at 14 days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (NEPA) | Experimental | Drug: Netupitant, Drug: Palonosetron Hydrochloride, Other: Questionnaire AdministrationWithin 60 minutes before standard of care BEAM treatment, patients receive netupitant and palonosetron hydrochloride PO on days 1, 3, and 6. Netupitant: 300 mg, QD, Given PO Palonosetron Hydrochloride: 0.5 mg, QD, Given PO Questionnaire Administration: Ancillary studies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must be undergoing autologous or allogeneic hematopoietic stem cell transplant (HSCT) with the BEAM conditioning regimen prior to HSCT
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 or Karnofsky Performance Score >= 60%
- Able to swallow oral medications
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (16 listed)
- Subjects with known hypersensitivity or other allergic reactions attributed to compounds of similar biologic composition to netupitant, palonosetron, dexamethasone, or other agents used in the study
- Subjects who are receiving any other investigational agents or have received another investigational drug in the last 30 days
- Subjects who have had emesis or required antiemetics in the 48 hours prior to starting the BEAM conditioning regimen; patients required to take antipsychotics, appetite stimulants, or other medications with antiemetic effects will also be excluded if those medications cannot be replaced by therapeutic equivalents
- Female subjects who are pregnant, have a positive serum human chorionic gonadotrophin (hCG), or are lactating and intend to breastfeed a child; pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with NEPA
- Human immunodeficiency virus (HIV)-positive subjects on combination antiretroviral therapy are ineligible
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 |
|---|---|---|
| NetupitantAlso: CID6451149, D05152, RO 67-3189/000300 mg, Given PO, QD | Drug | Supportive care (NEPA) |
| Palonosetron HydrochlorideAlso: Aloxi, RS 25259-1970.5 mg, Given PO, QD | Drug | Supportive care (NEPA) |
| Questionnaire AdministrationAncillary studies | Other | Supportive care (NEPA) |
Primary outcome
Complete Response (CR) Defined as no Emesis and no Rescue Therapy
Time frame: Up to 5 days post chemotherapy
Number of subjects that reached a complete response (CR), defined as having no emesis and no rescue therapy.
3 secondary outcomes
CR (Acute Phase)
Time frame: Up to 144 hours post-study drug administration on day 1
CR (Delayed Phase)
Time frame: From 145 hours up to 264 hours post-study drug administration on day 1
Complete Protection (CP) Rate Defined as CR Plus no Nausea
Time frame: Up to 264 hours post-study drug administration on day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joseph Bubalo principal investigator
OHSU Knight Cancer Institute
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 Netupitant, Palonosetron Hydrochloride and Questionnaire Administration in people with Malignant Neoplasm, run by OHSU Knight Cancer Institute 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 16 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 12 Jul 2021. 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 3 Jun 2021). 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) Defined as no Emesis and no Rescue Therapy (time frame: Up to 5 days post chemotherapy). 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 12 Jul 2021.