- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03097588
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 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)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. 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:
I. 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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- OHSU Knight Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Supportive care (NEPA)
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 |
Ancillary studies
300 mg, Given PO, QD
Other Names:
0.5 mg, Given PO, QD
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 5 days post chemotherapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CR (Acute Phase)
Time Frame: Up to 144 hours post-study drug administration on day 1
|
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.
|
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
|
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.
|
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
|
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.
|
Up to 264 hours post-study drug administration on day 1
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Emetic Episodes and Received Rescue Agents
Time Frame: Up to 264 hours
|
The number of participants that had emetic episodes and received rescue agents (medications).
|
Up to 264 hours
|
Number of Participants With Emetic Episodes and Received Rescue Agents (Acute Phase)
Time Frame: Up to 144 hours post-study drug administration on day 1
|
The number of participants that had emetic episodes and received rescue agents (medications) (acute phase: for 0 to 144 hours timeframe of study drug administration)
|
Up to 144 hours post-study drug administration on day 1
|
Number of Participants With Emetic Episodes and Received Rescue Agents (Acute Phase)
Time Frame: Up to 24 hours post-study drug administration on day 1
|
The number of participants that had emetic episodes and received rescue agents (medications) (for 0 to 24 hours timeframe of study drug administration)
|
Up to 24 hours post-study drug administration on day 1
|
Number of Participants With Emetic Episodes and Received Rescue Agents (Delayed Phase)
Time Frame: From 145 hours up to 264 hours post-study drug administration on day 1
|
The number of participants that had emetic episodes and received rescue agents (medications) during the delayed phase (for 145 hours up to 264 hours timeframe)
|
From 145 hours up to 264 hours post-study drug administration on day 1
|
Mean Levels of Nausea Per Day Assessed by Chemotherapy Induced Nausea and Vomiting Questionnaire
Time Frame: Up to 11 days
|
The mean level of nausea per day assessed by chemotherapy induced nausea and vomiting questionnaire.
The full range of nausea level score on the questionnaire was from minimum value of 0 to a maximum value of 10. 0= no nausea or vomiting, and 10= worst nausea and vomiting.
Higher score means a worse outcome.
|
Up to 11 days
|
Time to First Emesis and Time to Receiving First Rescue Medication
Time Frame: Up to 264 hours
|
Will be depicted via Kaplan-Meier curves showing the percentage of patients who had no emesis or rescue medication use for the acute and delayed time periods.
|
Up to 264 hours
|
Time to Receiving First Rescue Medication and First Emesis
Time Frame: Up to 264 hours
|
Will be depicted via Kaplan-Meier curves showing the percentage of patients who had no emesis or rescue medication use for the acute and delayed time periods.
|
Up to 264 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joseph Bubalo, OHSU Knight Cancer Institute
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Signs and Symptoms, Digestive
- Neoplasms
- Vomiting
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Serotonin Agents
- Serotonin Antagonists
- Serotonin 5-HT3 Receptor Antagonists
- Palonosetron
Other Study ID Numbers
- STUDY00016288 (OTHER: OHSU Knight Cancer Institute)
- NCI-2017-00548 (REGISTRY: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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