Overview

Netupitant and Palonosetron Hydrochloride in Preventing Chemotherapy Induced Nausea and Vomiting in Patients With Cancer Undergoing BEAM Conditioning Regimen Before Stem Cell Transplant

Status:
Completed
Trial end date:
2020-03-20
Target enrollment:
0
Participant gender:
All
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. 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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
OHSU Knight Cancer Institute
Collaborators:
Helsinn Therapeutics (U.S.), Inc
National Cancer Institute (NCI)
Oregon Health and Science University
Treatments:
Palonosetron
Criteria
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