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

NCT03097588 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: STUDY00016288NCI-2017-00548
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 5 days post chemotherapy

Secondary Outcomes (3)

• CR (Acute Phase)

  Up to 144 hours post-study drug administration on day 1

• CR (Delayed Phase)

  From 145 hours up to 264 hours post-study drug administration on day 1

• Complete Protection (CP) Rate Defined as CR Plus no Nausea

  Up to 264 hours post-study drug administration on day 1

Other Outcomes (7)

• Number of Participants With Emetic Episodes and Received Rescue Agents

  Up to 264 hours

• Number of Participants With Emetic Episodes and Received Rescue Agents (Acute Phase)

  Up to 144 hours post-study drug administration on day 1

• Number of Participants With Emetic Episodes and Received Rescue Agents (Acute Phase)

  Up to 24 hours post-study drug administration on day 1

Study Arms (1)

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

Drug: Netupitant; Drug: Palonosetron Hydrochloride; Other: Questionnaire Administration

Interventions

Netupitant DRUG

300 mg, Given PO, QD

Also known as: CID6451149, D05152, RO 67-3189/000

Supportive care (NEPA)

Palonosetron Hydrochloride DRUG

0.5 mg, Given PO, QD

Also known as: Aloxi, RS 25259-197

Supportive care (NEPA)

Questionnaire Administration OTHER

Ancillary studies

Supportive care (NEPA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Helsinn Therapeutics (U.S.), Inc: collaborator
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

netupitant; Palonosetron

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Joseph Bubalo, PharmD (Oncology Clinical Pharmacy Specialist)
• Organization: Department of Pharmacy Services, Oregon health & Science University Hospital

bubaloj@ohsu.edu

5034948007

Study Officials

• Joseph Bubalo

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: March 31, 2017
• Study Start: April 27, 2017
• Primary Completion: February 20, 2020
• Study Completion: March 20, 2020
• Last Updated: July 12, 2021
• Results First Posted: June 3, 2021

Record last verified: 2021-06

Locations

US (1)