Trial Outcomes & Findings for Netupitant and Palonosetron Hydrochloride in Preventing Chemotherapy Induced Nausea and Vomiting in Patients With Cancer Undergoing BEAM Conditioning Regimen Before Stem Cell Transplant (NCT NCT03097588)

NCT ID: NCT03097588

Last Updated: 2021-07-12

Results Overview

Number of subjects that reached a complete response (CR), defined as having no emesis and no rescue therapy.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 43 participants
• Primary outcome timeframe: Up to 5 days post chemotherapy
• Results posted on: 2021-07-12

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	43
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	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
Overall Study Adverse Event	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Supportive Care (NEPA) n=43 Participants 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
Age, Continuous	55 years n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	41 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native Hawaiian/other Pacific Highlander	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 days post chemotherapy

Number of subjects that reached a complete response (CR), defined as having no emesis and no rescue therapy.

Outcome measures

Measure	Supportive Care (NEPA) n=42 Participants 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
Complete Response (CR) Defined as no Emesis and no Rescue Therapy	13 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Supportive Care (NEPA) n=42 Participants 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
CR (Acute Phase)	12 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Supportive Care (NEPA) n=42 Participants 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
CR (Delayed Phase)	1 Participants

SECONDARY outcome

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

Population: 42 participants completed the study and therefore were analyzed for response.

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.

Outcome measures

Measure	Supportive Care (NEPA) n=42 Participants 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
Complete Protection (CP) Rate Defined as CR Plus no Nausea	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 264 hours

The number of participants that had emetic episodes and received rescue agents (medications).

Outcome measures

Measure	Supportive Care (NEPA) n=43 Participants 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
Number of Participants With Emetic Episodes and Received Rescue Agents Number of participants who had emetic episodes	8 Participants
Number of Participants With Emetic Episodes and Received Rescue Agents Number of participants who were given rescue meds	36 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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)

Outcome measures

Measure	Supportive Care (NEPA) n=43 Participants 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
Number of Participants With Emetic Episodes and Received Rescue Agents (Acute Phase) Number of participants who had an emetic episode in acute phase	0 Participants
Number of Participants With Emetic Episodes and Received Rescue Agents (Acute Phase) Number of participants who were given rescue meds in acute phase	13 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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)

Outcome measures

Measure	Supportive Care (NEPA) n=43 Participants 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
Number of Participants With Emetic Episodes and Received Rescue Agents (Acute Phase) Number of participants that had emetic episodes	0 Participants
Number of Participants With Emetic Episodes and Received Rescue Agents (Acute Phase) Number of participants that were given rescue meds-	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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)

Outcome measures

Measure	Supportive Care (NEPA) n=43 Participants 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
Number of Participants With Emetic Episodes and Received Rescue Agents (Delayed Phase) The number of participants that had an emetic episode	8 Participants
Number of Participants With Emetic Episodes and Received Rescue Agents (Delayed Phase) The number of participants that were given rescue meds	23 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Supportive Care (NEPA) n=43 Participants 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
Mean Levels of Nausea Per Day Assessed by Chemotherapy Induced Nausea and Vomiting Questionnaire	2.79 score on a scale Interval 0.0 to 10.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Supportive Care (NEPA) n=43 Participants 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
Time to First Emesis and Time to Receiving First Rescue Medication Median time to receiving rescue medication	148.4 Hours Interval 130.2 to 185.1
Time to First Emesis and Time to Receiving First Rescue Medication Time to first emesis	216 Hours Interval 168.0 to 240.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Supportive Care (NEPA) n=43 Participants 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
Time to Receiving First Rescue Medication and First Emesis Mean time to first rescue medication	143 Hours Standard Deviation 55.27
Time to Receiving First Rescue Medication and First Emesis Mean time to first emesis	8.9 Hours Standard Deviation 0.83

Adverse Events

Supportive Care (NEPA)

Serious events: 1 serious events

Other events: 43 other events

Deaths: 1 deaths

Serious adverse events

Measure	Supportive Care (NEPA) n=43 participants at risk 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
Gastrointestinal disorders Vomiting	2.3% 1/43 • Number of events 1 • Adverse event collection will begin when subject takes their first dose of study drug and continues until the subject completes the End of Study visit, up to 20 days, or until 1 month if toxicity on trial occurs, whichever comes later. Maximum duration up to 1 month.
Respiratory, thoracic and mediastinal disorders Aspiration	2.3% 1/43 • Number of events 1 • Adverse event collection will begin when subject takes their first dose of study drug and continues until the subject completes the End of Study visit, up to 20 days, or until 1 month if toxicity on trial occurs, whichever comes later. Maximum duration up to 1 month.
Investigations Transfusion Related Acute Lung Injury	2.3% 1/43 • Number of events 1 • Adverse event collection will begin when subject takes their first dose of study drug and continues until the subject completes the End of Study visit, up to 20 days, or until 1 month if toxicity on trial occurs, whichever comes later. Maximum duration up to 1 month.
Cardiac disorders Pulseless Electrical Activity	2.3% 1/43 • Number of events 1 • Adverse event collection will begin when subject takes their first dose of study drug and continues until the subject completes the End of Study visit, up to 20 days, or until 1 month if toxicity on trial occurs, whichever comes later. Maximum duration up to 1 month.

Other adverse events

Measure	Supportive Care (NEPA) n=43 participants at risk 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
Gastrointestinal disorders Abdominal cramping	14.0% 6/43 • Number of events 6 • Adverse event collection will begin when subject takes their first dose of study drug and continues until the subject completes the End of Study visit, up to 20 days, or until 1 month if toxicity on trial occurs, whichever comes later. Maximum duration up to 1 month.
Gastrointestinal disorders Colitis	41.9% 18/43 • Number of events 18 • Adverse event collection will begin when subject takes their first dose of study drug and continues until the subject completes the End of Study visit, up to 20 days, or until 1 month if toxicity on trial occurs, whichever comes later. Maximum duration up to 1 month.
Blood and lymphatic system disorders Anemia	81.4% 35/43 • Number of events 35 • Adverse event collection will begin when subject takes their first dose of study drug and continues until the subject completes the End of Study visit, up to 20 days, or until 1 month if toxicity on trial occurs, whichever comes later. Maximum duration up to 1 month.
Blood and lymphatic system disorders CD4 Lymphocytes decreased	14.0% 6/43 • Number of events 6 • Adverse event collection will begin when subject takes their first dose of study drug and continues until the subject completes the End of Study visit, up to 20 days, or until 1 month if toxicity on trial occurs, whichever comes later. Maximum duration up to 1 month.
Blood and lymphatic system disorders Febrile Neutropenia	27.9% 12/43 • Number of events 12 • Adverse event collection will begin when subject takes their first dose of study drug and continues until the subject completes the End of Study visit, up to 20 days, or until 1 month if toxicity on trial occurs, whichever comes later. Maximum duration up to 1 month.
Blood and lymphatic system disorders Lymphocyte count reduced	74.4% 32/43 • Number of events 32 • Adverse event collection will begin when subject takes their first dose of study drug and continues until the subject completes the End of Study visit, up to 20 days, or until 1 month if toxicity on trial occurs, whichever comes later. Maximum duration up to 1 month.
Blood and lymphatic system disorders Neutropenia	76.7% 33/43 • Number of events 33 • Adverse event collection will begin when subject takes their first dose of study drug and continues until the subject completes the End of Study visit, up to 20 days, or until 1 month if toxicity on trial occurs, whichever comes later. Maximum duration up to 1 month.
Blood and lymphatic system disorders Leukopenia	95.3% 41/43 • Number of events 41 • Adverse event collection will begin when subject takes their first dose of study drug and continues until the subject completes the End of Study visit, up to 20 days, or until 1 month if toxicity on trial occurs, whichever comes later. Maximum duration up to 1 month.
Cardiac disorders Hypertension	7.0% 3/43 • Number of events 3 • Adverse event collection will begin when subject takes their first dose of study drug and continues until the subject completes the End of Study visit, up to 20 days, or until 1 month if toxicity on trial occurs, whichever comes later. Maximum duration up to 1 month.
General disorders Fatigue	9.3% 4/43 • Number of events 4 • Adverse event collection will begin when subject takes their first dose of study drug and continues until the subject completes the End of Study visit, up to 20 days, or until 1 month if toxicity on trial occurs, whichever comes later. Maximum duration up to 1 month.
Infections and infestations Bacteremia	11.6% 5/43 • Number of events 5 • Adverse event collection will begin when subject takes their first dose of study drug and continues until the subject completes the End of Study visit, up to 20 days, or until 1 month if toxicity on trial occurs, whichever comes later. Maximum duration up to 1 month.
Metabolism and nutrition disorders Hyperglycemia	7.0% 3/43 • Number of events 3 • Adverse event collection will begin when subject takes their first dose of study drug and continues until the subject completes the End of Study visit, up to 20 days, or until 1 month if toxicity on trial occurs, whichever comes later. Maximum duration up to 1 month.
Metabolism and nutrition disorders Hypoalbuminemia	14.0% 6/43 • Number of events 6 • Adverse event collection will begin when subject takes their first dose of study drug and continues until the subject completes the End of Study visit, up to 20 days, or until 1 month if toxicity on trial occurs, whichever comes later. Maximum duration up to 1 month.
Metabolism and nutrition disorders Hypokalemia	14.0% 6/43 • Number of events 6 • Adverse event collection will begin when subject takes their first dose of study drug and continues until the subject completes the End of Study visit, up to 20 days, or until 1 month if toxicity on trial occurs, whichever comes later. Maximum duration up to 1 month.
Metabolism and nutrition disorders Hypophosphatemia	14.0% 6/43 • Number of events 6 • Adverse event collection will begin when subject takes their first dose of study drug and continues until the subject completes the End of Study visit, up to 20 days, or until 1 month if toxicity on trial occurs, whichever comes later. Maximum duration up to 1 month.
Blood and lymphatic system disorders Thrombocytopenia	90.7% 39/43 • Number of events 39 • Adverse event collection will begin when subject takes their first dose of study drug and continues until the subject completes the End of Study visit, up to 20 days, or until 1 month if toxicity on trial occurs, whichever comes later. Maximum duration up to 1 month.

Additional Information

Joseph Bubalo, PharmD (Oncology Clinical Pharmacy Specialist)

Department of Pharmacy Services, Oregon health & Science University Hospital

Phone: 5034948007

Email: bubaloj@ohsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place