Combination of Netupitant and Palonosetron (Akynzeo®) in the Treatment of Refractory CINV (CINV)
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|ClinicalTrials.gov Identifier: NCT03008213|
Recruitment Status : Not yet recruiting
First Posted : January 2, 2017
Last Update Posted : January 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chemotherapy Induced Nausea Vomiting||Drug: Netupitant and Palonosetron||Phase 2|
This is a Phase II, single-center, single-arm, open-label, feasibility trial using a fixed dose combination of netupitant and palonosetron (Akynzeo®) in the treatment of refractory CINV. The primary aim of this study is feasibility, defined as 70% completion rate of all study procedures over 7 days.
Eligible subjects will be identified in weekly palliative care patient triage meetings. Patients who are 18 years of age or older, have histologically confirmed cancer, and confirmed refractory CINV will be eligible. After obtaining written informed consent and verifying that the study subject meets all eligibility criteria, the subject will be enrolled in the study through the University California San Diego (UCSD) Moores Cancer Center Clinical Trials Office. Subjects will be allowed to participate only once in the study. Study Day 1 will be the day of Akynzeo® dosing. Subjects will receive a single capsule of Akynzeo® (300 mg of netupitant and 0.5 mg of palonosetron) on Study 1. Study drug may be taken with or without food. Subjects will complete a study drug diary to document date and time of Akynzeo® administration. On Study Day 1, the study coordinator will educate the subject on how to complete the Multinational Association of Supportive Care in Cancer (MASCC) Antiemesis Tool, and Functional Living Index Emesis (FLIE) scale, and medication diary and each of these documents will be completed for that day. An adequate number of copies of each subject questionnaire and diary will be provided to the subject on Study Day 1 for completion at home during the post-treatment observation portion of the study (Study Days 2-7) as needed.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Fixed Dose Combination of Netupitant and Palonosetron (Akynzeo®) in the Treatment of Refractory Chemotherapy-Induced Nausea and Vomiting|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||June 2020|
Experimental: Netupitant and Palonosetron
Subjects will be allowed to participate only once in the study. Study Day 1 will be the day of Akynzeo® dosing. Subjects will receive a single capsule of Akynzeo® (300 mg of netupitant and 0.5 mg of palonosetron) on Study 1.
Drug: Netupitant and Palonosetron
300 mg of netupitant and 0.5 mg of palonosetron
Other Name: Akynzeo
- Number of participants completed all study procedures over seven days [ Time Frame: Through study completion, 7 days ]
The proposed study is a prospective, single-center, feasibility trial. The primary aim of this study is feasibility - specifically feasibility will be defined as completion of all study procedures over seven days.
For the primary aim, we assume an acceptable completion rate from strata of MEC/HEC or tumor types of all study-related procedures would be at least 70%. Assuming a true completion rate of 85%, a sample size of 50 patients would have an 80% power to detect an absolute difference of 15% at Type I error 0.05.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03008213
|Contact: Eric Roeland, MD||858-534-7079|
|Principal Investigator:||Eric Reland, MD||UCSD|