Prevention of Breakthrough CINV in Patients Receiving Moderately or Highly Emetogenic Chemotherapy
Akynzeo or Olanzapine for Patients Who Experience Breakthrough CINV in Patient Receiving Moderately or Highly Emetogenic Chemotherapy After First Cycle of Chemotherapy
1 other identifier
interventional
100
1 country
1
Brief Summary
The purpose of the proposed study is to provide a clinical approach to chemotherapy induced nausea and vomiting (CINV) prophylaxis in cycle 2 of moderately emetogenic chemotherapy or highly emetogenic chemotherapy for patients who developed breakthrough CINV after cycle 1 based on the available data in the literature as well as the recommendations provided by established guidelines
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2023
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 9, 2023
CompletedFirst Submitted
Initial submission to the registry
September 24, 2023
CompletedFirst Posted
Study publicly available on registry
October 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedOctober 10, 2023
September 1, 2023
4 months
September 24, 2023
October 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
COMPELETE RESPONSE, no vomiting or use of rescue medications
No vomiting or use of rescue medications for 5 days post chemotherapy
5 DAYS post chemotherapy
Study Arms (2)
AKYNZEO for patient receiving MEC
ACTIVE COMPARATORAdd Akynzeo to 5HT3 And dexamethasone
oLANZAPINE and Akynzeo to patients receiving highly emetogenic
ACTIVE COMPARATORolANZAPINE plus Akynzeo
Interventions
OLANZAPINE
Eligibility Criteria
You may qualify if:
- CHEMOTHERAPY NAIIVE
- patient receiving moderately or highly emetogenic chemotherapy
- lung cancer
- breast cancer
You may not qualify if:
- PRIOR CHEMOTHERAPY for any cancer
- nausea or vomiting 24 hours prior to study entry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Simon Williamson Cliniclead
- Helsinn Healthcare SAcollaborator
Study Sites (1)
Rudolph M Navari
Mount Olive, Alabama, 35117, United States
Related Publications (1)
Navari RM, Bonizzoni E. NEPA (Netupitant/Palonosetron) for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Patients Receiving Highly or Moderately Emetogenic Chemotherapy Who Experienced Breakthrough CINV in Cycle 1 of Chemotherapy: A Phase II Clinical Trial. Cancer Med. 2025 Apr;14(7):e70549. doi: 10.1002/cam4.70549.
PMID: 40145359DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double Blind
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2023
First Posted
October 4, 2023
Study Start
September 9, 2023
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
October 10, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share