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Clinical trial

Akynzeo or Olanzapine for Patients Who Experience Breakthrough CINV in Patient Receiving Moderately or Highly Emetogenic Chemotherapy After First Cycle of Chemotherapy

ID
Name
SWC999
Description
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 arms
Trial start
2023-09-09
Estimated PCD
2023-12-31
Trial end
2023-12-31
Status
Recruiting
Phase
Early phase I
Treatment
Akynzeo
OLANZAPINE
Arms:
AKYNZEO for patient receiving MEC, oLANZAPINE and Akynzeo to patients receiving highly emetogenic
Other names:
Olanzapine
Size
100
Primary endpoint
COMPELETE RESPONSE, no vomiting or use of rescue medications
5 DAYS post chemotherapy
Eligibility criteria
Inclusion Criteria: * CHEMOTHERAPY NAIIVE * patient receiving moderately or highly emetogenic chemotherapy * lung cancer * breast cancer Exclusion Criteria: * PRIOR CHEMOTHERAPY for any cancer * nausea or vomiting 24 hours prior to study entry
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Double Blind', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-10-10

1 organization

1 product

1 indication

Organization
Simon Williamson Clinic
Product
Akynzeo
Indication
Chemotherapy-Induced Nausea and Vomiting