Clinical trial • Phase II • Oncology
NAZARTINIB for Advanced cancer
Phase II trial of NAZARTINIB for Advanced cancer. open-label. 3 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced cancer
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 11-04-2024
- First CTIS Authorization Date
- 17-04-2024
Trial design
open-label Phase II trial across 2 sites in Spain, Germany.
- Open Label
- Yes
- Target Sample Size
- 3
Eligibility
Recruits 3 isVulnerablePopulationSelected is true. Subject information and consent documents available in the submission include: 'L1_ICF - Main ICF - Adult_1_DE_German_Red', 'L1_ICF - Follow up for pregnant partner of participant_1_DE_German_NonRed', and 'L2_ICF Procedure_1_DE_English_NonRed' (document titles indicate German and English ICFs). No explicit assent/parental consent procedures for minors are provided in the available records..
- Vulnerable Population
- isVulnerablePopulationSelected is true. Subject information and consent documents available in the submission include: 'L1_ICF - Main ICF - Adult_1_DE_German_Red', 'L1_ICF - Follow up for pregnant partner of participant_1_DE_German_NonRed', and 'L2_ICF Procedure_1_DE_English_NonRed' (document titles indicate German and English ICFs). No explicit assent/parental consent procedures for minors are provided in the available records.
Inclusion criteria
- {"criterion_text":"- Patient is currently enrolled in an eligible Novartis-sponsored ribociclib (LEE011) study and is receiving ribociclib as single agent or in combination with other investigational treatments.\n- Patient is currently deriving clinical benefit from the study treatment, as determined by the investigator.\n- Patient has demonstrated compliance, as assessed by the investigator, with the parent protocol requirements."}
Exclusion criteria
- {"criterion_text":"- Patients who have permanently discontinued from ribociclib (LEE011) in the parent protocol for any reason\n- Patients who do not meet parent protocol criteria to continue study treatment."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Number of patients receiving ribociclib as single agent or in combination with other investigational treatments under the rollover study, duration of exposure","definition_or_measurement_approach":"Number of patients receiving ribociclib (count) and duration of exposure (treatment exposure time) as reported under the rollover study."}
Secondary endpoints
- {"endpoint_text":"- Frequency and nature of adverse events (AEs), serious adverse events (SAE) and liver function tests","definition_or_measurement_approach":"Assessment of frequency and nature (type, severity) of AEs and SAEs and monitoring results of liver function tests."}
Recruitment
- Planned Sample Size
- 3
- Recruitment Window Months
- 113
- Consent Approach
- Informed consent is documented via subject information and informed consent form documents included in the submission (e.g. 'L1_ICF - Main ICF - Adult' and related ICFs). Document titles indicate availability in German and English. No further details on assent for minors or additional consent procedures are provided in the available records.
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 2
Spain
- Earliest CTIS Part Ii Submission Date
- 05-04-2024
- Latest Decision Or Authorization Date
- 17-04-2024
- Processing Time Days
- 12
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- 1301: Oncología
- Principal Investigator Name
- Daniel Castellano Gauna
- Principal Investigator Email
- cdanicas@hotmail.com
- Contact Person Name
- Daniel Castellano Gauna
- Contact Person Email
- cdanicas@hotmail.com
- Number Of Participants
- 1
Germany
- Earliest CTIS Part Ii Submission Date
- 04-08-2025
- Latest Decision Or Authorization Date
- 27-08-2025
- Processing Time Days
- 23
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- University Hospital Cologne AöR
- Department Name
- #1200: Klinik I fuer Innere Medizin
- Principal Investigator Name
- Juergen Wolf
- Principal Investigator Email
- Juergen.wolf@uk-koeln.de
- Contact Person Name
- Juergen Wolf
- Contact Person Email
- Juergen.wolf@uk-koeln.de
- Number Of Participants
- 1
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- Sponsor duties codes: [{"id":877466,"code":"10"}]; contact: eu_clinical_trials_information@iqvia.com
- Name
- Icon Clinical Research Limited
- Responsibilities
- Sponsor duties codes: [{"id":877464,"code":"1"}]; contact: Triona.PriceSmith1@docsglobal.com
- Name
- Parexel International (IRL) Limited
- Responsibilities
- Sponsor duties codes: [{"id":877465,"code":"12"}]; contact: Clinicaltrial.Enquiries@parexel.com
- Name
- Syneos Health Inc.
- Responsibilities
- Sponsor duties codes: [{"id":877463,"code":"1"}]; contact: sm_ctis@syneoshealth.com
Third parties
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"[{\"id\":877466,\"code\":\"10\"}], contact email: eu_clinical_trials_information@iqvia.com","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"[{\"id\":877464,\"code\":\"1\"}], contact email: Triona.PriceSmith1@docsglobal.com","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"[{\"id\":877465,\"code\":\"12\"}], contact email: Clinicaltrial.Enquiries@parexel.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"[{\"id\":877463,\"code\":\"1\"}], contact email: sm_ctis@syneoshealth.com","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- EGF816
- Active Substance
- NAZARTINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- prodAuthStatus:1
- Investigational Product Name
- LEE011
- Active Substance
- RIBOCICLIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- prodAuthStatus:1
- Combination Treatment
- Yes
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