interventional
N/A
1 country
1
Primary Objective. Objective Response Rate (ORR) according to RECIST 1.1 criteria
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 8, 2025
Actual (reported)ORR is defined as the percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria. The determination of clinical response will be based on investigator-reported measurements. Responses will be evaluated with a chest and abdominal computed tomography (CT) scan every 8 weeks. Patients who do not have an on-study assessment will be included in the analysis as non-responders.
Progression-free survival (PFS).Overall survival (OS).Toxicity rate.Quality of Life (QoL) is
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Formulated product
VINORELBINE
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, SOFT
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
VINORELBINE
Named ingredient: Vinorelbine
View registry recordI.F.O. Istituti Fisioterapici Ospitalieri
Rome, 00144, Italy
Gianluca Bossi
First Submitted
January 8, 2025
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Source retrieved:
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