Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
Primary Objective:
Secondary objectives are:
Full description
The duration of the study for a patient will include a period for inclusion of up to 3 weeks. The patients may continue treatment up to a maximum of 6 cycles or until disease progression, unacceptable toxicity or consent withdrawal, followed by a minimum of 30-day follow-up after the last study treatment administration.
Patients will be followed for at least 30 days after the last administration of study treatment for safety purpose. In case of study treatment discontinuation without disease progression, efficacy data will be collected every 6 weeks until disease progression, death or end of study whatever comes first. After disease progression, the patient will be followed-up every 12 weeks (3 months) for overall survival (OS) until death or end of study whatever comes first.
The end of the study will be one year after the first dose of the last treated patient.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Primary purpose
Allocation
Interventional model
Masking
119 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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