To establish the anti-tumour effect of this metronomic combination regimen defined by progression-free survival (PFS) after two cycles of treatment (4 months) and 12 months of treatment, as well as response rate after any number of cycles of treatment ("best response"). To define the safety profile of the combination. To characterize pharmacodynamics of the drug combination with the use of angiogenic markers (CEP, CEC, microparticles).
Multi-center, combination phase II study, open-label, non-comparative, non-randomized. All progressive or recurrent solid tumours will be included in the Phase II study, provided there are no curative options anymore. Total expected number of patients (minimum maximum): 54 to 90 (2-stage design)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
79
Assistance Publique Hopitaux de Marseille
Marseille, France
Anti-tumour efficacy
Time frame: 3 YEARS
Safety AND Pharmacodynamic Study
Time frame: 3 YEARS
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