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clinical research study to find out if buparlisib (BKM120) in combination with docetaxel therapy is safe and has beneficial effects in people who have advanced or metastatic squamous non-small cell lu...

Mise à jour : Il y a 4 ans
Référence : EUCTR2013-000833-11

clinical research study to find out if buparlisib (BKM120) in combination with docetaxel therapy is safe and has beneficial effects in people who have advanced or metastatic squamous non-small cell lung cancer and were previously treated with platinum-based chemotherapy

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Extrait

For phase Ib: To determine the maximum-tolerated dose (MTD) / recommended Phase II dose (RP2D) of buparlisib when administered orally in combination with every-3-week administration of docetaxel to adult patients with Stage IIIb or Stage IV NSCLC of squamous histology previously treated with platinum-based chemotherapy For phase II: To estimate the treatment effect of every-three-week administration of docetaxel and daily buparlisib or placebo on PFS in patients previously treated with platinum-based chemotherapy for advanced or metastatic squamous NSCLC

Critère d'inclusion

  • advanced/metastatic squamous non small cell lung cancer

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