Conditions: Neoplasms
Keywords: Solid tumors
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 151
Healthy volunteers: no

Brief summary:
To evaluate the safety and tolerability of oral SKI-606 (bosutinib) administered on a daily schedule to subjects with advanced malignant solid tumors and to define a maximum tolerated dose (MTD) in this subject population.

Detailed description:

Arms:
arm 1: Dose finding study of monotherapy bosutinib in patients with advanced solid tumors. arm 2: Enroll 30 patients at RP2D to further evaluate safety and efficacy in subgroup population. arm 3: Enroll 30 patients at RP2D to further evaluate safety and efficacy in subgroup population. arm 4: Enroll 30 patients at RP2D to further evaluate safety and efficacy in subgroup population.

Interventions: intervention 1: bosutinib intervention 2: bosutinib intervention 3: bosutinib intervention 4: bosutinib
Intervention descriptions: intervention 1: Dose levels evaluated 50mg, 100mg, 200mg, 300mg, 400mg, 500mg and 600mg. 500mg was identified as MTD, however due to GI toxicities at that dose, 400mg was selected as the RP2D. Drug was administered as long as tolerable and disease under study did not worsen. intervention 2: 400mg QD bosutinib, as long as tolerated and disease under study does not worsen. intervention 3: 400mg QD bosutinib, as long as tolerated and disease under study does not worsen. intervention 4: 400mg QD bosutinib, as long as tolerated and disease under study does not worsen.

Protocol document: