At a glance
ClinicalIndex Comparison Record- ✓Advanced or recurrent solid malignancy confirmed histologically or cytologically with no effective therapy available
- ✓ECOG performance status 0-1
- ✓Measurable disease per modified RECIST criteria
- ✕Systemic antitumor agents or investigational agents within 28 days before first dose
- ✕Prior exposure to SKI-606 or any other Src-kinase inhibitor
- ✕Major surgery or radiotherapy within 14 days before first dose (must be completely recovered by Day 1)
- ✕Active CNS metastases with clinical symptoms, cerebral edema, corticosteroid requirement, or progressive growth
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I Dose-Escalation Study Of Oral SKI-606 In Subjects With Advanced Malignant Solid Tumors
In Brief
A Phase 1 clinical trial evaluating bosutinib for Neoplasms. Completed, enrolled 151 participants across 19 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.
400mg QD bosutinib, as long as tolerated and disease under study does not worsen.
400mg QD bosutinib, as long as tolerated and disease under study does not worsen.
400mg QD bosutinib, as long as tolerated and disease under study does not worsen.