Clinical trial · Interventional
Study Evaluating SKI-606 (Bosutinib) In Advanced Malignant Solid Tumors
Phase I Dose-Escalation Study Of Oral SKI-606 In Subjects With Advanced Malignant Solid Tumors
NCT00195260CI-TRIAL-00009390completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bosutinib | Drug | Bosutinib | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Dose escalation
- description
- Dose finding study of monotherapy bosutinib in patients with advanced solid tumors.
- interventionNames
- Drug: bosutinib
- type
- EXPERIMENTAL
- label
- Colorectal Cancer
- description
- Enroll 30 patients at RP2D to further evaluate safety and efficacy in subgroup population.
- interventionNames
- Drug: bosutinib
- type
- EXPERIMENTAL
- label
- Pancreatic Cancer
- description
- Enroll 30 patients at RP2D to further evaluate safety and efficacy in subgroup population.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced or recurrent solid malignancy confirmed histologically or cytologically for which no effective therapy is available. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1. * Measurable disease as outlined by the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. * Other inclusion applies. Exclusion Criteria: * Use of any systemic antitumor agents or any investigational agent within 28 days before the first dose of test article is administered. * Prior exposure to SKI-606 or any other Src-kinase inhibitor, major surgery or radiotherapy within 14 days before the first dose of test article (recovery from previous surgery should be complete before day 1). * Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, requirement for corticosteroids and/or progressive growth (Treated CNS metastases must be stable for \>= 2 weeks before day 1). * Other exclusion applies.
References
Publications (1)
- DERIVEDHsyu PH, Mould DR, Abbas R, Amantea M. Population pharmacokinetic and pharmacodynamic analysis of bosutinib. Drug Metab Pharmacokinet. 2014;29(6):441-8. doi: 10.2133/dmpk.DMPK-13-RG-126. Epub 2014 Jun 10. PMID 24919837