Clinical trial · Interventional
Study of Dasatinib in Patients With Advanced Solid Tumors
Phase I Study to Evaluate the Effect of Ketoconazole on the Pharmacokinetics of Dasatinib and the Effect of Dasatinib on Pharmacodynamic Markers in Patients With Advanced Solid Tumors
NCT00162214CI-TRIAL-00004681terminatedPhase 1ClinicalTrials.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)
The purpose of Segment 1 of the study is to determine the effect of ketoconazole on dasatinib. The purpose of Segment 2 is to learn how dasatinib affects tumor growth in patients with advanced solid tumors.
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 |
|---|---|---|---|
| Tumors | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dasatinib + Ketoconazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- ACTIVE_COMPARATOR
- label
- 1
- interventionNames
- Drug: Dasatinib + Ketoconazole
Primary outcomes (2)
- measure
- Segment 1: Determine whether the steady state pharmacokinetics of 20 mg of dasatinib are affected by co-administration with ketoconazole in patients with advanced solid tumors
- measure
- Segment 2: Assess the pharmacodynamic activity of dasatinib
Secondary outcomes (2)
- measure
- Segment 1: Evaluate the safety and tolerability of dasatinib alone and when co-administered with ketoconazole
- measure
- Segment 2: Explore the association between tumor response and the pre-clinically identified markers and other mRNA gene expression level
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ECOG status 0-2 * Advanced or metastatic disease, unresponsive to standard treatment (or no standard treatment exists) * Biopsy pretreatment * Adequate bone marrow, liver and kidney function Exclusion Criteria: * Serious cardiovascular disease * Bleeding disorders * Gastrointestinal (GI) tract disease * Platelet inhibitors * H2 blockers, proton pump inhibitors
References
Publications (0)
Data not yet available
No reference posted for this study.