Clinical trial · Interventional
Tumor Kinase Inhibitor Concentrations Measured by PET
Measurement of Tumor Kinase Inhibitor Concentrations Using PET Imaging in Patients With Advanced Solid Malignancies
- 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 investigators hypothesize that response to kinase inhibitors is dependent on achieving pharmacological active drug levels in tumor tissue and that quantitative PET imaging can predict kinase inhibitors tumor concentrations. The ultimate aim is to develop a quantitative PET based imaging tool to differentiate between patients who will respond to therapy with kinase inhibitors. The main objective of this study is to determine whether tumor concentrations of kinase inhibitors at pharmacological active doses can be predicted from PET studies using tracer amounts (microdosing) of corresponding radiolabeled kinase inhibitors. This objective includes the development and validation of pharmacokinetic models for radiolabeled kinase inhibitors as well as validation of the microdosing concept for kinase inhibitors.
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 |
|---|---|---|---|
| Disseminated Malignant Neoplasm | Disseminated Malignant Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [11C] kinase inhibitor PET [15O]water PET and tumor biopsies. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- one
- interventionNames
- Other: [11C] kinase inhibitor PET [15O]water PET and tumor biopsies.
Primary outcomes (2)
- measure
- tumor concentrations of a microdose radiolabeled kinase inhibitor
- timeFrame
- before start of treatment and after two weeks of treatment with a kinase inhibitor
- description
- a radiolabeled kinase inhibitor PET is used to asses this outcome measure
- measure
- tumor concentrations of therapeutic kinase inhibitor
- timeFrame
- after 2 weeks of treatment with a kinase inhibitor
- description
- measured in a tumor biopsy with LC-MS/MS
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must have a histologically confirmed diagnosis of an advanced or metastatic solid malignancy. 2. Patients must have confirmed radiological or clinical progressive disease. 3. Patients must have at least one measurable tumor lesion outside the liver. 4. Indication for standard use of sorafenib or erlotinib 5. Age ≥ 18 years. 6. ECOG Performance Status ≤ 2. 7. Life expectancy of at least 12 weeks. 8. Patients should be able to swallow oral medication. 9. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: 1. Hemoglobin \> 6.0 mmol/L 2. Absolute neutrophil count (ANC) \>1,5 x 10\*9/L 3. Platelet count ≥ 100 x 10\*9/L 4. Total bilirubin \< 2 times the upper limit of normal (ULN) 5. ALT and AST \< 2.5 x ULN; \< 5x ULN in case of liver metastases, except for patients with hepatocellular carcinoma, than Child Pugh classification A-B. 6. Alkaline phosphatase \< 4 x ULN; \< 5x ULN in case of liver metastases, except for patients with hepatocellular carcinoma, than Child Pugh classification A-B. 7. Serum creatinine eGFR ≥ 50 mL/min. 8. PT-INR/PTT \< 1.5 x ULN, unless coumarin derivatives are used. 9. Activated partial thromboplastin time \< 1.25 x ULN (therapeutic anticoagulation therapy is allowed, if this treatment can be interrupted for a biopsy as judged by the treating physician). Exclusion Criteria: 1. Concurrent treatment with other anticancer agents or experimental drugs. 2. History of cardiac disease: 1. Congestive heart failure \>NYHA class 2. 2. Active Coronary Artery Disease (defined as myocardial infarction within 6 months prior to screening). 3. Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted). 3. Uncontrolled hypertension. Blood pressure must be ≤160/95 mmHg at the time of screening on a stable antihypertensive regimen. Blood pressure must be stable on at least 2 separate measurements. 4. Uncontrolled infections (\> grade 2 NCI-CTC version 4.0). 5. Subjects with serious non-healing wound, ulcer, or bone fracture. 6. Patients with thromboembolic events within 3 months prior to study inclusion. 7. Significant skin condition interfering with treatment 8. Patients undergoing renal dialysis. 9. Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must agree to use adequate barrier birth control measures (e.g., cervical cap, condom, or diaphragm) during the course of the trial. Oral birth control methods alone will not be considered adequate on this study, because of the potential pharmacokinetic interaction between study drug and oral contraceptives. Concomitant use of oral and barrier contraceptives is advised. Contraception is necessary for at least 6 months after receiving the study kinase inhibitor. 10. Concomitant use of dexamethasone, anti-convulsants and anti-arrhythmic drugs other than digoxin or beta blockers. 11. Major surgery within 28 days prior to start of treatment. 12. Medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results. 13. Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.
References
Publications (1)
- BACKGROUNDBahce I, Smit EF, Lubberink M, van der Veldt AA, Yaqub M, Windhorst AD, Schuit RC, Thunnissen E, Heideman DA, Postmus PE, Lammertsma AA, Hendrikse NH. Development of [(11)C]erlotinib positron emission tomography for in vivo evaluation of EGF receptor mutational status. Clin Cancer Res. 2013 Jan 1;19(1):183-93. doi: 10.1158/1078-0432.CCR-12-0289. Epub 2012 Nov 7. PMID 23136193