Clinical trial · Interventional
Absorption, Distribution, Metabolism and Excretion (ADME) Study of TKI258 in Patients With Advanced Solid Malignancies
An Open-Label, Non-Randomized, Single-Center, Phase I Study to Determine the Absorption, Distribution, Metabolism and Excretion (ADME) of TKI258 After a Single Oral Administration of TKI258 500mg and to Assess the Preliminary Safety of TK258 400mg Once Daily 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)
This is a phase l study to examine Absorption, Distribution, Metabolism and Excretion of TKI258. There are 2 cohorts. Cohort 1 (4 patients) will receive single radio-labeled 500mg dose of TKI258 followed after 15 days by daily dosing of 400mg TKI258. Cohort 2 (9 patients) will receive 400mg TKI258.
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 |
|---|---|---|---|
| Advanced Solid Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TKI258 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TKI258
- interventionNames
- Drug: TKI258
Primary outcomes (2)
- measure
- Cohort1: Find out about the routes and rates of excretion of TKI258 and its metabolites
- timeFrame
- Day 15
- measure
- Cohort 2: Safety and Tolerability of TKI258
- timeFrame
- Time to patient withdrawal due to disease progression or tolerability issues
Secondary outcomes (3)
- measure
- Cohort 1: Safety and tolerability of TKI258
- timeFrame
- Time to patient withdrawal due to disease progression or tolerability issues
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: 1. Aged ≥ 18 years 2. Patients with histologically confirmed solid tumor or lymphoma who are resistant/refractory to approved therapies or for whom no appropriate therapies are available. 3. WHO performance status ≤ 2 4. All previous treatment (including surgery and radiotherapy) must have been completed at least four weeks prior to study entry and any acute toxicities must have been resolved 5. Written informed consent to participate in the study Exclusion criteria: 1. Primary Brain Tumors or symptomatic leptomeningeal metastases 2. Clinically significant cardiac impairment or unstable ischemic heart disease including a myocardial infarction within six months of study start 3. Fertile males not willing to use contraception or whose female partners are not using adequate contraceptive protection Pregnant or lactating women (all women of childbearing potential must have a negative pregnancy test (\> 5 mIU/ml) before inclusion in the study; post-menopausal women must be amenorrheic for at least 12 months). Female patients must use adequate contraceptive protection 4. Centrally located or squamous cell carcinoma of the lung 5. Proteinuria \> 1+ on dipstick testing 6. History of gastrointestinal malabsorption Surgery involving intestinal anastomosis within four weeks of study start. Other protocol-defined inclusion/exclusion criteria may apply.
References
Publications (1)
- DERIVEDDubbelman AC, Upthagrove A, Beijnen JH, Marchetti S, Tan E, Krone K, Anand S, Schellens JH. Disposition and metabolism of 14C-dovitinib (TKI258), an inhibitor of FGFR and VEGFR, after oral administration in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2012 Nov;70(5):653-63. doi: 10.1007/s00280-012-1947-2. Epub 2012 Aug 22. PMID 23010851