Clinical trial · Observational
Appropriate Dosing to Optimise Personalised Cancer Treatments
NCT04154163CI-TRIAL-00056792ADOPTcompletedClinicalTrials.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)
This is a pilot study to assess feasibility of dried blood spot (DBS) samples for pharmacokinetic measurements of targeted anti-cancer drugs in oncology patients such as patients with BRAF-mutant melanoma receiving targeted treatment with BRAF and MEK inhibitors.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer, Non-small Cell | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Melanoma Stage III | Melanoma | CURATED_BROADER | 0.78 |
| Melanoma Stage IV | Melanoma | CURATED_BROADER | 0.78 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Renal Cancer Stage III | — | UNRESOLVED | — |
| Renal Cancer Stage IV | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dried blood Spot (DBS) | Diagnostic Test | — | UNRESOLVED |
| Venous blood sampling | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Stage 1 Participants
- description
- Blood test Day 1 DBS and venous blood Blood test Day 2 DBS (+/- and venous blood) Blood test Day 15 DBS only Blood test Day 16 DBS only
- interventionNames
- Diagnostic Test: Dried blood Spot (DBS)
- Diagnostic Test: Venous blood sampling
- label
- Stage 2 Participants
- description
- Non-drug naive participants: Blood test Day 1 DBS Blood test Day 2 DBS Blood test Day 15 DBS Blood test Day 16 DBS Drug naive participants: Blood test Day 1 DBS Blood test Day 2 DBS Blood test Day 3, 4, or 5 DBS Blood test Day 4, 5 or 6 DBS Blood test Day 15 DBS Blood test Day 16 DBS
- interventionNames
- Diagnostic Test: Dried blood Spot (DBS)
Primary outcomes (1)
- measure
- The accuracy of DBS for measuring drug levels in venous blood following standard doses of targeted therapies for metastatic cancers such as BRAF mutant melanoma
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female participants * Age 18 years and over * Confirmed diagnosis of stage 4 or stage 3 unresectable cancers; BRAF+ melanoma, c-KIT+ melanoma, advanced renal cell carcinoma, non-small cell lung carcinoma and ovarian carcinoma. * Able to perform study assessments * Individuals who are participating in the follow-up phase of another interventional trial/study, or who are enrolled in an observational study, will be co-enrolled where the CIs of each study agree that it is appropriate Exclusion Criteria: * Inability to give informed consent * World Health Organisation (WHO) performance status 3-4 * Known allergy or intolerance to Dabrafenib +/- Trametinib, Prazopanib, Erlotinib, Gefitinib, Imatinib, Osimertinib or Olaparib * Unstable co-morbidities; cardiovascular disease e.g. severe congestive cardiac failure, end stage renal failure, hepatic impairment, vasculopathy, inflammatory arthritis or interstitial lung disease/ pneumonitis which, in the opinion of the CI, would make the patient unsuitable to be enrolled in the study * Language barrier preventing adequate understanding of the study and a lack of suitable translator service to overcome this barrier * Pregnancy
References
Publications (5)
- BACKGROUNDRobijns K, Koster RA, Touw DJ. Therapeutic drug monitoring by dried blood spot: progress to date and future directions. Clin Pharmacokinet. 2014 Nov;53(11):1053. doi: 10.1007/s40262-014-0197-3. No abstract available. PMID 25312497
- BACKGROUNDde Wit D, den Hartigh J, Gelderblom H, Qian Y, den Hollander M, Verheul H, Guchelaar HJ, van Erp NP. Dried blood spot analysis for therapeutic drug monitoring of pazopanib. J Clin Pharmacol. 2015 Dec;55(12):1344-50. doi: 10.1002/jcph.558. Epub 2015 Jul 14. PMID 26032288
- BACKGROUNDNijenhuis CM, Huitema AD, Marchetti S, Blank C, Haanen JB, van Thienen JV, Rosing H, Schellens JH, Beijnen JH. The Use of Dried Blood Spots for Pharmacokinetic Monitoring of Vemurafenib Treatment in Melanoma Patients. J Clin Pharmacol. 2016 Oct;56(10):1307-12. doi: 10.1002/jcph.728. Epub 2016 Apr 8. PMID 26918324
- BACKGROUNDOuellet D, Gibiansky E, Leonowens C, O'Hagan A, Haney P, Switzky J, Goodman VL. Population pharmacokinetics of dabrafenib, a BRAF inhibitor: effect of dose, time, covariates, and relationship with its metabolites. J Clin Pharmacol. 2014 Jun;54(6):696-706. doi: 10.1002/jcph.263. Epub 2014 Jan 17. PMID 24408395
- BACKGROUNDFriedl B, Kurlbaum M, Kroiss M, Fassnacht M, Scherf-Clavel O. A method for the minimally invasive drug monitoring of mitotane by means of volumetric absorptive microsampling for a home-based therapeutic drug monitoring. Anal Bioanal Chem. 2019 Jul;411(17):3951-3962. doi: 10.1007/s00216-019-01868-1. Epub 2019 May 16. PMID 31093700