Clinical trial · Observational
Biomarker Development for Response Prediction by DNA Mutational Analysis
Feasibility Study of Biomarker Development for Response Prediction by Large Scale DNA Mutational Analysis of Metastatic Lesions
NCT01855061CI-TRIAL-00031998CPCT-01terminatedClinicalTrials.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 this study is to determine whether it is possible to predict response to chemotherapy in patients with metastatic cancer who are treated with irinotecan by determining the mutational profile of the tumor.
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 |
|---|---|---|---|
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy | Procedure | — | UNRESOLVED |
| Blood samples | Procedure | — | UNRESOLVED |
| Midazolam clearance test | Procedure | — | UNRESOLVED |
| Pharmacokinetics | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Irinotecan
- description
- Patients will be subjected to a their metastatic solid tumor. Radiological response will be evaluated after each 2 cycles: 1. percentage change in radiological volume of the "index lesion" (radiological measurable lesion that underwent biopsy) after the first two cycles of irinotecan; 2. radiological response according to RECIST 1.1 after each 2 cycles. Patients are intended to receive irinotecan until progressive disease or unacceptable toxicity. Patients will be subjected to another biopsy of the index lesion at definitive discontinuation of irinotecan. Patients will also be subjected to blood draws for determining patient's genetic background variation. Side studies include: * pharmacogenetics * pharmacokinetics of SN-38 * carboxylesterase activity in the index lesion * midazolam clearance test (only in Rotterdam patients)
- interventionNames
- Procedure: Biopsy
- Procedure: Blood samples
- Procedure: Pharmacokinetics
- Procedure: Midazolam clearance test
Primary outcomes (1)
- measure
- Exploration of the correlation between the mutational profile and the percentage change in volumetric measurement of the index lesion after the first two cycles of chemotherapy.
- timeFrame
- Change in radiological volume of the index lesion after the first 2 cycles of irinotecan. Radiological response (according to RECIST 1.1) after the first 2 cycles of irinotecan (i.e. after 2 x 3 weeks = 6 weeks)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
1. Patients with a metastatic solid tumor who have failed at least one line of palliative chemotherapy and are irinotecan naïve.
2. Patients who are, as per local protocol, eligible for palliative treatment with (standard of care) irinotecan.
3. Measurable metastatic lesion(s), according to RECIST 1.1 criteria.
4. Radiological measurable metastatic lesion(s) of which a histological biopsy can safely be obtained:
1. Patients with safely accessible metastases.
2. Patients not known with bleeding disorders (such as hemophilia) or bleeding complications from biopsies, dental procedures or surgeries.
3. Patients not using any anti-coagulant medication at the time of biopsy: all aspirin derivatives, NSAID's, coumarines, platelet function inhibitors, heparins (including LMWHs) and oral factor Xa inhibitors are not allowed, unless medication can either be safely stopped or counteracted.
4. Adequate coagulation status on the day of biopsy as measured by:
* PTT \< 1.5 x ULN
* APTT \< 1.5 x ULN
* Platelet count 100 x 10\*9 / L or higher
* PT-INR \< 1.6
* HB \> 6
5. Biopsies should be performed at least four weeks after last bevacizumab administration.
5. Patients age 18 years or up, willing and able to comply with the protocol as judged by the investigator with a signed informed consent.
Exclusion Criteria:
Patients not meeting all of the above inclusion criteria.References
Publications (0)
Data not yet available
No reference posted for this study.