Targeted therapy selection based on tumor tissue kinase activity profiles for patients with advanced solid malignancies, an exploratory study

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-019982-27-NL

Enrollment

Registered

2010-04-29

Start date

2010-07-15

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced (metastasized or inoperable) solid cancer MedDRA version: 12.1 Level: LLT Classification code 10065143 Term: Malignant solid tumour

Interventions

Trade Name: Sutent Product Name: sunitinib Pharmaceutical Form: Capsule, hard INN or Proposed INN: SUNITINIB CAS Number: 557795-19-4 Concentration unit: mg milligram(s) Concentration type: equal Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Advanced solid malignancy, minimum age 18 years, no standard therapeutic options available, life expectancy of at least 12 weeks, measurable disease with at least one lesion assessable for biopsy. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Cardiovascular conditions including congestive heartfailure NYHA class >2, recent myocardial infarction or uncontrolled coronary artery disease, uncontrolled hypertension; uncontrolled infections; anticancer treatment during study or within 4 weeks of start of study treatment.

Design outcomes

Primary

Measure	Time frame
Secondary Objective: 1. To compare progression free survival (PFS) using a kinase inhibitor treatment regimen selected by kinase profiling with the PFS of the most recent treatment regimen on which the patient progressed (i.e., patients are their own controls). 2. To determine the relation of Comparative Genomic Hybridization (CGH)-profiles with response to kinase inhibitors. 3. To determine the relation of serum and tissue kinome proteomic and activity profiles with response to kinase inhibitors and survival. 4. To correlate the frequency and phenotype of immunoregulatory cells in blood and tumor tissue with response to kinase inhibitors. 5. To correlate individual pharmacodynamics with response to kinase inhibitors. ;Primary end point(s): The primary end point is to determine the clinical benefit rate (CBR) of this targeted therapy selection approach, defined by the number of patients demonstrating an objective response (complete or partial response) or stable disease at evaluation after 12 weeks. Available phase I data of the registered kinase inhibitors to be used in this study have shown CBR’s of approximately 10% in patients with advanced solid malignancies excluding renal cell carcinoma, hepatocellular carcinoma and GIST. Based on these data, we expect to increase CBR by ex vivo analysis and therapy selection to 25%. Patients with at least one measurable lesion are eligible for this study. Lesions must be evaluated by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria.;Main Objective: The primary objective is to determine the clinical benefit rate of treatment selection by ex vivo kinase inhibition profiling in tumor tissue of patients with advanced cancer for whom no standard treatment is available.	—

Measure

Time frame

Secondary Objective: 1. To compare progression free survival (PFS) using a kinase inhibitor treatment regimen selected by kinase profiling with the PFS of the most recent treatment regimen on which the patient progressed (i.e., patients are their own controls). 2. To determine the relation of Comparative Genomic Hybridization (CGH)-profiles with response to kinase inhibitors. 3. To determine the relation of serum and tissue kinome proteomic and activity profiles with response to kinase inhibitors and survival. 4. To correlate the frequency and phenotype of immunoregulatory cells in blood and tumor tissue with response to kinase inhibitors. 5. To correlate individual pharmacodynamics with response to kinase inhibitors. ;Primary end point(s): The primary end point is to determine the clinical benefit rate (CBR) of this targeted therapy selection approach, defined by the number of patients demonstrating an objective response (complete or partial response) or stable disease at evaluation after 12 weeks. Available phase I data of the registered kinase inhibitors to be used in this study have shown CBR’s of approximately 10% in patients with advanced solid malignancies excluding renal cell carcinoma, hepatocellular carcinoma and GIST. Based on these data, we expect to increase CBR by ex vivo analysis and therapy selection to 25%. Patients with at least one measurable lesion are eligible for this study. Lesions must be evaluated by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria.;Main Objective: The primary objective is to determine the clinical benefit rate of treatment selection by ex vivo kinase inhibition profiling in tumor tissue of patients with advanced cancer for whom no standard treatment is available.

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026