Targeted Therapy Selection Based on Tumor Tissue Kinase Activity Profiles for Patients With Advanced Solid Malignancies, an Exploratory Study (TSAP)
|ClinicalTrials.gov Identifier: NCT01190241|
Recruitment Status : Unknown
Verified June 2015 by VU University Medical Center.
Recruitment status was: Active, not recruiting
First Posted : August 27, 2010
Last Update Posted : June 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumors Inoperable Metastasis||Drug: desatinib or sunitinib or erlotinib or everolimus or lapatinib or sorafenib||Not Applicable|
Specific signalling proteins that are important for tumor growth can be targeted by agents. These are called targeted agents or targeted treatment. Thus far, it is unclear which patients will respond to these targeted agents. It is assumed that responses to these agents depend on specific receptor and protein signalling activities in tumor tissues. The investigators propose that kinase activity profiling may be a potential clinical diagnostic tool to predict tumor response to targeted treatment with tyrosine kinase inhibitors.
The investigators will determine ex vivo kinase activity inhibition profiles of tumor tissue to different targeted agents. Tumor tissue from patients with advanced cancer for whom no standard treatment is available will be used.
Patients will be treated with the selected targeted agent and the clinical benefit will be determined.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Targeted Therapy Selection Based on Tumor Tissue Kinase Activity Profiles for Patients With Advanced Solid Malignancies, an Exploratory Study|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||May 2016|
Experimental: Targeted treatment
Targeted treatment with desatinib or sunitinib or erlotinib or everolimus or lapatinib or sorafenib
Drug: desatinib or sunitinib or erlotinib or everolimus or lapatinib or sorafenib
The drug will be selected based on ex vivo test on the tumor tissue. The patients will be treated with the selected drug until disease progression.
- The clinical benefit rate (CBR) of this therapy selection approach. [ Time Frame: 12 weeks ]The clinical benefit rate (CBR) is defined by the number of patients demonstrating either a complete or partial response or stable disease after 12 weeks of treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01190241
|Medical Center Alkmaar|
|Alkmaar, Netherlands, 1815 JD|
|VU University Medical Center|
|Amsterdam, Netherlands, 1081 HV|
|Principal Investigator:||Henk Verheul, M.D., PhD||VU University Medical Center|