Advanced Solid TumorsTSAPNCT01190241
Targeted Therapy Selection Based on Tumor Tissue Kinase Activity Profiles for Patients With Advanced Solid Malignancies, an Exploratory Study
A study testing desatinib or sunitinib or erlotinib or everolimus or lapatinib or sorafenib in people with Advanced Solid Tumors and Inoperable, run by Amsterdam UMC, location VUmc at 2 sites in Netherlands.
Trial summary
The purpose of this study is to select targeted treatment based on ex vivo kinase activity inhibition profiles to targeted agents of tumor tissue from patients with advanced cancer for whom no standard treatment is available. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Inoperable, Metastasis
- What is being tested?
- desatinib or sunitinib or erlotinib or everolimus or lapatinib or sorafenib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesNetherlands
- Study dates
- Aug 2010to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting with an advanced (unresectable and/or metastatic) solid malignancy for whom no standard treatment is available.
- Patients should have received at least one prior standard medical treatment regimen for their advanced disease.
- Patients with progressive disease within 12 weeks prior to the start of study medication based on radiological assessment.
- At least one tumor lesion should be assessable for biopsy to perform kinase activity analysis.
- Age ≥ 18 years.
- Histological or cytological documentation of cancer is required.
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- Patients with at least one measurable lesion. Lesions must be evaluated by CT-scan or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST).
- WHO performance status 0 - 2
- Life expectancy of at least 12 weeks
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- Hemoglobin ≥ 5.6 mmol/L
- Absolute neutrophil count (ANC) ≥ 1,500/mm3
- Platelet count ≥ 100x10*9/l
- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) 22 of 59
- ALT and AST ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer)
- Serum creatinine ≤ 1.5 x ULN or a calculated creatinine clearance ¡Ý 50 ml/min
- Activated partial thromboplastin time < 1.25 x ULN
- Prothrombin time or INR < 1.25 x ULN
- Patients should be able to swallow oral medication.
- Written informed consent
Who cannot join
- History of cardiac disease:
- Congestive heart failure >NYHA class 2.
- Active Coronary Artery Disease (myocardial infarction more than 6 months prior to screening is allowed).
- Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
- Uncontrolled hypertension. Blood pressure must be ≤ 160/95 mmHg at the time of screening on a stable antihypertensive regimen. Blood pressure must be stable on at least 3 separate measurements on at least 2 separate days.
- Uncontrolled infections (> grade 2 NCI-CTC version 3.0).
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- Subjects with serious non-healing wound, ulcer, or bone fracture.
- History or clinical evidence of central nervous system (CNS) disease, including primary brain tumor and brain metastases.
- Clinical findings associated, in the judgment of the investigator, with an unacceptably high tumor biopsy risk
- Pregnant or breast-feeding subjects.
- Concurrent anticancer chemotherapy, immunotherapy or investigational drug therapy during the study or within 4 weeks of the start of study drug.
- Radiotherapy on target lesions during study or within 4 weeks of the start of study drug. Palliative radiotherapy will be allowed.
- Concomitant use of dexamethasone, anti-convulsants and anti-arrhythmic drugs other than digoxin or beta blockers.
- Major surgery within 28 days of start of treatment. The surgical wound should be fully healed prior to the start of study drug. In subjects who experienced wound healing complications during therapy, treatment should be withheld until the wound is fully healed.
- Substance abuse, medical, psychological or social conditions that may interfere with the subject¡-s participation in the study or evaluation of the study results.
- Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Medical Center Alkmaar
Alkmaar, 1815 JD
VU University Medical Center
Amsterdam, 1081 HV
About this study
The purpose of this study is to select targeted treatment based on ex vivo kinase activity inhibition profiles to targeted agents of tumor tissue from patients with advanced cancer for whom no standard treatment is available.
Read the detailed description
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.
- Conditions
- Advanced Solid Tumors, Inoperable, Metastasis
- Being tested
- desatinib or sunitinib or erlotinib or everolimus or lapatinib or sorafenib
- Keywords
- targeted therapy, individualized medicine, tyrosine kinase inhibitor, kinome profiling, Metastasized
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
desatinib or sunitinib or erlotinib or everolimus or lapatinib or sorafenibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Targeted treatment | Experimental | Targeted treatment with desatinib or sunitinib or erlotinib or everolimus or lapatinib or sorafenib Receives: Drug: desatinib or sunitinib or erlotinib or everolimus or lapatinib or sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The clinical benefit rate (CBR) of this therapy selection approach.
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- VitrOmics BV
- Responsible party
- Principal investigator, M. Labots, Amsterdam UMC, location VUmc
- Investigators
- Henk Verheul, M.D., PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01190241
- Sponsor's protocol ID
- 2010/124
- Acronym
- TSAP
- Status last verified
- Nov 2020
- First submitted
- 26 Aug 2010
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Labots M, Van der Mijn JC, Dekker H, Ruijter R, Pham TV, Van der Vliet HJ, Van der Hoeven JJM, Meijer GA, Verheul HMW. Selection of Protein Kinase Inhibitors Based on Tumor Tissue Kinase Activity Profiles in Patients with Refractory Solid Malignancies: An Interventional Molecular Profiling Study. Oncologist. 2018 Oct;23(10):1135-e118. doi: 10.1634/theoncologist.2018-0263. Epub 2018 Jul 17.
PubMed 30018133
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Therapy Selection Based on Tumor Tissue Kinase Activity Profiles for Patients With Advanced Solid Malignancies, an Exploratory Study
- ClinicalTrials.gov ID
- NCT01190241
- Acronym / sponsor ID
- TSAP / 2010/124
- Conditions
- Advanced Solid Tumors, Inoperable, Metastasis
- Keywords
- targeted therapy, individualized medicine, tyrosine kinase inhibitor, kinome profiling, Metastasized
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- VitrOmics BV
- Study start
- Aug 2010
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 27 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to select targeted treatment based on ex vivo kinase activity inhibition profiles to targeted agents of tumor tissue from patients with advanced cancer for whom no standard treatment is available.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Targeted treatment | Experimental | Drug: desatinib or sunitinib or erlotinib or everolimus or lapatinib or sorafenibTargeted treatment with desatinib or sunitinib or erlotinib or everolimus or lapatinib or sorafenib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Patients presenting with an advanced (unresectable and/or metastatic) solid malignancy for whom no standard treatment is available.
- Patients should have received at least one prior standard medical treatment regimen for their advanced disease.
- Patients with progressive disease within 12 weeks prior to the start of study medication based on radiological assessment.
- At least one tumor lesion should be assessable for biopsy to perform kinase activity analysis.
- Age ≥ 18 years.
Key exclusion criteria (16 listed)
- History of cardiac disease:
- Uncontrolled hypertension. Blood pressure must be ≤ 160/95 mmHg at the time of screening on a stable antihypertensive regimen. Blood pressure must be stable on at least 3 separate measurements on at least 2 separate days.
- Uncontrolled infections (> grade 2 NCI-CTC version 3.0).
- Subjects with serious non-healing wound, ulcer, or bone fracture.
- History or clinical evidence of central nervous system (CNS) disease, including primary brain tumor and brain metastases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| desatinib or sunitinib or erlotinib or everolimus or lapatinib or sorafenibThe 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. | Drug | Targeted treatment |
Primary outcome
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.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Derived from this study: PubMed 30018133Labots M, Van der Mijn JC, Dekker H, Ruijter R, Pham TV, Van der Vliet HJ, Van der Hoeven JJM, Meijer GA, Verheul HMW. Selection of Protein Kinase Inhibitors Based on Tumor Tissue Kinase Activity Profiles in Patients with Refractory Solid Malignancies: An Interventional Molecular Profiling Study. Oncologist. 2018 Oct;23(10):1135-e118. doi: 10.1634/theoncologist.2018-0263. Epub 2018 Jul 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henk Verheul, M.D., PhD principal investigator
Amsterdam UMC, location VUmc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing desatinib or sunitinib or erlotinib or everolimus or lapatinib or sorafenib in people with Advanced Solid Tumors and Inoperable, run by Amsterdam UMC, location VUmc at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clinical benefit rate (CBR) of this therapy selection approach. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01190241, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.