CancerICKNCT01636908
Determination of Intratumoral Concentrations of Kinase Inhibitors in Patients With Advanced Solid Malignancies.
A study testing Sunitinib, Sorafenib and Erlotinib in people with Cancer and Advanced Solid Tumors, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine intratumoral concentration of kinase inhibitors upon 2 weeks of treatment in tumor tissue of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Advanced Solid Tumors
- What is being tested?
- Sunitinib, Sorafenib and Erlotinib
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2011to 1 Dec 2019
- 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
- Advanced solid malignancy
- minimum age 18 years
- indication for palliative treatment
- measurable disease with at least one lesion accessable for biopsy
Who cannot join
- Cardiovascular conditions including congestive heartfailure NYHA class >2
- recent myocardial infarction or uncontrolled coronary artery disease
- cardiac arrhythmias requiring anti-arrhythmic therapy
- uncontrolled hypertension
- uncontrolled infections
- serious non-healing wound, ulcer or bone fracture
- pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study on the Determination of Intratumoral Concentrations of Kinase Inhibitors in Patients With Advanced Solid Malignancies.
The purpose of this study is to determine intratumoral concentration of kinase inhibitors upon 2 weeks of treatment in tumor tissue of patients.
Read the detailed description
Patients will be cohort-wise treated with clinically available kinase inhibitors for 2 weeks prior to standard palliative treatment. Five patients will be included in each of eight drug cohorts. Biopsies will be performed to determine intratumoral drug concentrations and to compare tissue (phospho)proteomic and kinase activity profiles before and during therapy.
- Conditions
- Cancer, Advanced Solid Tumors
- Being tested
- Sunitinib, Sorafenib, Erlotinib, Everolimus, Lapatinib
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunitinibDrug
50 mg once daily, oral use, 14 days
SorafenibDrug
400 mg, twice daily, oral use, 14 days
ErlotinibDrug
150 mg once daily, oral use, 14 days
EverolimusDrug
10 mg once daily, oral use, 14 days
LapatinibDrug
1250 mg once daily, oral use, 14 days
DasatinibDrug
100 mg once daily, oral use, 14 days
PazopanibDrug
800 mg once daily, oral use, 14 days
VemurafenibDrug
960 mg twice daily, oral use, 15-21 days
tumor biopsyProcedure or surgery
skin biopsy (optional)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Kinase inhibitor | Experimental | Patients are cohort-wise treated with a registered (tyrosine) kinase inhibitor Receives: Drug: Sunitinib; Drug: Sorafenib; Drug: Erlotinib; Drug: Everolimus; Drug: Lapatinib; Drug: Dasatinib; Drug: Pazopanib; Drug: Vemurafenib; Procedure: tumor biopsy; Procedure: skin biopsy (optional) |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentrations of intratumoral kinase inhibitors upon 2 weeks of treatment
Measured: 2 weeks
Secondary outcomes (4)
kinase inhibitor concentrations in plasma, serum and PBMC's upon 2 weeks of treatment
Measured: 2 weeks
intra-dermal kinase inhibitor concentrations upon 2 weeks of treatment
Measured: 2 weeks
To determine per patient whether 2 weeks of treatment with kinase inhibitors induces significant change of phosphoproteomic profiles in tumor tissue
Measured: 2 weeks
To determine per patient whether 2 weeks of treatment with kinase inhibitors induces significant change of kinase activity in tumor tissue
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startAug 2011
- Primary completion1 Jan 2018
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Labots, Amsterdam UMC, location VUmc
- Investigators
- H.M.W. Verheul, MD, PhD, Principal investigator, VU Medical Center Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636908
- Sponsor's protocol ID
- 2011/128
- Acronym
- ICK
- Status last verified
- Apr 2021
- First submitted
- 5 Jul 2012
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Determination of Intratumoral Concentrations of Kinase Inhibitors in Patients With Advanced Solid Malignancies.
- ClinicalTrials.gov ID
- NCT01636908
- Acronym / sponsor ID
- ICK / 2011/128
- Conditions
- Cancer, Advanced Solid Tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- Aug 2011 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 10 Jul 2012 (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 determine intratumoral concentration of kinase inhibitors upon 2 weeks of treatment in tumor tissue of patients.
Detailed description
Patients will be cohort-wise treated with clinically available kinase inhibitors for 2 weeks prior to standard palliative treatment. Five patients will be included in each of eight drug cohorts. Biopsies will be performed to determine intratumoral drug concentrations and to compare tissue (phospho)proteomic and kinase activity profiles before and during therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kinase inhibitor | Experimental | Drug: Sunitinib, Drug: Sorafenib, Drug: Erlotinib, Drug: Everolimus, Drug: Lapatinib, Drug: Dasatinib, Drug: Pazopanib, Drug: Vemurafenib, Procedure: tumor biopsy, Procedure: skin biopsy (optional)Patients are cohort-wise treated with a registered (tyrosine) kinase inhibitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Advanced solid malignancy
- minimum age 18 years
- indication for palliative treatment
- measurable disease with at least one lesion accessable for biopsy
Key exclusion criteria (7 listed)
- Cardiovascular conditions including congestive heartfailure NYHA class >2
- recent myocardial infarction or uncontrolled coronary artery disease
- cardiac arrhythmias requiring anti-arrhythmic therapy
- uncontrolled hypertension
- uncontrolled infections
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 |
|---|---|---|
| Sunitinib50 mg once daily, oral use, 14 days | Drug | Kinase inhibitor |
| Sorafenib400 mg, twice daily, oral use, 14 days | Drug | Kinase inhibitor |
| Erlotinib150 mg once daily, oral use, 14 days | Drug | Kinase inhibitor |
| Everolimus10 mg once daily, oral use, 14 days | Drug | Kinase inhibitor |
| Lapatinib1250 mg once daily, oral use, 14 days | Drug | Kinase inhibitor |
| Dasatinib100 mg once daily, oral use, 14 days | Drug | Kinase inhibitor |
| Pazopanib800 mg once daily, oral use, 14 days | Drug | Kinase inhibitor |
| Vemurafenib960 mg twice daily, oral use, 15-21 days | Drug | Kinase inhibitor |
| tumor biopsy | Procedure or surgery | Kinase inhibitor |
| skin biopsy (optional) | Procedure or surgery | Kinase inhibitor |
Primary outcome
concentrations of intratumoral kinase inhibitors upon 2 weeks of treatment
Time frame: 2 weeks
4 secondary outcomes
kinase inhibitor concentrations in plasma, serum and PBMC's upon 2 weeks of treatment
Time frame: 2 weeks
intra-dermal kinase inhibitor concentrations upon 2 weeks of treatment
Time frame: 2 weeks
To determine per patient whether 2 weeks of treatment with kinase inhibitors induces significant change of phosphoproteomic profiles in tumor tissue
Time frame: 2 weeks
To determine per patient whether 2 weeks of treatment with kinase inhibitors induces significant change of kinase activity in tumor tissue
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
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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.
H.M.W. Verheul, MD, PhD principal investigator
VU Medical Center Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sunitinib, Sorafenib and Erlotinib in people with Cancer and Advanced Solid Tumors, run by Amsterdam UMC, location VUmc at 1 site 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
concentrations of intratumoral kinase inhibitors upon 2 weeks of treatment (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2021.