Metastatic MalignanciesMabtornibNCT00657098
Side Effects of Vascular Endothelial Growth Factor (VEGF) and Epidermal Growth Factor Receptor (EGFR) Directed Therapy
An observational study of Metastatic Malignancies, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Angiogenesis inhibitors and EGFR inhibitors not only have anti tumor activity but also modify physiological processes. This study evaluates effects on vascular function, endocrine function and metabolism. Changes in these parameters will be analysed for predictive value for treatment efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Malignancies
- How many people
- 73 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2008to Oct 2015
- Phase
- Observational
- 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
Study population: Patients who will be treated with angiogenesis inhibitors or EGFR inhibitors
Who may be able to join
- Patients who will start with an angiogenesis inhibitor or EGFR inhibitor
- Concomittant chemotherapy, immunotherapy or radiotherapy is allowed
- Age above 18 years at start of treatment
- Willingness to give written informed consent
Who cannot join
- Unable to give written informed consent
- Age under 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mabtornib Protocol.Vascular, Metabolic and Hormonal Effects of Angiogenesis Inhibitors and Epidermal Growth Factor Receptor Inhibitors
Angiogenesis inhibitors and EGFR inhibitors not only have anti tumor activity but also modify physiological processes. This study evaluates effects on vascular function, endocrine function and metabolism. Changes in these parameters will be analysed for predictive value for treatment efficacy.
Read the detailed description
Background
In recent years, multiple new agents have been developed that inhibit angiogenesis and the epidermal growth factor receptor (EGFR) signalling pathway.
The cell signalling routes that are inhibited by these agents however are not only active in tumour formation but are also involved in physiological processes in normal tissue and organs. This means that these drugs do not only have an anti tumour effect but also modify several physiological processes that lead to side effects. Little is known about these side effects that generally are less severe than side effects of cytotoxic chemotherapy, but because targeted therapy is often administered for prolonged periods of time, these side effects can seriously affect quality of life.
Objectives
Primary objectives
- To determine the characteristics, frequency and severity of vascular, metabolic and hormonal side effects of angiogenesis and EGFR inhibitors.
Secondary objectives
- To investigate if steroid profile, indol profile, concentrations of catecholamines and metanephrines or thyroid antibodies change during treatment with angiogenesis and EGFR inhibitors.
- To investigate if known biomarkers change during treatment.
- To investigate whether vascular function changes during treatment with angiogenesis and EGFR inhibitors.
- To determine if changes in skin autofluorescence and development of AGE's occur during treatment with angiogenesis and EGFR inhibitors.
- To determine whether changes in factors mentioned under secondary objectives 1-4 are correlated with side effects of targeted therapy and/or response to angiogenesis and EGFR inhibitors.
- To evaluate if polymorphisms in genes involved in pathways mentioned under 1-4 associate with toxicity and efficacy of angiogenesis and EGFR inhibitors.
Study design and population
This is a prospective, explorative observational cohort study in patients treated with angiogenesis or EGFR inhibitors. Concomitant chemotherapy, immunotherapy or radiotherapy is allowed. Patients must be 18 years or older at start of treatment and must be willing to give written informed consent.
Primary study parameters
Patients will be evaluated for vascular changes by measuring
- 24-hour ambulatory blood pressure
- nail fold capillary microscopy
- skin autofluorescence at 3 time points: before start of treatment, and after 3 and after 6 weeks of treatment. Patients will also be asked to measure their blood pressure at home twice a day, for 6 weeks. Metabolic and hormonal changes and investigation of biomarkers will be done by blood and urine analyses every 3 weeks for the first 3 months, every 6 weeks up to 6 months and every 3 months thereafter.
Changes in vascular, hormonal and metabolic status will be related to clinical side effects and to response to treatment.
Secondary study parameters
When clinically relevant differences in side effects and response to treatment are found among patients treated with the same agent, DNA analysis will be carried out to investigate if changes in candidate genes are related to these differences.
Burden and risks associated with participation, benefit and group relatedness
The minimal invasive tests will be performed during routine outpatient visits. As far as known no serious adverse events are linked to the described study procedures. With this study we hope to get insight into the characteristics, frequency, severity and underlying mechanisms of angiogenesis and EGFR inhibitor induced vascular, metabolic and hormonal side effects and to find usable surrogate markers for efficacy of treatment. Eventually, this may contribute to the early detection of vascular, metabolic and hormonal changes, to the design of intervention strategies for side effects and to better patient selection for angiogenesis and EGFR inhibition.
- Conditions
- Metastatic Malignancies
- Keywords
- Side effects, Angiogenesis inhibitors, Epidermal growth factor receptor inhibitors, Tyrosinekinase inhibitors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics, frequency and severity of vascular, metabolic and hormonal side effects of angiogenesis and EGFR inhibitors.
Vascular function tests at baseline, after 3 and after 6 weeks of treatment, blood and urine measurements as long as treatment is continued.
Measured: after 3 and after 6 weeks of treatment
Secondary outcomes (1)
DNA analysis
Measured: day -7 till day -1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionOct 2015
- Study completionOct 2015
Why it stopped: slow inclusion rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MalignanciesStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jourik A Gietema, MD/PhD, Principal investigator, University Medical Center Groningen, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657098
- Sponsor's protocol ID
- 2007/203
- Acronym
- Mabtornib
- Status last verified
- May 2024
- First submitted
- 8 Apr 2008
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mabtornib Protocol.Vascular, Metabolic and Hormonal Effects of Angiogenesis Inhibitors and Epidermal Growth Factor Receptor Inhibitors
- ClinicalTrials.gov ID
- NCT00657098
- Acronym / sponsor ID
- Mabtornib / 2007/203
- Conditions
- Metastatic Malignancies
- Keywords
- Side effects, Angiogenesis inhibitors, Epidermal growth factor receptor inhibitors, Tyrosinekinase inhibitors
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: slow inclusion rate
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 14 Apr 2008 (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.
Angiogenesis inhibitors and EGFR inhibitors not only have anti tumor activity but also modify physiological processes. This study evaluates effects on vascular function, endocrine function and metabolism. Changes in these parameters will be analysed for predictive value for treatment efficacy.
Detailed description
Background
In recent years, multiple new agents have been developed that inhibit angiogenesis and the epidermal growth factor receptor (EGFR) signalling pathway.
The cell signalling routes that are inhibited by these agents however are not only active in tumour formation but are also involved in physiological processes in normal tissue and organs. This means that these drugs do not only have an anti tumour effect but also modify several physiological processes that lead to side effects. Little is known about these side effects that generally are less severe than side effects of cytotoxic chemotherapy, but because targeted therapy is often administered for prolonged periods of time, these side effects can seriously affect quality of life.
Objectives
Primary objectives
- To determine the characteristics, frequency and severity of vascular, metabolic and hormonal side effects of angiogenesis and EGFR inhibitors.
Secondary objectives
- To investigate if steroid profile, indol profile, concentrations of catecholamines and metanephrines or thyroid antibodies change during treatment with angiogenesis and EGFR inhibitors.
- To investigate if known biomarkers change during treatment.
- To investigate whether vascular function changes during treatment with angiogenesis and EGFR inhibitors.
- To determine if changes in skin autofluorescence and development of AGE's occur during treatment with angiogenesis and EGFR inhibitors.
- To determine whether changes in factors mentioned under secondary objectives 1-4 are correlated with side effects of targeted therapy and/or response to angiogenesis and EGFR inhibitors.
- To evaluate if polymorphisms in genes involved in pathways mentioned under 1-4 associate with toxicity and efficacy of angiogenesis and EGFR inhibitors.
Study design and population
This is a prospective, explorative observational cohort study in patients treated with angiogenesis or EGFR inhibitors. Concomitant chemotherapy, immunotherapy or radiotherapy is allowed. Patients must be 18 years or older at start of treatment and must be willing to give written informed consent.
Primary study parameters
Patients will be evaluated for vascular changes by measuring
- 24-hour ambulatory blood pressure
- nail fold capillary microscopy
- skin autofluorescence at 3 time points: before start of treatment, and after 3 and after 6 weeks of treatment. Patients will also be asked to measure their blood pressure at home twice a day, for 6 weeks. Metabolic and hormonal changes and investigation of biomarkers will be done by blood and urine analyses every 3 weeks for the first 3 months, every 6 weeks up to 6 months and every 3 months thereafter.
Changes in vascular, hormonal and metabolic status will be related to clinical side effects and to response to treatment.
Secondary study parameters
When clinically relevant differences in side effects and response to treatment are found among patients treated with the same agent, DNA analysis will be carried out to investigate if changes in candidate genes are related to these differences.
Burden and risks associated with participation, benefit and group relatedness
The minimal invasive tests will be performed during routine outpatient visits. As far as known no serious adverse events are linked to the described study procedures. With this study we hope to get insight into the characteristics, frequency, severity and underlying mechanisms of angiogenesis and EGFR inhibitor induced vascular, metabolic and hormonal side effects and to find usable surrogate markers for efficacy of treatment. Eventually, this may contribute to the early detection of vascular, metabolic and hormonal changes, to the design of intervention strategies for side effects and to better patient selection for angiogenesis and EGFR inhibition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will be treated with angiogenesis inhibitors or EGFR inhibitors
Key inclusion criteria (4 listed)
- Patients who will start with an angiogenesis inhibitor or EGFR inhibitor
- Concomittant chemotherapy, immunotherapy or radiotherapy is allowed
- Age above 18 years at start of treatment
- Willingness to give written informed consent
Key exclusion criteria (2 listed)
- Unable to give written informed consent
- Age under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characteristics, frequency and severity of vascular, metabolic and hormonal side effects of angiogenesis and EGFR inhibitors.
Time frame: after 3 and after 6 weeks of treatment
Vascular function tests at baseline, after 3 and after 6 weeks of treatment, blood and urine measurements as long as treatment is continued.
1 secondary outcome
DNA analysis
Time frame: day -7 till day -1
Results and safety
The study was stopped early (reason given: slow inclusion rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
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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.
Jourik A Gietema, MD/PhD principal investigator
University Medical Center Groningen, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Malignancies, run by University Medical Center Groningen 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 2 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 3 May 2024. 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 was stopped early (reason given: slow inclusion rate). 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?
Characteristics, frequency and severity of vascular, metabolic and hormonal side effects of angiogenesis and EGFR inhibitors. (time frame: after 3 and after 6 weeks of treatment). 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 3 May 2024.