CancerPhase 1NCT01476085
Evaluating the Utility of the Apoptosis Imaging Biomarker 18F]ML10 in Patients With Non-Hodgkin's Lymphoma(NHL)
A Phase 1 study testing ML10 in people with Cancer, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This study aims to evaluate the potential of 2-(5- Fluoro pentyl)-2-methyl malonic acid ([18F]ML10), as an apoptosis imaging biomarker and its potential to predict response in patients with Non Hodgkin's Lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- ML10
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2011to Oct 2011
- Phase
- Phase 1
- 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
- Capable of giving written informed consent, and willing and able to comply with the requirements and restrictions listed in the consent form.
- Male or female patients >18 years of age at screening with histological or cytological diagnosis of Non-Hodgkin's Lymphoma and due to receive intravenous chemotherapy for the first time
- A female subject is eligible to participate if she has non-childbearing potential
- Male subject must agree to use one of the contraception methods listed
- Able to lie comfortably on back for up to 70 minutes at a time.
- WHO performance status 0, 1 or 2 -
Who cannot join
- Patients with known history of Hepatitis B, C, non-A, non-B and HIV
- Any clinically significant medical conditions that in the opinion of the investigator would compromise the compliance with study procedures.
- Pregnant or breast feeding females.
- Any other prior anticancer therapy
- Any new investigational agent, including an investigational anti-cancer agent
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Males and females not able to comply with contraceptive guidelines during the study.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Study to Evaluate the Utility of the Apoptosis Imaging Biomarker 18F]ML10 to Assess the Response to Chemotherapy in Patients With Non-Hodgkin's Lymphoma(NHL).
This study aims to evaluate the potential of 2-(5- Fluoro pentyl)-2-methyl malonic acid ([18F]ML10), as an apoptosis imaging biomarker and its potential to predict response in patients with Non Hodgkin's Lymphoma.
Read the detailed description
Apoptosis or programmed cell death mechanisms are disrupted in cancer cells allowing them to live longer and grow faster than normal cells. Apoptosis is a key target for several novel anti-cancer agents. A biomarker that could permit imaging levels of ongoing apoptosis could be a powerful tool in associated drug development programs by providing relevant data to support proof of concept. In addition, use in the clinical setting may permit the tailoring of treatment for individual patients balancing efficacy of treatment with known toxicity levels. This study aims to evaluate the potential of 2-(5- Fluoro pentyl)-2-methyl malonic acid ([18F]ML10), as an apoptosis imaging biomarker and its potential to predict response in patients with Non Hodgkin's Lymphoma. All patients will have a baseline [18F]ML10 PET-CT scan and a post-treatment scan after the initiation of the first course of intravenous chemotherapy. The study aims to enrol unto 16 subjects with Non-Hodgkins Lymphoma.
- Conditions
- Cancer
- Being tested
- ML10
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ML10Radiation
[18F]ML10 radioligand apoptosis biomarker
| Study group | Role | What they receive |
|---|---|---|
| no treatment | No intervention | no treatment Receives: Radiation: ML10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in [18F]ML10 uptake in tumours
Extent of changes in [18F]ML10 uptake in tumours following chemotherapy using visual and semi-quantitative parameters.
Measured: between baseline at day 0 and between 14-20 days after
Secondary outcomes (2)
alterations in [18F]ML10 uptake with tumour volume and tumour metabolic changes
Relationship between alterations in [18F]ML10 uptake with tumour volume and tumour metabolic changes in response to chemotherapy as measured by standard of care CT scan and FDG PET scan.
Measured: between baseline at day 0 and between 14-20 days after
voxel-based uptake map of [18F]ML10 in the target lesion
Alterations in the voxel-based uptake map of [18F]ML10 in the target lesion in response to the chemotherapy.
Measured: between baseline at day 0 and between 14-20 days after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startJul 2011
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: Study terminated as ongoing analysis suggested objectives not practical to achieve with study as implemented
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 GlaxoSmithKlineThe 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476085
- Sponsor's protocol ID
- 114238
- Status last verified
- Jun 2013
- First submitted
- 1 Sep 2011
- Last updated
- 1 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Evaluate the Utility of the Apoptosis Imaging Biomarker 18F]ML10 to Assess the Response to Chemotherapy in Patients With Non-Hodgkin's Lymphoma(NHL).
- ClinicalTrials.gov ID
- NCT01476085
- Acronym / sponsor ID
- 114238
- Conditions
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated as ongoing analysis suggested objectives not practical to achieve with study as implemented
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 22 Nov 2011 (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.
This study aims to evaluate the potential of 2-(5- Fluoro pentyl)-2-methyl malonic acid ([18F]ML10), as an apoptosis imaging biomarker and its potential to predict response in patients with Non Hodgkin's Lymphoma.
Detailed description
Apoptosis or programmed cell death mechanisms are disrupted in cancer cells allowing them to live longer and grow faster than normal cells. Apoptosis is a key target for several novel anti-cancer agents. A biomarker that could permit imaging levels of ongoing apoptosis could be a powerful tool in associated drug development programs by providing relevant data to support proof of concept. In addition, use in the clinical setting may permit the tailoring of treatment for individual patients balancing efficacy of treatment with known toxicity levels. This study aims to evaluate the potential of 2-(5- Fluoro pentyl)-2-methyl malonic acid ([18F]ML10), as an apoptosis imaging biomarker and its potential to predict response in patients with Non Hodgkin's Lymphoma. All patients will have a baseline [18F]ML10 PET-CT scan and a post-treatment scan after the initiation of the first course of intravenous chemotherapy. The study aims to enrol unto 16 subjects with Non-Hodgkins Lymphoma.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no treatment | No intervention | Radiation: ML10no treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Capable of giving written informed consent, and willing and able to comply with the requirements and restrictions listed in the consent form.
- Male or female patients >18 years of age at screening with histological or cytological diagnosis of Non-Hodgkin's Lymphoma and due to receive intravenous chemotherapy for the first time
- A female subject is eligible to participate if she has non-childbearing potential
- Male subject must agree to use one of the contraception methods listed
- Able to lie comfortably on back for up to 70 minutes at a time.
Key exclusion criteria (8 listed)
- Patients with known history of Hepatitis B, C, non-A, non-B and HIV
- Any clinically significant medical conditions that in the opinion of the investigator would compromise the compliance with study procedures.
- Pregnant or breast feeding females.
- Any other prior anticancer therapy
- Any new investigational agent, including an investigational anti-cancer agent
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 |
|---|---|---|
| ML10[18F]ML10 radioligand apoptosis biomarker | Radiation | no treatment |
Primary outcome
changes in [18F]ML10 uptake in tumours
Time frame: between baseline at day 0 and between 14-20 days after
Extent of changes in [18F]ML10 uptake in tumours following chemotherapy using visual and semi-quantitative parameters.
2 secondary outcomes
alterations in [18F]ML10 uptake with tumour volume and tumour metabolic changes
Time frame: between baseline at day 0 and between 14-20 days after
voxel-based uptake map of [18F]ML10 in the target lesion
Time frame: between baseline at day 0 and between 14-20 days after
Results and safety
The study was stopped early (reason given: Study terminated as ongoing analysis suggested objectives not practical to achieve with study as implemented). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2013.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ML10 in people with Cancer, run by GlaxoSmithKline at 1 site in United Kingdom.
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 6 inclusion and 8 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 1 Jul 2013. 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 United Kingdom. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study terminated as ongoing analysis suggested objectives not practical to achieve with study as implemented). 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?
changes in [18F]ML10 uptake in tumours (time frame: between baseline at day 0 and between 14-20 days after). 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 1 Jul 2013.