CancerPhase 2NCT01428440
PET Study to Study Tumour Apoptosis
A Phase 2 study testing 18FML10 in people with Cancer, run by GlaxoSmithKline at 2 sites in United Kingdom.
Trial summary
Apoptosis or programmed cell death is disrupted in cancer cells allowing them to live longer. A number of anti-cancer agents induce apoptosis as a mechanism of drug action to get rid of cancers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- 18FML10
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Dec 2009to Jul 2011
- Phase
- Phase 2
- 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
- Male or female patients >18 years of age at screening with histological or cytological diagnosis of non-Hodgkin's lymphoma, small cell lung cancer, breast or ovarian cancer who have been worked up clinically (see below) and due to receive standard chemotherapy treatment, but enrolled prior to the initiation of chemotherapy.
- A female subject is eligible to participate if she is of non-childbearing potential or if she is of childbearing potential and agrees to use one of the contraception methods listed. Male subjects are eligible to participate if he also agrees to use one of the contraception methods listed.
- Tumour that is considered by the investigator to be able to be imaged using PET (about 2cm in size or more)
- Able to lie comfortably on back for up to 65 minutes at a time.
- Capable of giving written informed consent, and willing and able to comply with the requirements and restrictions listed in the consent form.
- Patients deemed to be fit to receive chemotherapy treatment by their oncologist.
- WHO performance status 0, 1 or 2.
Who cannot join
- Any medical or psychiatric diagnoses or symptoms or social situations that in the view of the investigator would limit compliance with study requirements.
- Pregnant or breast feeding females.
- Received any other anticancer therapy (radiotherapy, chemotherapy, or immunotherapy) or any other investigational agent, including an investigational anti-cancer agent within 28 days prior to the first [18F]ML10-PET scan.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Inability to comply with contraceptive guidelines during the study.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
GSK Investigational Site
London, London, W12 0NN
GSK Investigational Site
London, SE1 9RT
About this study
Official title: A Positron Emission Tomography (PET) Study to Evaluate 18FML10 as an Imaging Agent for Tumour Apoptosis
Apoptosis or programmed cell death is disrupted in cancer cells allowing them to live longer. A number of anti-cancer agents induce apoptosis as a mechanism of drug action to get rid of cancers. A biomarker that would allow apoptosis in tumours to be imaged directly would provide a powerful new tool for oncology drug development and potentially contribute to improved patient care. In this study, we propose to evaluate [18F]ML10-PET for imaging tumour apoptosis in patients receiving standard chemotherapy treatment for their cancer.
- Conditions
- Cancer
- Being tested
- 18FML10
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18FML10Radiation
apoptosis imaging radio ligand
| Study group | Role | What they receive |
|---|---|---|
| no treatment | Other | Not described Receives: Radiation: 18FML10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apoptosis imaging
Evaluate feasibility of apoptosis imaging with [18F]ML10 PET/CT in
Measured: 2.5 years
Secondary outcomes (5)
[18F]ML10 tumour uptake
To explore the relationship between [18F]ML10 tumour uptake and tissue markers
Measured: 2.5 years
Image optimisation time
To identify an optimal image acquisition time relative to treatment
Measured: 2.5 years
Develop Imaging protocols
To develop simplified imaging protocols for future drug development studies
Measured: 2.5 years
serum markers
To explore the potential role of serum markers in relation to imaging
Measured: 2.5 years
Oncology patients
To evaluate oncology patient compliance and attitudes to imaging studies
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2011 (estimated)
- Study startDec 2009
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: The study was terminated early as the results did not support study objectives and were not as significant as expected.
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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Imperial College London
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428440
- Sponsor's protocol ID
- 113236
- Status last verified
- Jan 2017
- First submitted
- 25 Aug 2011
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Positron Emission Tomography (PET) Study to Evaluate 18FML10 as an Imaging Agent for Tumour Apoptosis
- ClinicalTrials.gov ID
- NCT01428440
- Acronym / sponsor ID
- 113236
- Conditions
- Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early as the results did not support study objectives and were not as significant as expected.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Imperial College London
- Study start
- Dec 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 5 Sep 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.
Apoptosis or programmed cell death is disrupted in cancer cells allowing them to live longer. A number of anti-cancer agents induce apoptosis as a mechanism of drug action to get rid of cancers. A biomarker that would allow apoptosis in tumours to be imaged directly would provide a powerful new tool for oncology drug development and potentially contribute to improved patient care. In this study, we propose to evaluate [18F]ML10-PET for imaging tumour apoptosis in patients receiving standard chemotherapy treatment for their cancer.
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 | Other | Radiation: 18FML10 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients >18 years of age at screening with histological or cytological diagnosis of non-Hodgkin's lymphoma, small cell lung cancer, breast or ovarian cancer who have been worked up clinically (see below) and due to receive standard chemotherapy treatment, but enrolled prior to the initiation of chemotherapy.
- A female subject is eligible to participate if she is of non-childbearing potential or if she is of childbearing potential and agrees to use one of the contraception methods listed. Male subjects are eligible to participate if he also agrees to use one of the contraception methods listed.
- Tumour that is considered by the investigator to be able to be imaged using PET (about 2cm in size or more)
- Able to lie comfortably on back for up to 65 minutes at a time.
- Capable of giving written informed consent, and willing and able to comply with the requirements and restrictions listed in the consent form.
Key exclusion criteria (5 listed)
- Any medical or psychiatric diagnoses or symptoms or social situations that in the view of the investigator would limit compliance with study requirements.
- Pregnant or breast feeding females.
- Received any other anticancer therapy (radiotherapy, chemotherapy, or immunotherapy) or any other investigational agent, including an investigational anti-cancer agent within 28 days prior to the first [18F]ML10-PET scan.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Inability to comply with contraceptive guidelines during the study.
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 |
|---|---|---|
| 18FML10apoptosis imaging radio ligand | Radiation | no treatment |
Primary outcome
Apoptosis imaging
Time frame: 2.5 years
Evaluate feasibility of apoptosis imaging with [18F]ML10 PET/CT in
5 secondary outcomes
[18F]ML10 tumour uptake
Time frame: 2.5 years
Image optimisation time
Time frame: 2.5 years
Develop Imaging protocols
Time frame: 2.5 years
serum markers
Time frame: 2.5 years
Oncology patients
Time frame: 2.5 years
Results and safety
The study was stopped early (reason given: The study was terminated early as the results did not support study objectives and were not as significant as expected.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18FML10 in people with Cancer, run by GlaxoSmithKline at 2 sites 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 7 inclusion and 5 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 12 Jan 2017. 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: The study was terminated early as the results did not support study objectives and were not as significant as expected.). 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?
Apoptosis imaging (time frame: 2.5 years). 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 12 Jan 2017.