Solid TumoursNCT02390986
An Extension Study of LON002 in Patients With Cancer
A study testing LON002 in people with Solid Tumours, run by LondonPharma Ltd. at 2 sites in United Kingdom.
Trial summary
The purpose of this clinical trial is to evaluate the long term safety and efficacy of LON002. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumours
- What is being tested?
- LON002
- How many people
- 50 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2015to Jun 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
- Written informed consent;
- Has completed a LondonPharma sponsored parent trial of LON002 and continues to have clinical benefit in the judgement of the investigator;
- Eligible for continuation of LON002 treatment at the end of the parent trial, according to the parent trial protocol;
- Able to comply with the protocol LON002-003;
- Women of child bearing potential must have a negative pregnancy test before the start of treatment;
- Sexually active women of childbearing potential must be using an acceptable form of contraception for the duration of dosing and for 30 days thereafter;
- Male subjects with female partners of childbearing potential should use condoms for the duration of dosing and for 30 days thereafter
Who cannot join
- Has not completed a LondonPharma sponsored parent trial of LON002;
- Unequivocal evidence of disease progression;
- Unacceptable toxicity experienced in the parent trial;
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
The Royal Surrey County Hospital
Guildford, Surrey, GU2 7XX
Mazhar Ajaz, MD
- Recruiting
Guy's and St Thomas NHS Foundation Trust
London, SE1 9RT
Debashis Sarker, MD
About this study
The purpose of this clinical trial is to evaluate the long term safety and efficacy of LON002.
Read the detailed description
This is an extension study of LON002 in patients with cancer, who have completed other London Pharma sponsored LON002 studies (parent study). It provides the opportunity for patients to continue receiving treatment for as long as the patient continues to derive a clinical benefit.
Long term safety and efficacy will be evaluated.
- Conditions
- Solid Tumours
- Being tested
- LON002
- Keywords
- Cancer, Malignant Neoplasm, Anti-cancer drug
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LON002Drug
Extension study to provide continuing access to LON002 medication.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with Adverse Events grade ≥3 related to LON002 and Serious Adverse Events related to LON002 as a measure of safety and tolerability.
Measured: Participants will be followed for the duration of their study treatment, an expected average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumoursStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LondonPharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Debashis Sarker, MD, Principal investigator, Guy's and St Thomas' NHS Foundation TrustMazhar Ajaz, MD, Principal investigator, Royal Surrey County Hospital NHS TrustDaryl Bendel, MD, Study director, Xidea Solutions Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390986
- Sponsor's protocol ID
- LON002-003
- Status last verified
- Mar 2015
- First submitted
- 2 Mar 2015
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Study of LON002 in Patients With Cancer
- ClinicalTrials.gov ID
- NCT02390986
- Acronym / sponsor ID
- LON002-003
- Conditions
- Solid Tumours
- Keywords
- Cancer, Malignant Neoplasm, Anti-cancer drug
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- LondonPharma Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 18 Mar 2015 (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 clinical trial is to evaluate the long term safety and efficacy of LON002.
Detailed description
This is an extension study of LON002 in patients with cancer, who have completed other London Pharma sponsored LON002 studies (parent study). It provides the opportunity for patients to continue receiving treatment for as long as the patient continues to derive a clinical benefit.
Long term safety and efficacy will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent;
- Has completed a LondonPharma sponsored parent trial of LON002 and continues to have clinical benefit in the judgement of the investigator;
- Eligible for continuation of LON002 treatment at the end of the parent trial, according to the parent trial protocol;
- Able to comply with the protocol LON002-003;
- Women of child bearing potential must have a negative pregnancy test before the start of treatment;
Key exclusion criteria (3 listed)
- Has not completed a LondonPharma sponsored parent trial of LON002;
- Unequivocal evidence of disease progression;
- Unacceptable toxicity experienced in the parent trial;
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 |
|---|---|---|
| LON002Extension study to provide continuing access to LON002 medication. | Drug | – |
Primary outcome
Proportion of patients with Adverse Events grade ≥3 related to LON002 and Serious Adverse Events related to LON002 as a measure of safety and tolerability.
Time frame: Participants will be followed for the duration of their study treatment, an expected average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
Related trials for Solid Tumours
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
Debashis Sarker, MD principal investigator
Guy's and St Thomas' NHS Foundation Trust
Mazhar Ajaz, MD principal investigator
Royal Surrey County Hospital NHS Trust
Daryl Bendel, MD study director
Xidea Solutions Ltd
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LON002 in people with Solid Tumours, run by LondonPharma Ltd. 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 3 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: status not confirmed, as of the sponsor's last update on 18 Mar 2015. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Laskow-Pooley (01865 784485, davidlaskow-pooley@londonpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with Adverse Events grade ≥3 related to LON002 and Serious Adverse Events related to LON002 as a measure of safety and tolerability. (time frame: Participants will be followed for the duration of their study treatment, an expected average of 6 months). 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 18 Mar 2015.