Solid TumoursPhase 1/2LON002-002NCT02263950
A Phase 1/2a Study of LON002 in Subjects With Advanced Solid Tumours
A Phase 1/2 study testing Artemether in people with Solid Tumours, run by LondonPharma Ltd. at 2 sites in United Kingdom.
Trial summary
This clinical trial will assess whether a medicine called artemether, currently used at a lower dose to treat malaria, could also be useful in treating cancer. For this trial, the medicine is given in a new way, as a spray under the tongue. 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?
- Artemether
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Oct 2014to Oct 2016
- Phase
- Phase 1/2
- 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
- Subjects of 18 years or older at the Screening Visit.
- Histologic and/or cytologically confirmed diagnosis of solid tumour with clinical and imaging evidence that the tumour is advanced and for whom there is no effective standard therapy available.
- At least one evaluable tumour that is at least 10 mm by computerised tomography (CT) scan or magnetic resonance imaging (MRI) at the pre-treatment stage
- At least one prior systemic anti-cancer treatment and disease that is refractory or progressive following treatment.
- Eastern Co operative Oncology Group (ECOG) performance ≤ 2.
- An adequate renal, liver and bone marrow function.
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- Women of child bearing potential (WOCBP) 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, as detailed in the protocol.
- Male subjects must have had a successful vasectomy (confirmed azoospermia) or they and their female partner must meet the criteria defined in the protocol (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period and for 30 days after study drug discontinuation). Those with partners using hormonal contraceptives must also be using an additional approved method of barrier contraception.
- Expected life expectancy > 4 months.
Who cannot join
- Unwillingness or inability to provide informed consent.
- Any evidence of severe or uncontrolled systemic diseases, infection or laboratory finding that in the view of the Investigator makes it undesirable for the patient to participate in the trial.
- Allergic to artemether or other artemisinin derivatives or any of the components of the sublingual formulation.
- Pregnancy or lactation.
- Subject had major surgery or significant traumatic injury within 4 weeks of start of study drug; subject has not recovered from the side effects of any major surgery (defined as requiring general anaesthesia) or subject might require major surgery during the course of the study.
- Subject has had anti-cancer treatment within 4 weeks of start of study drug, excluding small field palliative irradiation which may be performed up to 2 weeks prior to start of study drug.
- Subject has had prior treatment with any investigational drug within the preceding 4 weeks before study start.
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
Official title: A Phase 1/2a Study of LON002 (Sublingual Artemether Spray) in Subjects With Advanced Solid Tumours.
This clinical trial will assess whether a medicine called artemether, currently used at a lower dose to treat malaria, could also be useful in treating cancer. For this trial, the medicine is given in a new way, as a spray under the tongue. This delivery has several advantages, including better absorption into the body and it may be easier for people to take. It will be prescribed to consenting patients with advanced solid tumours, every day for 4 months, either once or twice a day. (For this study 'advanced tumour' will mean there are no other effective standard therapy options available to the patient).
The dose will be decided in Phase 1 of the study by initially testing 3 different doses of the medicine in up to 21 different cancer patients, to make sure it is not too toxic or causes any side effects.
After this, the highest safe dose identified in the first phase will be tested in up to 66 cancer patients in Phase 2 of the study, to see if the medicine is able to reduce the size of their tumour or slow down its growth.
- Conditions
- Solid Tumours
- Being tested
- Artemether
- Keywords
- Cancer, Malignant Neoplasm, Artemether, Sublingual, Neoplastic disease, Solid Tumour, Anti-cancer drug, Chemotherapy, LON002
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArtemetherDrug
Also called LON002
Artemether sublingual spray at 20mg per spray. Dose escalation study design as per protocol; in Phase 1, three dose levels will be given. The Phase 2 dose will be determined from the results of Phase 1. All patients will receive 4 cycles of dosing, 28 days per cycle.
| Study group | Role | What they receive |
|---|---|---|
| LON002 | Experimental | (Artemether sublingual spray) Receives: Drug: Artemether |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the Recommended Phase 2 Dose (RP2D) to be used in Phase 2a of the study
Measured: 28 days
Number (%) of patients with clinical benefit in Phase 2a
- Complete or partial response at any time based on imaging
- Stable disease at 16 weeks (4 cycles); and/or
- Reduction of validated biomarkers
Measured: 16 weeks
Secondary outcomes (2)
Number of subjects with Dose limiting toxicities
Measured: 16 weeks
Time to progression (TTP), progression free survival (PFS) and overall survival (OS).
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 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
- NCT02263950
- Sponsor's protocol ID
- LON002-002
- Acronym
- LON002-002
- Status last verified
- Sep 2015
- First submitted
- 8 Oct 2014
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a Study of LON002 (Sublingual Artemether Spray) in Subjects With Advanced Solid Tumours.
- ClinicalTrials.gov ID
- NCT02263950
- Acronym / sponsor ID
- LON002-002 / LON002-002
- Conditions
- Solid Tumours
- Keywords
- Cancer, Malignant Neoplasm, Artemether, Sublingual, Neoplastic disease, Solid Tumour, Anti-cancer drug, Chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- LondonPharma Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 15 Oct 2014 (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 clinical trial will assess whether a medicine called artemether, currently used at a lower dose to treat malaria, could also be useful in treating cancer. For this trial, the medicine is given in a new way, as a spray under the tongue. This delivery has several advantages, including better absorption into the body and it may be easier for people to take. It will be prescribed to consenting patients with advanced solid tumours, every day for 4 months, either once or twice a day. (For this study 'advanced tumour' will mean there are no other effective standard therapy options available to the patient).
The dose will be decided in Phase 1 of the study by initially testing 3 different doses of the medicine in up to 21 different cancer patients, to make sure it is not too toxic or causes any side effects.
After this, the highest safe dose identified in the first phase will be tested in up to 66 cancer patients in Phase 2 of the study, to see if the medicine is able to reduce the size of their tumour or slow down its growth.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LON002 | Experimental | Drug: Artemether(Artemether sublingual spray) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects of 18 years or older at the Screening Visit.
- Histologic and/or cytologically confirmed diagnosis of solid tumour with clinical and imaging evidence that the tumour is advanced and for whom there is no effective standard therapy available.
- At least one evaluable tumour that is at least 10 mm by computerised tomography (CT) scan or magnetic resonance imaging (MRI) at the pre-treatment stage
- At least one prior systemic anti-cancer treatment and disease that is refractory or progressive following treatment.
- Eastern Co operative Oncology Group (ECOG) performance ≤ 2.
Key exclusion criteria (7 listed)
- Unwillingness or inability to provide informed consent.
- Any evidence of severe or uncontrolled systemic diseases, infection or laboratory finding that in the view of the Investigator makes it undesirable for the patient to participate in the trial.
- Allergic to artemether or other artemisinin derivatives or any of the components of the sublingual formulation.
- Pregnancy or lactation.
- Subject had major surgery or significant traumatic injury within 4 weeks of start of study drug; subject has not recovered from the side effects of any major surgery (defined as requiring general anaesthesia) or subject might require major surgery during the course of 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 |
|---|---|---|
| ArtemetherAlso: LON002Artemether sublingual spray at 20mg per spray. Dose escalation study design as per protocol; in Phase 1, three dose levels will be given. The Phase 2 dose will be determined from the results of Phase 1. All patients will receive 4 cycles of dosing, 28 days per cycle. | Drug | LON002 |
Primary outcome
Determination of the Recommended Phase 2 Dose (RP2D) to be used in Phase 2a of the study
Time frame: 28 days
Number (%) of patients with clinical benefit in Phase 2a
Time frame: 16 weeks
* Complete or partial response at any time based on imaging * Stable disease at 16 weeks (4 cycles); and/or * Reduction of validated biomarkers
2 secondary outcomes
Number of subjects with Dose limiting toxicities
Time frame: 16 weeks
Time to progression (TTP), progression free survival (PFS) and overall survival (OS).
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
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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.
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 Phase 1/2 study testing Artemether 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 10 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: status not confirmed, as of the sponsor's last update on 7 Sep 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.
What does this combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact London Pharma Ltd (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?
Determination of the Recommended Phase 2 Dose (RP2D) to be used in Phase 2a of the study (time frame: 28 days). The study lists 2 primary outcomes in all. 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 7 Sep 2015.