Cancer With Transdermal Accessible TumourPhase 1NCT01058616
Dose-escalation Study of LTX-315 in Patients With a Transdermally Accessible Tumour
A Phase 1 study testing LTX-315 (Oncopore™) in people with Cancer With Transdermal Accessible Tumour, run by Lytix Biopharma AS at 2 sites in 2 countries.
Trial summary
The study will evaluate the safety profile for LTX-315 a lytic-peptide that has shown effect in animal models to kill cancer tumours when injected directly in to the tumour. The study will also monitor the immunological response in the body after injection of LTX-315. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer With Transdermal Accessible Tumour
- What is being tested?
- LTX-315 (Oncopore™)
- Type of treatment
- Injection or infusion
- How many people
- 14 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2010to Jan 2013
- 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
- Histologically confirmed malignant tumour. Transdermally accessible lesion (in or close to the skin) of 1 - 5 cm in diameter.
- ECOG Performance status (PS): 0 - 2
- Life expectancy: At least 3 months
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Phase 1 Dose-escalation Study of LTX-315 in Patients With a Transdermally Accessible Tumour
The study will evaluate the safety profile for LTX-315 a lytic-peptide that has shown effect in animal models to kill cancer tumours when injected directly in to the tumour. The study will also monitor the immunological response in the body after injection of LTX-315.
Read the detailed description
A phase I study with an initial concentration/volume escalating part followed by an expanded cohort at the recommended dose (RD). This is an open label, multicentre study assessing the safety, tolerance, PK and efficacy of LTX-315 injected directly into transdermally accessible tumours on days 1 and 8.
Additional weekly injections may be made, for up to a total of 6 injections.
Subjects may be included in the study if they meet all of the following criteria:
- Histologically confirmed malignant tumour
- Transdermally accessible lesion (in or close to the skin)
- Age ≥ 18 years
- ECOG Performance status (PS): 0 - 2
- Life expectancy: At least 3 months
The primary objectives of the study are to evaluate the safety profile of LTX-315 by assessment of adverse events and abnormal laboratory values recorded during the study and to determine the recommended dose of LTX-315.
The secondary objectives of the study are to preliminarily assess the anti-tumour activity of LTX-315 in patients with transdermally accessible tumours, monitor immunological response, pharmacokinetic assessment, and determine duration of response.
- Being tested
- LTX-315 (Oncopore™)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTX-315 (Oncopore™)Drug
5 mg/ml-70 mg/ml. Dosing will be done as transdermal injection of a calculated volume at day 1 and 8. Additionally weekly injections up to a maximum of 4 injections.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate safety profile of LTX-315 by assessment of adverse events and abnormal laboratory values recorded during the study. Necrosis of the target tumour based on imaging and core biopsy analysis.
Measured: 12 weeks
Secondary outcomes (3)
Assessment of the anti-tumour activity: Objective response in the target tumour, response in non-target tumours, Immunological response.
Measured: 12 weeks
Core biopsy staining for lymphocyte infiltratio
Measured: 12 weeks
Tumour volume measurment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer With Transdermal Accessible TumourStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lytix Biopharma AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oslo University Hospital, Karolinska University Hospital
- Responsible party
- Sponsor
- Investigators
- Paal Brunsvig, MD, PhD, Principal investigator, Oslo University Hospital, Radiumhosptalet, Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058616
- Sponsor's protocol ID
- C08-315-01
- Status last verified
- Feb 2013
- First submitted
- 27 Jan 2010
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Dose-escalation Study of LTX-315 in Patients With a Transdermally Accessible Tumour
- ClinicalTrials.gov ID
- NCT01058616
- Acronym / sponsor ID
- C08-315-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Lytix Biopharma ASIndustry (pharma, biotech, devices)
- Collaborators
- Oslo University Hospital, Karolinska University Hospital
- Study start
- Jan 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 28 Jan 2010 (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 study will evaluate the safety profile for LTX-315 a lytic-peptide that has shown effect in animal models to kill cancer tumours when injected directly in to the tumour. The study will also monitor the immunological response in the body after injection of LTX-315.
Detailed description
A phase I study with an initial concentration/volume escalating part followed by an expanded cohort at the recommended dose (RD). This is an open label, multicentre study assessing the safety, tolerance, PK and efficacy of LTX-315 injected directly into transdermally accessible tumours on days 1 and 8.
Additional weekly injections may be made, for up to a total of 6 injections.
Subjects may be included in the study if they meet all of the following criteria:
- Histologically confirmed malignant tumour
- Transdermally accessible lesion (in or close to the skin)
- Age ≥ 18 years
- ECOG Performance status (PS): 0 - 2
- Life expectancy: At least 3 months
The primary objectives of the study are to evaluate the safety profile of LTX-315 by assessment of adverse events and abnormal laboratory values recorded during the study and to determine the recommended dose of LTX-315.
The secondary objectives of the study are to preliminarily assess the anti-tumour activity of LTX-315 in patients with transdermally accessible tumours, monitor immunological response, pharmacokinetic assessment, and determine duration of response.
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 (3 listed)
- Histologically confirmed malignant tumour. Transdermally accessible lesion (in or close to the skin) of 1 - 5 cm in diameter.
- ECOG Performance status (PS): 0 - 2
- Life expectancy: At least 3 months
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| LTX-315 (Oncopore™)5 mg/ml-70 mg/ml. Dosing will be done as transdermal injection of a calculated volume at day 1 and 8. Additionally weekly injections up to a maximum of 4 injections. | Drug | – |
Primary outcome
Evaluate safety profile of LTX-315 by assessment of adverse events and abnormal laboratory values recorded during the study. Necrosis of the target tumour based on imaging and core biopsy analysis.
Time frame: 12 weeks
3 secondary outcomes
Assessment of the anti-tumour activity: Objective response in the target tumour, response in non-target tumours, Immunological response.
Time frame: 12 weeks
Core biopsy staining for lymphocyte infiltratio
Time frame: 12 weeks
Tumour volume measurment
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2013.
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.
Paal Brunsvig, MD, PhD principal investigator
Oslo University Hospital, Radiumhosptalet, Oslo, Norway
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LTX-315 (Oncopore™) in people with Cancer With Transdermal Accessible Tumour, run by Lytix Biopharma AS at 2 sites in 2 countries.
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 3 inclusion and 0 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: finished, as of the sponsor's last update on 11 Feb 2013. 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 Norway, Sweden. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate safety profile of LTX-315 by assessment of adverse events and abnormal laboratory values recorded during the study. Necrosis of the target tumour based on imaging and core biopsy analysis. (time frame: 12 weeks). 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 11 Feb 2013.