CarcinomaPhase 1NCT01223209
A Study, Combination, Immunologic Study of LTX-315 as Adjunct to GV1001 in Patients Following Curative Surgery for Carcinoma
A Phase 1 study testing LTX-315 in people with Carcinoma, run by Lytix Biopharma AS at 1 site in Norway.
Trial summary
This study involves testing of the medicine LTX-315 combined with a cancer vaccine (GV1001). This will be tested in patients that have had surgery with curative intent for malignant tumour. GV1001 is a peptide vaccine in development to treat cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma
- What is being tested?
- LTX-315
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2010to Jan 2012
- 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
- Curative surgery for carcinoma performed at least three months prior to treatment start
- Age ≥18 years
- ECOG Performance status (PS): 0
- Life expectancy: at least 3 months
- Laboratory requirements:
- White Blood Count (WBC) ≥ 3 x 109/L
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- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- Haemoglobin ≥ 10.0 g/dL
- Total bilirubin level ≤ 1.5 ULN
- AST and ALT ≤ 2.5 x ULN
- Creatinine ≥ 1.5 ULN
- Albumin > 30 g/L
- No expectation of anti-cancer therapy or immunotherapy during the trial period, hormone therapy given as adjunctive or contraceptive therapy is permitted
- Must be willing to practice acceptable barrier methods of birth control to prevent pregnancy
- The patient is willing and able to comply with the protocol and agrees to return to the hospital for follow-up visits and examination
- The patient has been fully informed about the study and has signed the informed consent form
Who cannot join
- Has received an investigational drug within 4 weeks prior to study drug administration, or is scheduled to receive one during the treatment or the post-treatment period
- Has received immunotherapy or been vaccinated within 12 weeks prior to study drug administration or has not recovered from adverse events due to such agents
- Has received external radiotherapy or cytotoxic chemotherapy within the last 4 weeks prior to study drug administration, or has not recovered from adverse events (< Grade 1) due to agents administered more than 4 weeks earlier
- Has received imiquimod within 12 weeks prior to study drug administration or has not recovered from associated adverse events
- Is currently on any agent with a known effect on the immune system
- Has any other serious illness or medical condition such as but not limited to:
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- Any uncontrolled infection or infection requiring antibiotics
- Uncontrolled cardiac failure Classification III or IV (New York Heart Association)
- Uncontrolled systemic and gastro-intestinal inflammatory conditions
- Bone marrow dysplasia
- History of auto-immune disease
- History of adverse reaction to vaccines
- Known history of positive tests for HIV/AIDS, hepatitis B or C
- Is pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Combination, Immunologic Study of LTX-315 as Adjunct to GV1001 in Patients Following Curative Surgery for Carcinoma
This study involves testing of the medicine LTX-315 combined with a cancer vaccine (GV1001). This will be tested in patients that have had surgery with curative intent for malignant tumour.
GV1001 is a peptide vaccine in development to treat cancer. An adjuvant, is required to start the immune response in the body to have effect of GV-1001.
LTX-315, also a peptide, in development for cancer treatment. In this study, the investigators wish to find out whether LTX-315 can make GV1001 more effective at stimulating the immune system.
Read the detailed description
This clinical study has two main aims which are:
- To measure the immunological effects of LTX-315 in combination with GV1001
- Find out about the side effects of the combination of the two drugs This is an open label, single centre study assessing immunological effects and safety of LTX-315 given as an adjunct to GV1001. The LTX-315 dose will escalate while the GV1001 dose will be fixed.
LTX-315 and GV1001 will be given as intradermal injections on days 1, 8, 15, 22 and 36.
Investigational treatment: LTX-315 (0.10 mL) with escalating concentrations will be injected intradermally, followed, 1-2 hours later, by intradermal injection of 0.56 mg GV1001 (0.20 mL, 2.8 mg/mL) in the same site, in one arm.
DTH-test control: 0.10 mg GV1001 (0.10 mL) will be injected intradermally in the contralateral arm without LTX-315, as a DTH skin reactivity test control.
- Conditions
- Carcinoma
- Being tested
- LTX-315
- Keywords
- Cancer, Carcinoma, Curative surgery, Curative surgery for carcinoma at least three months and not more than 5 years prior to treatment start
- Medical subject headings
- Carcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTX-315Drug
Also called GV-1001
0.25-2.0 mg/ML, maximum 5 injections during 36 days.
| Study group | Role | What they receive |
|---|---|---|
| LTX-315 | Experimental | The dose range of 0,25-2.0 mg/ML LTX-315 will be used. In combination with a fixed dose of GV-1001. Receives: Drug: LTX-315 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunological effects of LTX-315 in combination with GV1001 as measured by DTH skin test reaction and T-cell function in peripheral blood.
Patients will return to the site 24 to 48 hours after the LTX-315 and GV1001 injections for DTH assessment and in week 10 for an end of study assessment.
Measured: 5 injections, treatment period 36 days
Secondary outcomes (1)
To evaluate the safety profile of LTX-315 in combination with GV1001 study
Assessment of adverse events and abnormal laboratory values recorded during the
Measured: 5 injections, treatment period 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lytix Biopharma AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kael-GemVax Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Tone Nordøy, MD, PhD, Principal investigator, Tromsø University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223209
- Sponsor's protocol ID
- C09-315-02
- Status last verified
- Jan 2012
- First submitted
- 14 Oct 2010
- Last updated
- 11 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Combination, Immunologic Study of LTX-315 as Adjunct to GV1001 in Patients Following Curative Surgery for Carcinoma
- ClinicalTrials.gov ID
- NCT01223209
- Acronym / sponsor ID
- C09-315-02
- Conditions
- Carcinoma
- Keywords
- Cancer, Carcinoma, Curative surgery, Curative surgery for carcinoma at least three months and not more than 5 years prior to treatment start
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Lytix Biopharma ASIndustry (pharma, biotech, devices)
- Collaborators
- Kael-GemVax Co., Ltd.
- Study start
- Aug 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 18 Oct 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.
This study involves testing of the medicine LTX-315 combined with a cancer vaccine (GV1001). This will be tested in patients that have had surgery with curative intent for malignant tumour.
GV1001 is a peptide vaccine in development to treat cancer. An adjuvant, is required to start the immune response in the body to have effect of GV-1001.
LTX-315, also a peptide, in development for cancer treatment. In this study, the investigators wish to find out whether LTX-315 can make GV1001 more effective at stimulating the immune system.
Detailed description
This clinical study has two main aims which are:
- To measure the immunological effects of LTX-315 in combination with GV1001
- Find out about the side effects of the combination of the two drugs This is an open label, single centre study assessing immunological effects and safety of LTX-315 given as an adjunct to GV1001. The LTX-315 dose will escalate while the GV1001 dose will be fixed.
LTX-315 and GV1001 will be given as intradermal injections on days 1, 8, 15, 22 and 36.
Investigational treatment: LTX-315 (0.10 mL) with escalating concentrations will be injected intradermally, followed, 1-2 hours later, by intradermal injection of 0.56 mg GV1001 (0.20 mL, 2.8 mg/mL) in the same site, in one arm.
DTH-test control: 0.10 mg GV1001 (0.10 mL) will be injected intradermally in the contralateral arm without LTX-315, as a DTH skin reactivity test control.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LTX-315 | Experimental | Drug: LTX-315The dose range of 0,25-2.0 mg/ML LTX-315 will be used. In combination with a fixed dose of GV-1001. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Curative surgery for carcinoma performed at least three months prior to treatment start
- Age ≥18 years
- ECOG Performance status (PS): 0
- Life expectancy: at least 3 months
- Laboratory requirements:
Key exclusion criteria (14 listed)
- Has received an investigational drug within 4 weeks prior to study drug administration, or is scheduled to receive one during the treatment or the post-treatment period
- Has received immunotherapy or been vaccinated within 12 weeks prior to study drug administration or has not recovered from adverse events due to such agents
- Has received external radiotherapy or cytotoxic chemotherapy within the last 4 weeks prior to study drug administration, or has not recovered from adverse events (< Grade 1) due to agents administered more than 4 weeks earlier
- Has received imiquimod within 12 weeks prior to study drug administration or has not recovered from associated adverse events
- Is currently on any agent with a known effect on the immune system
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-315Also: GV-10010.25-2.0 mg/ML, maximum 5 injections during 36 days. | Drug | LTX-315 |
Primary outcome
Immunological effects of LTX-315 in combination with GV1001 as measured by DTH skin test reaction and T-cell function in peripheral blood.
Time frame: 5 injections, treatment period 36 days
Patients will return to the site 24 to 48 hours after the LTX-315 and GV1001 injections for DTH assessment and in week 10 for an end of study assessment.
1 secondary outcome
To evaluate the safety profile of LTX-315 in combination with GV1001 study
Time frame: 5 injections, treatment period 36 days
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 Jan 2012.
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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.
Tone Nordøy, MD, PhD principal investigator
Tromsø University Hospital
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 LTX-315 in people with Carcinoma, run by Lytix Biopharma AS at 1 site in Norway.
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 17 inclusion and 14 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 Jan 2012. 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 Norway. 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?
Immunological effects of LTX-315 in combination with GV1001 as measured by DTH skin test reaction and T-cell function in peripheral blood. (time frame: 5 injections, treatment period 36 days). 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 Jan 2012.