Clinical trial NCT01058616: Dose-escalation Study of LTX-315 in Patients With a Transdermally Accessible Tumour
Official title: Phase 1 Dose-escalation Study of LTX-315 in Patients With a Transdermally Accessible Tumour
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer With Transdermal Accessible Tumour
Lead sponsor: Lytix Biopharma AS
Sponsor class: INDUSTRY
Collaborators: name: Oslo University Hospital
name: Karolinska University Hospital
First posted: 2010-01-28
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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:

1. Histologically confirmed malignant tumour
2. Transdermally accessible lesion (in or close to the skin)
3. Age ≥ 18 years
4. ECOG Performance status (PS): 0 - 2
5. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
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.
timeFrame: 12 weeks
Secondary outcomes:
measure: Assessment of the anti-tumour activity: Objective response in the target tumour, response in non-target tumours, Immunological response.
timeFrame: 12 weeks
measure: Core biopsy staining for lymphocyte infiltratio
timeFrame: 12 weeks
measure: Tumour volume measurment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Radiumhospitalet
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Solna
Study officials:
affiliation: Oslo University Hospital, Radiumhosptalet, Oslo, Norway
name: Paal Brunsvig, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: