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.
Cancer With Transdermal Accessible Tumour
Drug: LTX-315 (Oncopore™)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 1 Dose-escalation Study of LTX-315 in Patients With a Transdermally Accessible Tumour|
- 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 ] [ Designated as safety issue: No ]
- Assessment of the anti-tumour activity: Objective response in the target tumour, response in non-target tumours, Immunological response. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Core biopsy staining for lymphocyte infiltratio [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Tumour volume measurment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Drug: LTX-315 (Oncopore™)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01058616
|Oslo University Hospital, Radiumhospitalet|
|Oslo, Norway, 0310|
|Karolinska University Hospital, Solna|
|Stockholm, Sweden, 171 76|
|Principal Investigator:||Paal Brunsvig, MD, PhD||Oslo University Hospital, Radiumhosptalet, Oslo, Norway|