Dose-escalation Study of LTX-315 in Patients With a Transdermally Accessible Tumour
|Cancer With Transdermal Accessible Tumour||Drug: LTX-315 (Oncopore™)||Phase 1|
|Study Design:||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 ]
- 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 ]
|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|