Dose-escalation Study of LTX-315 in Patients With a Transdermally Accessible Tumour
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|ClinicalTrials.gov Identifier: NCT01058616|
Recruitment Status : Completed
First Posted : January 28, 2010
Last Update Posted : February 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cancer With Transdermal Accessible Tumour||Drug: LTX-315 (Oncopore™)||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Dose-escalation Study of LTX-315 in Patients With a Transdermally Accessible Tumour|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
- Drug: 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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|