Dose-escalation Study of LTX-315 in Patients With a Transdermally Accessible Tumour

Cancer With Transdermal Accessible Tumour Clinical Trial

Official title:

Phase 1 Dose-escalation Study of LTX-315 in Patients With a Transdermally Accessible Tumour

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01058616
• Other study ID #: C08-315-01
• Status: Completed
• Phase: Phase 1
• First received: January 27, 2010
• Last updated: February 8, 2013
• Start date: January 2010
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: Lytix Biopharma AS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencySweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer With Transdermal Accessible Tumour

Intervention

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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital, Radiumhospitalet	Oslo
Sweden	Karolinska University Hospital, Solna	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Lytix Biopharma AS	Karolinska University Hospital, Oslo University Hospital

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		12 weeks	No
Secondary	Assessment of the anti-tumour activity: Objective response in the target tumour, response in non-target tumours, Immunological response.		12 weeks	No
Secondary	Core biopsy staining for lymphocyte infiltratio		12 weeks	No
Secondary	Tumour volume measurment		12 weeks	No