NCT01058616

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2010

Typical duration for phase_1

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 11, 2013

Status Verified

February 1, 2013

Enrollment Period

3 years

First QC Date

January 27, 2010

Last Update Submit

February 8, 2013

Conditions

Cancer With Transdermal Accessible Tumour

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Assessment of the anti-tumour activity: Objective response in the target tumour, response in non-target tumours, Immunological response.

    12 weeks

  • Core biopsy staining for lymphocyte infiltratio

    12 weeks

  • Tumour volume measurment

    12 weeks

Interventions

LTX-315 (Oncopore™)DRUG

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oslo University Hospital, Radiumhospitalet

Oslo, 0310, Norway

Location

Karolinska University Hospital, Solna

Stockholm, 171 76, Sweden

Location

MeSH Terms

Interventions

LTX-315

Study Officials

  • Paal Brunsvig, MD, PhD

    Oslo University Hospital, Radiumhosptalet, Oslo, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2010

First Posted

January 28, 2010

Study Start

January 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 11, 2013

Record last verified: 2013-02

Locations

NO(1)SE(1)