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

NCT01058616 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2013-02-11

No results posted yet for this study

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.

Conditions

  • Cancer With Transdermal Accessible Tumour

Interventions

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.

Sponsors & Collaborators

  • Oslo University Hospital

    collaborator OTHER

  • Karolinska University Hospital

    collaborator OTHER

  • Lytix Biopharma AS

    lead INDUSTRY

Principal Investigators

  • Paal Brunsvig, MD, PhD · Oslo University Hospital, Radiumhosptalet, Oslo, Norway

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Norway
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01058616 on ClinicalTrials.gov