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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT01058616 (opens ClinicalTrials.gov in a new tab)Other idC08-315-01
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
14 participants (actual)
Sponsor
Lytix Biopharma AS · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
2 countries

Norway, Sweden

Start
Jan 2010
Primary completion
Jan 2013
Completion
Jan 2013
First posted
28 Jan 2010 (estimated)
Last update posted
11 Feb 2013 (estimated)
Conditions
Cancer With Transdermal Accessible Tumour

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20102011201220132014
  1. Ph 1

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

    NCT01058616

    Jan 2010 to Jan 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LTX-315 (Oncopore™)Drug

Arms0

The registry lists no arms for this trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

  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.

    Time frame · 12 weeks

Secondary outcomes(3)

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

    Time frame · 12 weeks

  2. Core biopsy staining for lymphocyte infiltratio

    Time frame · 12 weeks

  3. Tumour volume measurment

    Time frame · 12 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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