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

This study has been completed.
Sponsor:
Collaborators:
Oslo University Hospital
Karolinska University Hospital
Information provided by (Responsible Party):
Lytix Biopharma AS
ClinicalTrials.gov Identifier:
NCT01058616
First received: January 27, 2010
Last updated: February 8, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Cancer With Transdermal Accessible Tumour
Drug: LTX-315 (Oncopore™)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Dose-escalation Study of LTX-315 in Patients With a Transdermally Accessible Tumour

Resource links provided by NLM:


Further study details as provided by Lytix Biopharma AS:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of the anti-tumour activity: Objective response in the target tumour, response in non-target tumours, Immunological response. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Core biopsy staining for lymphocyte infiltratio [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Tumour volume measurment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: January 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058616

Locations
Norway
Oslo University Hospital, Radiumhospitalet
Oslo, Norway, 0310
Sweden
Karolinska University Hospital, Solna
Stockholm, Sweden, 171 76
Sponsors and Collaborators
Lytix Biopharma AS
Oslo University Hospital
Karolinska University Hospital
Investigators
Principal Investigator: Paal Brunsvig, MD, PhD Oslo University Hospital, Radiumhosptalet, Oslo, Norway
  More Information

No publications provided

Responsible Party: Lytix Biopharma AS
ClinicalTrials.gov Identifier: NCT01058616     History of Changes
Other Study ID Numbers: C08-315-01
Study First Received: January 27, 2010
Last Updated: February 8, 2013
Health Authority: Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency

ClinicalTrials.gov processed this record on October 29, 2014