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Trial record 1 of 1 for:    C08-315-01
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Dose-escalation Study of LTX-315 in Patients With a Transdermally Accessible Tumour

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ClinicalTrials.gov Identifier: NCT01058616
Recruitment Status : Completed
First Posted : January 28, 2010
Last Update Posted : February 11, 2013
Sponsor:
Collaborators:
Oslo University Hospital
Karolinska University Hospital
Information provided by (Responsible Party):
Lytix Biopharma AS

Study Description
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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.

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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Dose-escalation Study of LTX-315 in Patients With a Transdermally Accessible Tumour
Study Start Date : January 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013
Arms and Interventions
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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.

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01058616


Locations
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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
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Principal Investigator: Paal Brunsvig, MD, PhD Oslo University Hospital, Radiumhosptalet, Oslo, Norway
More Information
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Responsible Party: Lytix Biopharma AS
ClinicalTrials.gov Identifier: NCT01058616    
Other Study ID Numbers: C08-315-01
First Posted: January 28, 2010    Key Record Dates
Last Update Posted: February 11, 2013
Last Verified: February 2013