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Trial · Interventional

CompletedPhase 1Registry data

A Study, Combination, Immunologic Study of LTX-315 as Adjunct to GV1001 in Patients Following Curative Surgery for Carcinoma

Overview

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

Norway

Start
Aug 2010
Primary completion
Dec 2011
Completion
Jan 2012
First posted
18 Oct 2010 (estimated)
Last update posted
11 Jan 2012 (estimated)
Conditions
Carcinoma

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201120122013
  1. Ph 1

    A Study, Combination, Immunologic Study of LTX-315 as Adjunct to GV1001 in Patients Following Curative Surgery for Carcinoma

    NCT01223209

    Aug 2010 to Jan 2012

Registry summary

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

This study involves testing of the medicine LTX-315 combined with a cancer vaccine (GV1001). This will be tested in patients that have had surgery with curative intent for malignant tumour. GV1001 is a peptide vaccine in development to treat cancer. An adjuvant, is required to start the immune response in the body to have effect of GV-1001. LTX-315, also a peptide, in development for cancer treatment. In this study, the investigators wish to find out whether LTX-315 can make GV1001 more effective at stimulating the immune system.

Interventions

  • LTX-315Drug

Arms1

  • Experimental

    LTX-315

    The dose range of 0,25-2.0 mg/ML LTX-315 will be used. In combination with a fixed dose of GV-1001.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Immunological effects of LTX-315 in combination with GV1001 as measured by DTH skin test reaction and T-cell function in peripheral blood.

    Time frame · 5 injections, treatment period 36 days

    Registry description

    Patients will return to the site 24 to 48 hours after the LTX-315 and GV1001 injections for DTH assessment and in week 10 for an end of study assessment.

Secondary outcomes(1)
  1. To evaluate the safety profile of LTX-315 in combination with GV1001 study

    Time frame · 5 injections, treatment period 36 days

    Registry description

    Assessment of adverse events and abnormal laboratory values recorded during the

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: * Curative surgery for carcinoma performed at least three months prior to treatment start * Age ≥18 years * ECOG Performance status (PS): 0 * Life expectancy: at least 3 months * Laboratory requirements: * White Blood Count (WBC) ≥ 3 x 109/L * Absolute neutrophil count (ANC) ≥ 1.5 x 109/L * Platelet count ≥ 100 x 109/L * Haemoglobin ≥ 10.0 g/dL * Total bilirubin level ≤ 1.5 ULN * AST and ALT ≤ 2.5 x ULN * Creatinine ≥ 1.5 ULN * Albumin \> 30 g/L * No expectation of anti-cancer therapy or immunotherapy during the trial period, hormone therapy given as adjunctive or contraceptive therapy is permitted * Must be willing to practice acceptable barrier methods of birth control to prevent pregnancy * The patient is willing and able to comply with the protocol and agrees to return to the hospital for follow-up visits and examination * The patient has been fully informed about the study and has signed the informed consent form Exclusion Criteria: * Has received an investigational drug within 4 weeks prior to study drug administration, or is scheduled to receive one during the treatment or the post-treatment period * Has received immunotherapy or been vaccinated within 12 weeks prior to study drug administration or has not recovered from adverse events due to such agents * Has received external radiotherapy or cytotoxic chemotherapy within the last 4 weeks prior to study drug administration, or has not recovered from adverse events (\< Grade 1) due to agents administered more than 4 weeks earlier * Has received imiquimod within 12 weeks prior to study drug administration or has not recovered from associated adverse events * Is currently on any agent with a known effect on the immune system * Has any other serious illness or medical condition such as but not limited to: * Any uncontrolled infection or infection requiring antibiotics * Uncontrolled cardiac failure Classification III or IV (New York Heart Association) * Uncontrolled systemic and gastro-intestinal inflammatory conditions * Bone marrow dysplasia * History of auto-immune disease * History of adverse reaction to vaccines * Known history of positive tests for HIV/AIDS, hepatitis B or C * Is pregnant or breastfeeding

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