NCT01800812

Brief Summary

Methods Patients received OM-174 twice weekly for a total of 5, 10 or 15 injections of either 600, 800 or 1000 µg/m². Pharmacokinetic analysis and cytokine dosages were performed. Natural Killer cells activity and toll-like receptors 4 polymorphism analysis were also performed.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 28, 2013

Completed
Last Updated

February 28, 2013

Status Verified

February 1, 2013

Enrollment Period

10 months

First QC Date

February 22, 2013

Last Update Submit

February 26, 2013

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

  • The occurrence of any adverse event

    up to 8 weeks

Interventions

Injections of OM-174BIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with a histologically proven solid tumor, refractory to conventional treatment or for which no such treatment existed.
  • At least one month since the last chemotherapy
  • Life expectancy above 3 months
  • Written informed consent
  • Age above 18

You may not qualify if:

  • Patient's refusal
  • Infection
  • Brain metastasis
  • Autoimmune disease
  • Regular use of steroids
  • Patient included in another protocol
  • Chemotherapy or radiotherapy less than 6 weeks ago
  • Immunotherapy less than 8 weeks ago

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Isambert N, Fumoleau P, Paul C, Ferrand C, Zanetta S, Bauer J, Ragot K, Lizard G, Jeannin JF, Bardou M. Phase I study of OM-174, a lipid A analogue, with assessment of immunological response, in patients with refractory solid tumors. BMC Cancer. 2013 Apr 2;13:172. doi: 10.1186/1471-2407-13-172.

    PMID: 23547558DERIVED

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2013

First Posted

February 28, 2013

Study Start

March 1, 2007

Primary Completion

January 1, 2008

Last Updated

February 28, 2013

Record last verified: 2013-02