Effects of OM-174 in Adult Patients With Solid Tumors

Phase 1

Completed

• Conditions: Solid Tumors

• Registration Number: NCT01800812
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2008-01
• Status Verified: 2013-02
• Study First Submitted: 2013-02-22
• Study First Submitted QC: 2013-02-26
• Last Update Submitted: 2013-02-26
• Study First Posted: 2013-02-28
• Last Update Posted: 2013-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The occurrence of any adverse event	up to 8 weeks