Phase One Study With Direct Individual Benefit: Effects of OM-174 in Adult Patients With Solid Tumors.
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Solid Tumors
Both
Solid Tumors
Trial Information
Phase One Study With Direct Individual Benefit: Effects of OM-174 in Adult Patients With Solid Tumors.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Masking: Open Label
Outcome Measure:
The occurrence of any adverse event
Outcome Time Frame:
up to 8 weeks
Safety Issue:
Yes
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
BARDOU PHRC R 2002
NCT ID:
NCT01800812
Start Date:
March 2007
Completion Date:
Related Keywords:
- Solid Tumors
- Neoplasms
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