EUCTR2013-000914-38-ES
Active, Not Recruiting
Phase 1
A study to select rational therapeutics based on the analysis of matched tumor and normal biopsies in subjects with advanced malignancies
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)0 sites200 target enrollmentApril 9, 2013
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Advanced malignancies
- Sponsor
- Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
- Enrollment
- 200
- Status
- Active, Not Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Informed consent
- •\- Any histologic type of metastatic cancer, in which histologic normal counterpart can be obtained.
- •\- At least one prior regimen for advanced disease
- •\- Ability to undergo a biopsy or surgical procedure to obtain fresh tumor biopsy paired with its normal counterpart
- •\- Age from 18 years
- •\- Life expectancy of at least 3 months
- •\- Performance status of 0 to 1
- •\- Measurable or evaluable disease according to RECIST
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •Alteration of organ function or hematopoietic function as defined by the following criteria:
- •\- Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) \>2\.5 x upper limit of normal (ULN)
- •\- Bilirubin \> 1\.5 x ULN
- •\- Polynuclear neutrophil \< 1\.5 x 109/L
- •\- Platelets \< 100 x 10 9/L
- •\- Hemoglobin \< 90 g/L
- •\- Creatinine \> 1\.5 ULN
- •\- Calcemia \> ULN
- •\- Phosphatemia \> ULN
- •Coagulation abnormality prohibiting a biopsy
Outcomes
Primary Outcomes
Not specified
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