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Clinical Trials/EUCTR2013-000914-38-ES
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.

Registry
who.int
Start Date
April 9, 2013
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)

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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