A study to select the better treatment based on the analysis of matched tumor and normal biopsies in subjects with advanced malignancies

Phase 1

• Conditions: Advanced malignancies; MedDRA version: 16.0Level: LLTClassification code 10007050Term: CancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-000914-38-ES
• Lead Sponsor: Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-09
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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
Symptomatic or progressive brain metastases detected by radio imaging, or meningeal
Patient who received a personalized therapeutic treatment based on molecular anomaly during the last treatment (defining the PFS1)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified