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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000914-38-ES

Enrollment

200

Registered

2013-04-09

Start date

2013-06-18

Completion date

Unknown

Last updated

2018-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced malignancies MedDRA version: 16.0 Level: LLT Classification code 10007050 Term: Cancer System Organ Class: 100000004864

Interventions

Pharmaceutical Form: Concentrate for solution for infusion Pharmaceutical Form: Solution for injection/infusion Pharmaceutical Form: Concentrate for solution for infusion Pharmaceutical Form: Conce

Eligibility

Sex/Gender

All

Inclusion 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: 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

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 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)

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the individual outcome of patients with advanced malignancies, by comparing the progression-free survival (PFS) using a treatment regimen selected by a molecular analysis of a patient?s tumor with the PFS for the most recent regimen on which the patient had experienced progression - ARM A : PFS2/PFS1 >1.5 in 50% of patients - ARM B : PFS2/PFS1 >1.5 in 40% of patients;Secondary Objective: 1. Accumulation of a specific set of data, enabling to ameliorate the overall performance of the predictive method and enabling fine tuning of the algorithm. 2. Optimize use of biopsies, and increase knowledge in handling biopsies of tumor and normal tissues and optimize histological preparation and extraction of DNA and RNA from strictly the same tumor or normal cells.;Primary end point(s): Progression-free survival (PFS) under study treatment (PFS2). This value will be compared to PFS of the last therapeutic line (PFS1) before entering into study. A clinical meaningful improvement is defined as demonstrating a PFS ratio (PFS2/PFS1) of being 1.5 or better.;Timepoint(s) of evaluation of this end point: Throughout the entire study	—

Measure

Time frame

Main Objective: To assess the individual outcome of patients with advanced malignancies, by comparing the progression-free survival (PFS) using a treatment regimen selected by a molecular analysis of a patient?s tumor with the PFS for the most recent regimen on which the patient had experienced progression - ARM A : PFS2/PFS1 >1.5 in 50% of patients - ARM B : PFS2/PFS1 >1.5 in 40% of patients;Secondary Objective: 1. Accumulation of a specific set of data, enabling to ameliorate the overall performance of the predictive method and enabling fine tuning of the algorithm. 2. Optimize use of biopsies, and increase knowledge in handling biopsies of tumor and normal tissues and optimize histological preparation and extraction of DNA and RNA from strictly the same tumor or normal cells.;Primary end point(s): Progression-free survival (PFS) under study treatment (PFS2). This value will be compared to PFS of the last therapeutic line (PFS1) before entering into study. A clinical meaningful improvement is defined as demonstrating a PFS ratio (PFS2/PFS1) of being 1.5 or better.;Timepoint(s) of evaluation of this end point: Throughout the entire study

—

Secondary

Measure	Time frame
Secondary end point(s): -Number of patients who will benefit from targeted therapy (Arm A) and number of patients who will be eligible and benefit from alternative predictive method (Arm B). -Number of patients who will benefit from combinations vs. mono-therapies.;Timepoint(s) of evaluation of this end point: Throughout the entire study	—

Countries

France, Israel, Spain, United States

Contacts

Public ContactClinical Trials Office

Vall d'Hebron Institute of Oncology (VHIO)

gsala@vhio.net+349327460004922

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026