Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04116541

A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors.

Led by Centre Leon Berard · Updated on 2026-04-24

455

Participants Needed

10

Research Sites

400 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This trial is a multicenter, open-label, biology driven, phase II study using a sequential Bayesian design, aiming to assess the efficacy and safety of different Matched Targeted Therapy (MTT) in independent and parallel cohorts of treatment. Patients will be assigned to a treatment cohort based on molecular alterations/characteristics detected on tumor sample from primary tumor or metastatic lesion. In this protocol, several MTTs treatment cohorts are planned. This study is designed with the flexibility to open new MTTs treatment cohorts and to close existing MTTs treatment cohorts that demonstrate no clinical benefit. Each treatment cohort will be driven separately even though procedures, quality control and reporting, will be common. The protocol will be amended in order to include new treatments or combinations that emerge as being of interest for patients with advanced/metastatic cancers. All eligible patients will receive study drugs as long as patient experiences clinical benefit in the opinion of the investigator, or until unacceptable toxicity, or until symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status, or withdrawal of consent. Patients will be permitted to continue study treatment after progressive disease according to RECIST v1.1 if they meet all of the following criteria and following validation of the Sponsor: * Evidence of clinical benefit as assessed by the investigators, * Absence of symptoms and signs (including worsening of laboratory values; e.g., new or worsening hypercalcemia) that indicate unequivocal progression of disease, * No decline in ECOG Performance Status (PS) that can be attributed to disease progression.

CONDITIONS

Official Title

A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients aged at least 18 years at consent
  • Histologically confirmed metastatic or unresectable locally advanced malignancy resistant or refractory to standard therapies or without appropriate standard treatments
  • Specific molecular alterations recommended by a multidisciplinary molecular board for targeted therapy
  • Previously treated with at least one prior line of therapy in advanced/metastatic setting except specific tumor types without approved standard treatment
  • Documented radiological disease progression with at least one measurable lesion per RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ and cardiovascular function
  • Prior therapy-related toxicities resolved to grade 1 or less except alopecia, grade 2 neuropathy or anemia
  • Men must use effective contraception unless infertile
  • Women of child-bearing potential must test negative for pregnancy within 7 days before first dose and use effective contraception
  • Ability to understand, sign informed consent, and comply with study procedures
  • Medical insurance coverage
Not Eligible

You will not qualify if you...

  • Patients suitable for curative therapy
  • Participation in another clinical trial with a medicinal product
  • Previous treatment with similar matched targeted therapies affecting the same pathways
  • Inability to swallow oral medication
  • Known hypersensitivity to study drug excipients
  • Symptomatic unstable central nervous system metastases requiring increasing corticosteroids or local CNS therapy
  • Secondary malignancy interfering with study assessments unless approved by sponsor
  • Use or required use of prohibited medications or failure to respect washout periods
  • Clinically significant or uncontrolled medical conditions affecting study participation
  • Psychiatric or substance abuse disorders interfering with trial cooperation
  • Pregnant or breastfeeding women or those planning conception during the study period

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 10 locations

1

Institut Bergonié

Bordeaux, France, 33076

Actively Recruiting

2

Centre François Baclesse

Caen, France, 14076

Actively Recruiting

3

Centre Léon Bérard

Lyon, France, 69373

Actively Recruiting

4

Institut Paoli Calmettes

Marseille, France, 13273

Actively Recruiting

5

Centre Antoine LACASSAGNE

Nice, France, 06189

Actively Recruiting

6

Institut Curie

Paris, France, 75248

Not Yet Recruiting

7

Institut de Cancérologie de Strasbourg

Strasbourg, France, 67033

Terminated

8

CHU Strasbourg - Hôpital de Hautepierre

Strasbourg, France, 67098

Actively Recruiting

9

Institut Claudius Regaud

Toulouse, France, 31059

Actively Recruiting

10

Institut Gustave Roussy

Villejuif, France, 94805

Actively Recruiting

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Research Team

J

Jean-Yves BLAY, MD

CONTACT

O

Olivier TREDAN, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

7

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