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WINTHER: A Study to Select Rational Therapeutics Based on the Analysis of Matched Tumor and Normal Biopsies in Subjects With Advanced Malignancies


N/A
18 Years
N/A
Open (Enrolling)
Both
Metastatic Cancer

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Trial Information

WINTHER: A Study to Select Rational Therapeutics Based on the Analysis of Matched Tumor and Normal Biopsies in Subjects With Advanced Malignancies


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 1.1 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 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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

Progression Free Survival

Outcome Description:

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 The primary endpoint of the study is the ratio of the PFS of the current treatment (PFS2) versus the previous treatment (PFS1). Because patients will be enrolled in the study while they are still on treatment (before progression), we expect that PFS for the previous treatment is fully observed. If patients withdrew from the treatment due to treatment related toxicity and lost to follow-up, it is considered that the PFS endpoint is reached. If patients are lost to follow up due to other reasons, PFS is censored at the time of last follow up.

Outcome Time Frame:

Up to 6 months

Safety Issue:

No

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

2012-A01738-35

NCT ID:

NCT01856296

Start Date:

April 2013

Completion Date:

October 2013

Related Keywords:

  • Metastatic Cancer
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

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