Early clinical trials (phase I)

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Pr Christophe Massard


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Early clinical trials (phase I)

New drugs for new treatments

An early clinical trial (or phase I trial) aims to assess the safety in use of a new drug (administered on its own or combined with another therapy), what happens to it in the body, the possible adverse effects in man, and to acquire initial information about its anti-tumour activity.   

At Gustave Roussy early trials are conducted by the Department of Therapeutic Innovations and Early Trials (DITEP).

There is good reason to be hopeful. The outcome of phase I clinical trials is regression or stabilisation of disease in almost 50% of patients.  

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Participating in an early trial

Participating in an early trial enables one to have access to a new treatment while simultaneously contributing to the development of new anti-cancer therapies. Each drug to be assessed will have been meticulously tested in advance in a laboratory and each trial is conducted in man only when there is adequate evidence on safety in use of the new drug.    
> See the list of ongoing early trials

These new treatments are generally offered to patients:

  • when they represent a justified therapeutic alternative,
  • or when conventional treatment has not been effective.  

But also, with eligibility conditions, in particular:

  • a good level of general health (WHO performance score 0 or 1),
  • normal cardiac, renal, liver and haematological function,
  • no major co-morbidity.

Your participation in a clinical trial is voluntary and without constraint. It requires written consent. You may leave the study at any time without having to give a reason.    


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