Early-phase clinical trials (Phase I)

 Toward New Treatments

An early-phase clinical trial (or Phase I trial) involves evaluating the safety of a new compound (administered alone or in combination with another therapy), its behavior in the body, any adverse effects it may cause in humans, and to gather initial data on its antitumor activity.

Early-phase trials are conducted at Gustave Roussy by the Department of Therapeutic Innovation and Early-Phase Trials (DITEP).

There is real hope. At the end of a Phase I clinical trial, the disease regresses or stabilizes in nearly 50% of patients.

Play video - Qu'est-ce qu'un essai thérapeutique de phase I ?

Participating in an early-phase clinical trial

Participating in an early-phase trial provides access to an innovative treatment while contributing to the development of new cancer therapies. Each molecule being evaluated has been thoroughly tested in the laboratory beforehand, and each trial is conducted in humans only when there is sufficient evidence regarding the safety of the new drug.

→ See the list of ongoing

early-phase trials These new treatments are generally offered to patients:

• when they represent a justified therapeutic alternative,
• or when conventional treatments have not been effective.

But also, subject to eligibility criteria, including:

• good overall health (PS O or 1),
• preserved cardiac, renal, hepatic, and hematologic function,
• and the absence of major comorbidities.

Your participation in a clinical trial is voluntary and requires written consent. You may withdraw from the study at any time, without having to provide a reason.

Early-phase clinical trials: your journey in detail

Play video - Essais thérapeutique de phase I : votre parcours détaillé

To find out if you are eligible for an early-phase clinical trial, your oncologist must:

• Submit a digital request via Klineo (recommended)
• Or fill out a pre-screening form (This link will be deactivated shortly).

Once all of these documents have been received, your application will be carefully reviewed to determine whether you are eligible for an early-phase clinical trial. In any case, a response will be sent to your oncologist as soon as possible.

Your Responsibilities

To participate in this clinical trial, you must be enrolled in a social security program (including Universal Health Coverage—CMU) or be covered by a similar health insurance plan. For international patients, only European Union nationals may be eligible to participate, provided they obtain an E112 (S2) form validated by the EU country of which the patient is a national.

Your Commitments

If you decide to participate in a Phase I study, you will be asked to:

• attend all appointments scheduled by your doctor or members of their team;
• inform your doctor of all other medications you are taking, even if they are over-the-counter medications;
• inform your doctor of any medical conditions you have;
• use an effective method of contraception if you or your partner are of childbearing age;
• not become pregnant for the duration of the study and for several months (the duration varies depending on the study) after your participation in the study ends.

Before giving your consent to participate in the clinical trial, please be aware that no travel voucher will be issued to reimburse your travel expenses related to this trial. This is because clinical trials and the services associated with them are not covered by health insurance, pursuant to the provisions of Article L.321-1 of the Social Security Code. However, in certain clinical trials sponsored by a pharmaceutical company, you may be reimbursed for all transportation costs, but you will need to pay them upfront. If these costs are covered by the company, the doctor will provide you with the necessary reimbursement forms. It is therefore important that you discuss this with the doctor before enrolling in the study.

The Regulatory Framework

Clinical trials are strictly regulated. Before it begins, every biomedical research protocol must be approved by an Ethics Review Board (CPP) and by the French National Agency for Medicines and Health Products Safety (ANSM). This protocol must also comply with regulations regarding the protection of personal data.

Protection of Your Personal Data

Confidentiality and Anonymity

Your participation in this study involves the collection and use of certain personal data for scientific analysis. Gustave Roussy is committed to taking all necessary measures to ensure the confidentiality of your data. Access to your personal information is strictly limited to: Gustave Roussy staff, partners, service providers, and health authorities involved in this study.

Your Rights

You have the right to access, correct, transfer, object to the processing of, restrict the processing of, and have your personal data erased. You may exercise your rights at any time by contacting the principal investigator or Gustave Roussy’s data protection officer*.

You may ask the principal investigator to ensure that your primary care physician is not informed of your participation in this study. You may ask the principal investigator to be informed of the overall results of this study upon its completion.

Finally, the reuse of your personal data for future scientific research will only be permitted if you have been informed in advance by the study sponsor.

* Contact the Data Protection Officer:

• By mail:
  Institut Gustave Roussy,
  Data Protection Officer,
  Digital Transformation and Information
  Systems Department, 114 Rue Edouard-Vaillant,
  94 805 Villejuif
• or by email: donneespersonnelles@gustaveroussy.fr

What should you do if you experience side effects?

Contact your DITEP-assigned oncologist as soon as possible.

Weekdays from 9 a.m. to 5 p.m.

Nursing
Station Tel: +33 (0)1 42 11 43 27

Evenings and weekends only

Emergency
Room Tel: +33 (0)1 42 11 50 00

DITEP
On-Call Cell Phone: +33 (0)7 77 70 13 02