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Study of Entrectinib for Patients with Advanced or Metastatic Solid Tumors with Specific Gene Changes

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What is this study about?

This clinical trial is focused on studying the effects of a medication called entrectinib, also known by its code name RO7102122. The study is designed for patients with certain types of advanced or spreading solid tumors. These tumors have specific changes in their genes, known as NTRK1/2/3, ROS1, or ALK gene rearrangements. These gene changes can lead to the growth of cancer cells, and the study aims to see how well entrectinib can target and treat these tumors.

The purpose of the study is to determine how well entrectinib works in treating these specific types of tumors. Participants in the study will take entrectinib in the form of hard capsules, which are taken by mouth. The study will observe how the tumors respond to the treatment over time. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of entrectinib. The study will also monitor the safety of the medication and any side effects that may occur.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the progress of their tumors. The study will collect information on how long the response to the treatment lasts, the time it takes for the treatment to start working, and the overall survival of the participants. Additionally, the study will look at how the treatment affects the quality of life and health status of the participants. This research aims to provide valuable insights into the effectiveness of entrectinib for treating these specific genetic changes in tumors.

1 joining the study

Upon joining the study, a diagnosis of a locally advanced or metastatic solid tumor with specific gene rearrangements is confirmed. This includes NTRK1/2/3, ROS1, or ALK gene rearrangements.

Eligibility is determined based on the ability to swallow the medication, adequate liver function, and other health criteria.

2 medication administration

The medication used in this study is Rozlytrek, which contains the active substance entrectinib. It is administered in the form of 200 mg hard capsules.

The capsules are taken orally, and it is important to swallow them whole without chewing, crushing, or opening them.

3 treatment schedule

The treatment involves taking the medication as prescribed by the study protocol. The specific dosage and frequency will be provided by the study team.

The duration of the treatment will continue as long as it is deemed beneficial and safe, or until the study concludes.

4 monitoring and assessments

Regular assessments will be conducted to monitor the response to the treatment. This includes measuring the size of the tumor and checking for any changes.

Additional tests may include imaging studies and laboratory tests to evaluate overall health and the effect of the medication.

5 end of study participation

Participation in the study will end either when the treatment is no longer effective, if there are significant side effects, or when the study reaches its conclusion.

Upon completion, a final assessment will be conducted to evaluate the overall response to the treatment.

Who Can Join the Study?

  • Must have a confirmed diagnosis of a locally advanced or metastatic solid tumor with specific gene changes (NTRK1/2/3, ROS1, or ALK) that can lead to a certain type of protein. This must be determined by specific testing methods. Patients should not have other major cancer-driving genes and should not have other effective treatment options available.
  • Must have an ECOG performance status of 2 or less, which means the patient should be able to carry out all self-care but unable to carry out any work activities. Must have a life expectancy of at least 4 weeks.
  • Must have adequate liver function, meaning certain liver enzymes and bilirubin levels should be within specified limits.
  • Women who can have children must have a negative pregnancy test, not be breastfeeding, and agree to use effective birth control methods during the study and for a period after the study. Men with partners who can have children must also use effective birth control and agree not to donate sperm during and after the study.
  • Must be able to swallow the study medication whole without altering the capsules.
  • For those tested locally, a sample of the tumor tissue must be submitted for further testing unless it’s not medically possible.
  • Must have a measurable disease as determined by specific criteria. Patients with non-measurable disease can still participate but will mainly help assess safety and other study aspects.
  • Patients with CNS involvement (cancer spread to the brain or spinal cord) that is controlled or not causing symptoms can participate. Certain medications for seizures are allowed.
  • Previous cancer treatments are allowed, except for specific inhibitors if the tumor has certain gene changes. The study is not enrolling new patients for the ALK group.
  • Must wait at least 2 weeks or 5 half-lives (whichever is shorter) after previous chemotherapy or targeted therapy before starting the study medication. There should be no worsening of the disease after stopping previous targeted therapies.
  • Must wait at least 4 weeks after finishing antibody-based therapy before starting the study medication.
  • Previous radiotherapy is allowed if it ended more than 14 days before starting the study medication. For brain radiation, whole brain treatment must be completed at least 14 days prior, and specific targeted brain treatment at least 7 days prior.
  • Must be at least 18 years old.

Who Cannot Join the Study?

  • Patients who do not have a type of cancer called solid tumors with specific gene changes (NTRK1/2/3, ROS1, or ALK) cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial groups cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Technische Universitaet Dresden Dresden Germany
Comite Entreprise Paul Papin Angers France
Universitaetsmedizin Goettingen Goettingen Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Netherlands Cancer Institute Amsterdam The Netherlands
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Santa Maria Della Misericordia Perugia Italy
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH Berlin Germany
Hospital Universitario Ramon Y Cajal Madrid Spain
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Universita’ Di Pisa Pisa Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Institut de Cancérologie de l’Ouest Saint-Herblain France
Hospital Universitario Virgen De La Victoria Malaga Spain
Caenpo Lkdg Bgyczu Lyon France
Idsludso Bvgdgxqa Bordeaux France
Ufcxohwzdl Hjdyzkkf Cavxakr Cologne Germany
Auqgsbqtnz Pkoisdwy Htdjalnb Dg Mujbcivhp Marseille France
Nftpacku Ispydzoo Ovzaocsub Iui Mjkdf Swggguemddeudrlprrfewymdmvpu Ibjaunds Bkoaglym Cracow Poland
Udfbwbhjygyffg Coietzg Krkcjmpeo Gdansk Poland
Htroxpvx Vqko doyrtmis Barcelona Spain
Ixdlbyrl Cosvh Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
19.11.2015
Germany Germany
Not recruiting
19.11.2015
Italy Italy
Not recruiting
19.11.2015
Poland Poland
Not recruiting
19.11.2015
Spain Spain
Recruiting
19.11.2015
The Netherlands The Netherlands
Not recruiting
19.11.2015

Trial locations

Investigated drugs:

Entrectinib is a medication being studied for its effectiveness in treating patients with certain types of advanced or metastatic solid tumors. These tumors have specific genetic changes known as NTRK1/2/3, ROS1, or ALK gene rearrangements. The goal of using Entrectinib in this trial is to see how well it can reduce the size of these tumors or stop them from growing.

Locally Advanced or Metastatic Solid Tumors with NTRK1/2/3, ROS1, or ALK Gene Rearrangements – These are a group of cancers that have spread beyond their original site and are characterized by specific genetic changes involving the NTRK1, NTRK2, NTRK3, ROS1, or ALK genes. These gene rearrangements can lead to uncontrolled cell growth and tumor development. The progression of these tumors can vary depending on the type of solid tumor and the specific gene rearrangement involved. They may affect various organs and tissues, leading to diverse symptoms based on the tumor’s location and size. The presence of these genetic alterations can influence the behavior of the cancer and its response to certain treatments. Understanding these genetic changes is crucial for developing targeted therapies.

Trial ID:
2023-505034-10-00
Protocol code:
GO40782
NCT ID:
NCT02568267
Trial Phase:
Therapeutic exploratory (Phase II)

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