Long-Term Safety Study of Dabrafenib Mesylate and Trametinib Dimethyl Sulfoxide for Patients Benefiting from Previous Treatment in Multiple Indications

3 1 1 1

What is this study about?

This clinical trial is focused on patients with various types of cancer who are currently benefiting from treatment with the medications dabrafenib and/or trametinib. These medications are used to treat certain types of cancer by targeting specific proteins in cancer cells, which can help slow down or stop the growth of the cancer. The study aims to provide continued access to these treatments for patients who have been part of previous studies sponsored by Novartis or GSK and are still experiencing benefits from the treatment.

The purpose of the study is to assess the long-term safety of these medications. Participants will continue to receive their current treatment, either as a single medication or in combination, depending on what they were receiving in the previous study. The study will monitor the occurrence of any side effects or adverse events to ensure the ongoing safety of the treatment. Patients will have regular check-ups with their healthcare providers to evaluate their health and the effectiveness of the treatment.

This study is designed for patients who have already been receiving dabrafenib and/or trametinib and have shown compliance with the treatment plan. The study will continue until the end of 2027, allowing patients to maintain their treatment regimen under the supervision of their healthcare team. The goal is to ensure that patients who are benefiting from these medications can continue to do so safely over a longer period.

1 joining the study

Upon joining the study, the patient must provide written informed consent. This consent confirms understanding and agreement to participate in the study.

The patient must be currently receiving treatment with either dabrafenib or trametinib, or both, as part of a previous study sponsored by Novartis or GSK.

2 treatment continuation

The patient will continue taking the medications dabrafenib and/or trametinib as prescribed. These medications are taken orally.

Dabrafenib is provided in the form of a hard capsule, while trametinib is provided as a film-coated tablet.

3 scheduled visits

The patient must attend scheduled visits as part of the study requirements. These visits are necessary to monitor the patient’s health and the effects of the medication.

During these visits, the investigator will assess the patient’s clinical benefit from the treatment.

4 safety monitoring

The primary objective of the study is to evaluate the long-term safety of the treatment. This involves monitoring for any adverse events (AEs) or serious adverse events (SAEs).

The frequency and severity of these events will be recorded and assessed.

5 study duration

The study is estimated to conclude by December 21, 2027. The patient will continue to receive treatment and attend visits until the study ends or until the investigator determines that the patient no longer benefits from the treatment.

Who Can Join the Study?

  • The patient is currently receiving treatment with dabrafenib and/or trametinib either alone or together in a study sponsored by Novartis or former GSK, which has met the main study goals. Dabrafenib and trametinib are medications used to treat certain types of cancer.
  • The study doctor believes the patient would benefit from continuing the treatment.
  • The patient has followed the rules and requirements of the original study, as checked by the study doctor.
  • The patient is willing and able to attend scheduled visits, follow treatment plans, and participate in other study procedures.
  • The patient has provided written informed consent before joining the new study and receiving the study medication. If the patient cannot provide written consent, it must be formally documented and witnessed, preferably by an independent trusted person.
  • The patient does not need treatment with medications that are not allowed during the study.

Who Cannot Join the Study?

  • Patients who are not within the specified age range for the study.
  • Patients who have medical conditions that are not suitable for the study.
  • Patients who are part of a vulnerable population that the study cannot safely include.
  • Patients who have experienced certain side effects or serious side effects in the past that may affect their safety in the study.
  • Patients who are not able to follow the study procedures or instructions.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of certain medical conditions that could interfere with the study results.
  • Patients who are pregnant or breastfeeding, as the study may not be safe for them.
  • Patients who have allergies or reactions to the study medication or similar medications.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
Institut Gustave Roussy Villejuif France
Hospital Universitario Hm Sanchinarro Madrid Spain
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Hospital Universitario Y Politecnico La Fe Valencia Spain
Institut Curie – Site Paris Paris France

Other Sites

Site Name City Country Status
Orszagos Onkologiai Intezet Budapest Hungary
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Universitaetsklinikum Mannheim GmbH Mannheim Germany
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Centre Hospitalier Universitaire De Nantes Nantes France
Rigshospitalet Copenhagen Denmark
Hospital General Universitario Gregorio Maranon Madrid Spain
University Of Debrecen Debrecen Hungary
Cewnda Lbsu Bzbjuy Lyon France
Udaapowjdv Mdgkhaj Cdbnle Hfvqyqfugozghcpai Hamburg Germany
Ueksdsbwrguyvhsnhpqoy Eexbc Aph Essen Germany
Uuvtnduehunhhlotrwkiu Amynfzem Augsburg Germany
Hoszcmwo Vozq dubollff Barcelona Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
15.01.2018
Denmark Denmark
Recruiting
15.01.2018
France France
Recruiting
15.01.2018
Germany Germany
Recruiting
15.01.2018
Hungary Hungary
Not recruiting
15.01.2018
Spain Spain
Recruiting
15.01.2018
The Netherlands The Netherlands
Recruiting
15.01.2018

Trial locations

Tafinlar is a medication used in this trial to help treat certain types of cancer. It works by targeting and blocking specific proteins in cancer cells, which can slow down or stop the growth of the cancer.

Mekinist is another medication involved in the trial. It is used alongside Tafinlar to treat cancer by inhibiting different proteins that are involved in the growth and spread of cancer cells. This combination aims to improve the effectiveness of the treatment.

Investigated diseases:

Multiple Sclerosis – Multiple sclerosis is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It involves an abnormal immune response that damages the protective covering of nerve fibers, leading to communication problems between the brain and the rest of the body. Symptoms can vary widely, including fatigue, difficulty walking, numbness, and muscle weakness. The disease often progresses with periods of relapses and remissions, but some individuals may experience a steady worsening of symptoms over time. The exact cause of multiple sclerosis is unknown, but it is believed to involve genetic and environmental factors.

Trial ID:
2023-509318-13-00
Protocol code:
CDRB436X2X02B
NCT ID:
NCT03340506
Trial Phase:
Therapeutic confirmatory (Phase III)

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