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Cancer patients on targeted therapy get extended safety monitoring

NCT ID NCT03340506

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 10 times

Summary

This study provides continued access to dabrafenib and/or trametinib for up to 100 patients with melanoma, lung cancer, or other solid tumors who were benefiting from these drugs in a prior Novartis or GSK trial. The main goal is to track long-term side effects and safety over time. Participants must have completed the main goals of their earlier study and be judged by their doctor as likely to benefit from ongoing treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2018

Expected to finish

Dec 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient is currently receiving treatment with dabrafenib/trametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective. * In the opinion of the Investigator would benefit from continued treatment. Exclusion Criteria: * Patient has been previously permanently discontinued from study treatment in the parent protocol. * Patient's indication is commercially available and reimbursed in the local country. * Patient currently has unresolved toxicities for which dabrafenib and/or trametinib dosing has been interrupted in the parent study.

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Conditions

The condition(s) this trial relates to.

glioma lung neoplasm malignant glioma melanoma neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

High grade glioma Melanoma Non-small cell lung cancer Rare cancers Solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Honor Health Research Institute

    ACTIVE_NOT_RECRUITING

    Scottsdale, Arizona, 85258, United States

  • James Cancer Hospital and Solove Research Institute Ohio State

    COMPLETED

    Columbus, Ohio, 43210, United States

  • Mary Crowley Cancer Research

    COMPLETED

    Dallas, Texas, 75251, United States

  • National Institute Of Health

    ACTIVE_NOT_RECRUITING

    Bethesda, Maryland, 20892, United States

  • Novartis Investigative Site

    COMPLETED

    Caba, Buenos Aires, C1121ABE, Argentina

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Innsbruck, Tyrol, 6020, Austria

  • Novartis Investigative Site

    RECRUITING

    Toronto, Ontario, M5G 1X8, Canada

  • Novartis Investigative Site

    COMPLETED

    Beijing, 100036, China

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Copenhagen, 2100, Denmark

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Lyon, 69373, France

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Nantes, 44093, France

  • Novartis Investigative Site

    RECRUITING

    Paris, 75231, France

  • Novartis Investigative Site

    COMPLETED

    Paris, 75970, France

  • Novartis Investigative Site

    RECRUITING

    Villejuif, 94800, France

  • Novartis Investigative Site

    COMPLETED

    Mannheim, Baden-Wurttemberg, 68305, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Augsburg, 86179, Germany

  • Novartis Investigative Site

    COMPLETED

    Berlin, 13353, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Essen, 45147, Germany

  • Novartis Investigative Site

    COMPLETED

    Hamburg, 20246, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Hamburg, 20246, Germany

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Heidelberg, 69120, Germany

  • Novartis Investigative Site

    COMPLETED

    Debrecen, Hajdu Bihar Megye, 4032, Hungary

  • Novartis Investigative Site

    COMPLETED

    Budapest, 1122, Hungary

  • Novartis Investigative Site

    COMPLETED

    Kashiwa, Chiba, 2778577, Japan

  • Novartis Investigative Site

    COMPLETED

    Chuo Ku, Tokyo, 1040045, Japan

  • Novartis Investigative Site

    COMPLETED

    Rotterdam, South Holland, 3015 GD, Netherlands

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Utrecht, 3584 CX, Netherlands

  • Novartis Investigative Site

    RECRUITING

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28009, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28040, Spain

  • Novartis Investigative Site

    COMPLETED

    Madrid, 28041, Spain

  • Novartis Investigative Site

    RECRUITING

    Madrid, 28050, Spain

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Valencia, 46026, Spain

  • Novartis Investigative Site

    ACTIVE_NOT_RECRUITING

    Songkhla, Hat Yai, 90110, Thailand

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