Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving Capmatinib Treatment as Single Agent or in Combination With Other Treatments or the Combination Treatment Alone

Last updated: April 16, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Nazartinib

Gefitinib

Osimertinib

Clinical Study ID

NCT03040973
CINC280A2X02B
2016-005144-42
  • Ages 18-100
  • All Genders

Study Summary

The purpose of this study is to assess long-term safety and provide continued study treatment access to eligible participants who are judged by the Investigator to benefit from continued treatment with capmatinib monotherapy or in combination with other treatments or with the combination treatment alone in a Novartis sponsored study

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. Participant is currently receiving capmatinib treatment (within Novartis-sponsoredstudy which is eligible and approved to transition participants to rollover study)as single agent or in combination or is receiving a combination treatment alone.This includes all participants treated with capmatinib in combination with othertreatment that permanently discontinued capmatinib for any reason but are stillreceiving the combination treatment as single agent. In order to receive thecombination treatment as single agent in the rollover study, the treatment needs tobe not accessible to the participant outside a clinical trial (e.g. commercially notavailable or reimbursed).

  2. Participant is currently deriving clinical benefit from study treatment asdetermined by the Investigator

  3. Willingness and ability to comply with scheduled visits, treatment plans and anyother study procedures

  4. Written informed consent obtained prior to enrolling in the rollover study andreceiving study medication. If consent cannot be expressed in writing, it must beformally documented and witnessed, ideally via an independent trusted witness.

Exclusion

Exclusion criteria:

  1. Participant is currently not receiving any study treatment due to unresolvedtoxicities for which study treatment dosing has been interrupted or permanentlydiscontinued in the parent protocol (participants meeting all other eligibilitycriteria may be enrolled once toxicities have resolved to allow study treatmentdosing to resume)

  2. Pregnant or nursing (lactating) women

  3. Women of child-bearing potential, defined as all women physiologically capable ofbecoming pregnant, unless they are using highly effective methods of contraceptionwhile taking study treatment and for at least 7 days or following combinationtreatment parent trial recommendation (whichever is longer) of study treatment afterstopping medication. Highly effective contraception methods include:

  4. Concurrent participation in another clinical study other than a parent clinicalstudy

  5. Participants who received live vaccines (e.g., intranasal influenza, measles, mumps,rubella, oral polio, BCG, yellow fever, varicella, TY21a typhoid vaccines andCOVID-19 vaccines) within 30 days prior to the first dose of study treatment

Study Design

Total Participants: 40
Treatment Group(s): 4
Primary Treatment: Nazartinib
Phase: 2
Study Start date:
July 04, 2017
Estimated Completion Date:
July 30, 2027

Study Description

This is an open-label, multi-center, rollover study to assess long-term safety in participants who have completed a prior Novartis-sponsored study, that have fulfilled the eligibility requirements and are judged by the Investigator to benefit from continued treatment with capmatinib given as monotherapy or in combination with other treatments or with the combination treatment alone.

There will be no screening period for this study. After providing informed consent, all eligible participants will begin their treatment within the rollover study. Participants should return to the study center for resupply of the study medication/s and for safety assessment following the usual local practice. During a public health emergency as declared by local or regional authorities (i.e. pandemic, epidemic or natural disaster) that limits or prevents on-site study visits, alternative methods of providing continuing care may be implemented by the Investigator as the situation dictates.

Participants will continue to be treated until they are no longer benefitting from the study treatment in the opinion of the treating physician, develop unacceptable toxicities that preclude further treatment with the study treatment, disease progression, withdrawal of consent, discontinuation at the discretion of the Investigator, initiation of new anticancer therapy, until the study treatment is commercially available and reimbursed or/and available under any other local mechanism (such as compassionate use, named patient program) for the appropriate indication and/or discontinuation for any other reason. Participants receiving capmatinib as part of a combination therapy could continue treatment only with capmatinib or with the combination treatment as single agent in case one of the two compounds is permanently discontinued, if in the opinion of the treating physician they are still benefitting from the treatment.

A patient will reach the end of rollover study when study treatment is permanently discontinued and the end of treatment visit has been performed. All participants will be followed up for safety for 30 days after the last dose of study treatment or until SAE is resolved as required, whichever is later.

The study is expected to remain open for up to 10 years or until such time that all enrolled participants no longer need treatment with study treatment(s) or Novartis decides to stop the development program, whichever comes first.

Connect with a study center

  • Novartis Investigative Site

    Leuven, 3000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Edmonton, Alberta T6G 1Z2
    Canada

    Completed

  • Novartis Investigative Site

    Shanghai, Shanghai 200433
    China

    Active - Recruiting

  • Novartis Investigative Site

    Copenhagen, DK-2100
    Denmark

    Completed

  • Novartis Investigative Site

    Kobenhavn O, DK-2100
    Denmark

    Site Not Available

  • Novartis Investigative Site

    Dijon, Cote D Or 21034
    France

    Completed

  • Novartis Investigative Site

    Dijon Cedex, Cote D Or 21034
    France

    Site Not Available

  • Novartis Investigative Site

    Dresden, 01307
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hannover, 30625
    Germany

    Site Not Available

  • Novartis Investigative Site

    Koeln, 50937
    Germany

    Site Not Available

  • Novartis Investigative Site

    Milano, MI 20141
    Italy

    Site Not Available

  • Novartis Investigative Site

    Perugia, PG 06129
    Italy

    Completed

  • Novartis Investigative Site

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Novartis Investigative Site

    Singapore, 119074
    Singapore

    Site Not Available

  • Novartis Investigative Site

    Madrid, 28040
    Spain

    Completed

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Massachusetts General Hospital MGH Cancer Center

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Site Not Available

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