Study Description
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 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.
Interventions
Capmatinib
Gefitinib
Nazartinib
Osimertinib
Eligibility Criteria
Inclusion criteria:
1. Participant is currently receiving capmatinib treatment (within Novartis-sponsored
study 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 other
treatment that permanently discontinued capmatinib for any reason but are still
receiving the combination treatment as single agent. In order to receive the
combination treatment as single agent in the rollover study, the treatment needs to
be not accessible to the participant outside a clinical trial (e.g. commercially not
available or reimbursed).
2. Participant is currently deriving clinical benefit from study treatment as
determined by the Investigator
3. Willingness and ability to comply with scheduled visits, treatment plans and any
other study procedures
4. Written informed consent obtained prior to enrolling in the rollover study and
receiving study medication. If consent cannot be expressed in writing, it must be
formally documented and witnessed, ideally via an independent trusted witness.
Exclusion criteria:
1. Participant is currently not receiving any study treatment due to unresolved
toxicities for which study treatment dosing has been interrupted or permanently
discontinued in the parent protocol (participants meeting all other eligibility
criteria may be enrolled once toxicities have resolved to allow study treatment
dosing to resume)
2. Pregnant or nursing (lactating) women
3. Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, unless they are using highly effective methods of contraception
while taking study treatment and for at least 7 days or following combination
treatment parent trial recommendation (whichever is longer) of study treatment after
stopping medication. Highly effective contraception methods include:
4. Concurrent participation in another clinical study other than a parent clinical
study
5. Participants who received live vaccines (e.g., intranasal influenza, measles, mumps,
rubella, oral polio, BCG, yellow fever, varicella, TY21a typhoid vaccines and
COVID-19 vaccines) within 30 days prior to the first dose of study treatment
Novartis Investigative Site
Recruiting
Hannover,30625,Germany
Novartis Investigative Site
Recruiting
Koeln,50937,Germany
Novartis Investigative Site
Recruiting
Seoul,03080,Korea, Republic of
Novartis Investigative Site
Recruiting
Seoul,05505,Korea, Republic of
Novartis Investigative Site
Recruiting
Singapore,119074,Singapore
Massachusetts General Hospital
Recruiting
Boston,Massachusetts,02114,United States
Julia K Digiovanni
Rebecca Heist
Worldwide Contacts
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