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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT03040973

Studienbeginn:
Juli 2017

Letztes Update:
01.03.2024

Wirkstoff:
Capmatinib, Nazartinib, Gefitinib, Osimertinib

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Novartis Pharmaceuticals

Collaborator:
-

Studienleiter

Toni Wozniak, MD
Principal Investigator
Barbara Ann Karmanos Cancer Institute

Kontakt

Studienlocations
(3 von 15)

Novartis Investigative Site
01307 Dresden
(Sachsen)
GermanyZurückgezogen» Google-Maps
Novartis Investigative Site
30625 Hannover
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Novartis Investigative Site
50937 Koeln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Novartis Investigative Site
T6G 1Z2 Edmonton
CanadaAbgeschlossen» Google-Maps
Novartis Investigative Site
DK-2100 Copenhagen
DenmarkAbgeschlossen» Google-Maps
Novartis Investigative Site
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Novartis Investigative Site
05505 Seoul
Korea, Republic ofZurückgezogen» Google-Maps
Novartis Investigative Site
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Novartis Investigative Site
119074 Singapore
SingaporeRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed 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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability (Time Frame - Day 1 up to 10 years, assessed every 12 weeks):
Collection of adverse events and serious adverse events at every visit. Safety assessment will be performed and include local laboratory test monitoring in addition to local standard of care assessments.

Studien-Arme

  • Experimental: Capmatinib
    Starting dose of study treatment for patients in this protocol should be the same as the dose provided in the parent protocol at the time when the rollover protocol is initiated. Dose modifications are permitted.
  • Experimental: Capmatinib + Nazartinib
    Starting dose of the study treatment for patients should be the same as the dose provided in the parent protocol at the time when the rollover protocol is initiated. Dose modifications are permitted.
  • Experimental: Capmatinib + Gefitinib
    Starting dose of the study treatment for patients in this protocol should be the same as the dose provided in the parent protocol at the time when the rollover protocol is initiated. Dose modifications are permitted.
  • Experimental: Capmatinib + Osimertinib
    Starting dose of the study treatment for patients in this protocol should be the same as the dose provided in the parent protocol at the time when the rollover protocol is initiated. Dose modifications are permitted.

Geprüfte Regime

  • Capmatinib (INC280):
    Tablet for oral use; 150 mg, 200 mg; twice a day
  • Nazartinib (EGF816):
    Capsule for oral use; 25 mg, 50 mg; once a day
  • Gefitinib:
    tablets for oral use; 250mg; once a day
  • Osimertinib:
    Tablets for oral use; 40 mg, 80 mg; once a day.

Quelle: ClinicalTrials.gov


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