Capmatinib for cMET-dependent malignancies | Advanced cancer

Inclusion criteria

• {"criterion_text":"- 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"}
• {"criterion_text":"- Participant is currently deriving clinical benefit from study treatment as determined by the Investigator"}
• {"criterion_text":"- Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures"}
• {"criterion_text":"- 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

• {"criterion_text":"- 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)"}
• {"criterion_text":"- Pregnant or nursing (lactating) women"}
• {"criterion_text":"- 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: •\tTotal abstinence (when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception. •\tFemale bilateral tubal ligation, female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy or total hysterectomy at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment. •\tMale sterilization (at least 6 months prior to screening). For female participants on the study, the vasectomized male partner should be the sole partner for that participant. •\tUse of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age-appropriate history of vasomotor symptoms). Women are considered not of childbearing potential if they are post-menopausal or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks prior to enrollment on study. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered to be not of childbearing potential. Sexually active males unwilling to use a condom during intercourse while taking study treatment and for at least 7 days or following combination treatment of the parent trial combination recommendation (whichever is longer) after stopping study treatment. A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, male participants must not donate sperm for the time period specified above."}
• {"criterion_text":"- Concurrent participation in another clinical study other than a parent clinical study"}
• {"criterion_text":"- 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"}

Primary endpoints

• {"endpoint_text":"- Safety: Frequency and severity of AEs/SAEs","definition_or_measurement_approach":"To evaluate long term safety as assessed by the occurrence of AEs/SAEs; measured by frequency and severity of adverse events (AEs) and serious adverse events (SAEs)."}

Germany

Earliest CTIS Part Ii Submission Date

28-05-2024

Latest Decision Or Authorization Date

26-03-2025

Processing Time Days

302

Number Of Sites

2

Number Of Participants

4

Belgium

Earliest CTIS Part Ii Submission Date

28-05-2024

Latest Decision Or Authorization Date

22-12-2025

Processing Time Days

573

Number Of Sites

1

Number Of Participants

5

Italy

Earliest CTIS Part Ii Submission Date

28-05-2024

Latest Decision Or Authorization Date

14-04-2026

Processing Time Days

686

Number Of Sites

1

Number Of Participants

2

Primary sponsor

Full Name

Novartis Pharma AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

sponsorDuties code: 1

Name

Syneos Health Inc.

Responsibilities

sponsorDuties code: 1

Name

Parexel International (IRL) Limited

Responsibilities

sponsorDuties code: 12

Name

Opis S.r.l.

Responsibilities

sponsorDuties code: 15; TMF archive, Activation sites activities

Name

Mipharm S.p.A.

Responsibilities

sponsorDuties code: 15; Local drug supply, Local equipment storage

Name

IQVIA Limited

Responsibilities

sponsorDuties codes: 1, 3

Third parties

• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties code: 12","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Opis S.r.l.","duties_or_roles":"sponsorDuties code: 15; TMF archive, Activation sites activities","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Mipharm S.p.A.","duties_or_roles":"sponsorDuties code: 15; Local drug supply, Local equipment storage","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"sponsorDuties codes: 1, 3","organisation_type":"Pharmaceutical company"}