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
Study Details
Study Description
Brief 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
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Capmatinib The 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. |
Drug: Capmatinib
Tablet for oral use 150 mg, 200 mg, twice a day
Other Names:
|
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. |
Drug: Capmatinib
Tablet for oral use 150 mg, 200 mg, twice a day
Other Names:
Drug: Nazartinib
Capsule for oral use 25 mg, 50 mg, once a day
Other Names:
|
Experimental: Capmatinib + Gefitinib The 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. |
Drug: Capmatinib
Tablet for oral use 150 mg, 200 mg, twice a day
Other Names:
Drug: Gefitinib
tablets for oral use 250mg once a day
|
Outcome Measures
Primary Outcome Measures
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [Day 1 up to 5 years, assessed every 12 weeks]
Collection of adverse events and serious adverse events at every visit.
Eligibility Criteria
Criteria
Inclusion criteria:
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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).
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Participant is currently deriving clinical benefit from study treatment as determined by the Investigator
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Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures
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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:
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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)
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Pregnant or nursing (lactating) women
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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:
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Total 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.
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Female 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.
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Male 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.
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Use 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.
If local regulations are more stringent than the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the Informed Consent Form (ICF).
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Concurrent participation in another clinical study other than a parent clinical study
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Massachusetts General Hospital MGH Cancer Center | Boston | Massachusetts | United States | 02114 |
2 | Novartis Investigative Site | Edmonton | Alberta | Canada | T6G 1Z2 |
3 | Novartis Investigative Site | Copenhagen | Denmark | DK-2100 | |
4 | Novartis Investigative Site | Dijon Cedex | Cote D Or | France | 21034 |
5 | Novartis Investigative Site | Dresden | Germany | 01307 | |
6 | Novartis Investigative Site | Hannover | Germany | 30625 | |
7 | Novartis Investigative Site | Koeln | Germany | 50937 | |
8 | Novartis Investigative Site | Perugia | PG | Italy | 06129 |
9 | Novartis Investigative Site | Seoul | Korea, Republic of | 03080 | |
10 | Novartis Investigative Site | Seoul | Korea, Republic of | 05505 | |
11 | Novartis Investigative Site | Singapore | Singapore | ||
12 | Novartis Investigative Site | Madrid | Spain | 28040 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Principal Investigator: Toni Wozniak, MD, Barbara Ann Karmanos Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CINC280A2X02B
- 2016-005144-42