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

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03040973
Collaborator
(none)
40
12
3
120.8
3.3
0

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
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Multi-center, Global, Rollover Study for Patients Who Have Previously Been Treated With Capmatinib (INC280) as Monotherapy or in Combination in a Novartis Sponsored Trial.
Actual Study Start Date :
Jul 4, 2017
Anticipated Primary Completion Date :
Jul 30, 2027
Anticipated Study Completion Date :
Jul 30, 2027

Arms and Interventions

Arm Intervention/Treatment
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:
  • INC280
  • 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:
  • INC280
  • Drug: Nazartinib
    Capsule for oral use 25 mg, 50 mg, once a day
    Other Names:
  • EGF816
  • 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:
  • INC280
  • Drug: Gefitinib
    tablets for oral use 250mg once a day

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    • 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.

    • 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.

    • 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.

    • 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).

    1. Concurrent participation in another clinical study other than a parent clinical study

    2. 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
    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.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT03040973
    Other Study ID Numbers:
    • CINC280A2X02B
    • 2016-005144-42
    First Posted:
    Feb 2, 2017
    Last Update Posted:
    Jul 5, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Novartis Pharmaceuticals
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 5, 2022