Study to Allow Patients Previously Participating in a Novartis Sponsored Trial to Continue Receiving INC280 Treatment as Single Agent or in Combination With Other Treatments.

• Status: Recruiting
• Trial end date: 2027-07-30
• Target enrollment: 0
• Participant gender: All

Summary

The rollover study will provide continued treatment and assessment of long-term safety follow-up in patients receiving capmatinib (INC280) as a single agent or in combination with EGF816 or Gefitinib in a Novartis sponsored study and in the opinion of the Investigator would benefit from continued treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Gefitinib; Nazartinib

Criteria

Inclusion criteria:

1. Patient is currently receiving INC280 treatment (within an INC280 Novartis-sponsored study which is eligible and approved to transition patients to rollover study) as single agent or in combination or is receiving a combination treatment alone*. Please refer to the list of parent studies in Appendix 14.

*This includes all patients treated with INC280 in combination with other treatment that permanently discontinued INC280 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, treatment need to be not accessible to the patient outside a clinical trial (e.g. commercially not available or reimbursed).

2. Subject 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:

Patients eligible for this study must not meet any of the following criteria:

1. Patient is currently not receiving any study treatment due to unresolved toxicities for which study drug dosing has been interrupted or permanently discontinued in the parent protocol (Patients meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow study drug 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 during dosing and for 7 days after stopping treatment. Highly effective contraception methods include:

Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) total hysterectomy, or bilateral tubal ligation 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 subjects on the study the vasectomized male partner should be the sole partner for that subject Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system, 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 and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or bilateral tubal ligation at least six weeks before study entry. 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 not of child bearing potential. Sexually active males unless they use a condom during intercourse while taking drug and for 7 days after stopping treatment and should not father a child in this period. A condom is required to be used also by vasectomized men as well as during intercourse in order to prevent delivery of the drug via semen.

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