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.

• ClinicalTrials.gov Identifier: NCT03040973
• Recruitment Status: Recruiting
• First Posted: February 2, 2017
• Last Update Posted: February 25, 2021
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

Tracking Information

• First Submitted Date: January 31, 2017
• First Posted Date: February 2, 2017
• Last Update Posted Date: February 25, 2021
• Actual Study Start Date: July 4, 2017
• Estimated Primary Completion Date: July 30, 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 31, 2017)

Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Day 1 up to 5 years, assessed every 12 weeks ]

Collection of adverse events and serious adverse events at every visit.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: January 31, 2017)

Percentage of patients with clinical benefit [ Time Frame: Day 1 up to 5 years, assessed every 12 weeks ]

At scheduled visits (every 12 weeks) the Investigator will assess if patients continue to have clinical benefit

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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.
• 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.
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Single agent INC280 Combination of INC280 and EGF816 Combination of INC280 and Gefitinib

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Advanced Solid Tumors Which Are cMET-dependent

Intervention

• Drug: capmatinib
  tablet for oral use 400 mg BID
  Other Name: INC280
• Drug: Nazartinib
  Tablets/Capsules for oral use 100 mg QD
  Other Name: EGF816
• Drug: Gefitinib
  tablets for oral use 250mg QD

Study Arms

• Experimental: INC280
  The starting dose of study treatment for patients in this protocol should be the same as the dose provided in the parent INC280 protocol at the time when the rollover protocol is initiated. Dose modifications are permitted.
  Intervention: Drug: capmatinib
• Experimental: INC280/EGF816
  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.
  Interventions:

  • Drug: capmatinib
  • Drug: Nazartinib
• Active Comparator: INC280/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.
  Interventions:

  • Drug: capmatinib
  • Drug: Gefitinib

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 21, 2017): 40
• Original Estimated Enrollment (submitted: January 31, 2017): 60
• Estimated Study Completion Date: July 30, 2027
• Estimated Primary Completion Date: July 30, 2027 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No

Contacts

Contact: Novartis Pharmaceuticals; 1-888-669-6682; trialandresults.registries@novartis.com

Contact: Novartis Pharmaceuticals; +41613241111; Novartis.email@novartis.com

• Listed Location Countries: Canada, Denmark, France, Germany, Italy, Korea, Republic of, Singapore, Spain, United States

Administrative Information

• NCT Number: NCT03040973
• Other Study ID Numbers: CINC280A2X02B
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Novartis ( Novartis Pharmaceuticals )
• Study Sponsor: Novartis Pharmaceuticals
• Collaborators: Not Provided

Investigators

• Principal Investigator: Toni Wozniak, MD; Barbara Ann Karmanos Cancer Institute

• PRS Account: Novartis
• Verification Date: February 2021