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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.

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

Tracking Information
First Submitted Date  ICMJE January 31, 2017
First Posted Date  ICMJE February 2, 2017
Last Update Posted Date February 25, 2021
Actual Study Start Date  ICMJE July 4, 2017
Estimated Primary Completion Date July 30, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (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  ICMJE 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  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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  ICMJE Advanced Solid Tumors Which Are cMET-dependent
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 21, 2017)
40
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2017)
60
Estimated Study Completion Date  ICMJE July 30, 2027
Estimated Primary Completion Date July 30, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Novartis Pharmaceuticals 1-888-669-6682 trialandresults.registries@novartis.com
Contact: Novartis Pharmaceuticals +41613241111 Novartis.email@novartis.com
Listed Location Countries  ICMJE Canada,   Denmark,   France,   Germany,   Italy,   Korea, Republic of,   Singapore,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03040973
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: Undecided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Toni Wozniak, MD Barbara Ann Karmanos Cancer Institute
PRS Account Novartis
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP