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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 : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Which Are cMET-dependent Drug: capmatinib Drug: Nazartinib Drug: Gefitinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
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 : July 4, 2017
Estimated Primary Completion Date : July 30, 2027
Estimated Study Completion Date : July 30, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: capmatinib
tablet for oral use 400 mg BID
Other Name: INC280

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.
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

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.
Drug: capmatinib
tablet for oral use 400 mg BID
Other Name: INC280

Drug: Gefitinib
tablets for oral use 250mg QD




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040973


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 trialandresults.registries@novartis.com
Contact: Novartis Pharmaceuticals +41613241111 Novartis.email@novartis.com

Locations
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United States, Massachusetts
Massachusetts General Hospital MGH Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Alexander Kendall Turney       AKTURNEY@mgh.harvard.edu   
Principal Investigator: Rebecca Heist         
Canada, Alberta
Novartis Investigative Site Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Denmark
Novartis Investigative Site Completed
Copenhagen, Denmark, DK-2100
France
Novartis Investigative Site Completed
Dijon Cedex, Cote D Or, France, 21034
Germany
Novartis Investigative Site Withdrawn
Dresden, Germany, 01307
Novartis Investigative Site Recruiting
Hannover, Germany, 30625
Novartis Investigative Site Recruiting
Koeln, Germany, 50937
Italy
Novartis Investigative Site Recruiting
Perugia, PG, Italy, 06129
Korea, Republic of
Novartis Investigative Site Recruiting
Seoul, Korea, Republic of, 03080
Novartis Investigative Site Withdrawn
Seoul, Korea, Republic of, 05505
Singapore
Novartis Investigative Site Recruiting
Singapore, Singapore
Spain
Novartis Investigative Site Completed
Madrid, Spain, 28040
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Principal Investigator: Toni Wozniak, MD Barbara Ann Karmanos Cancer Institute
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03040973    
Other Study ID Numbers: CINC280A2X02B
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
capmatinib
Nazartinib
Gefitinib
rollover protocol
parent study
Additional relevant MeSH terms:
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Gefitinib
(R,E)-N-(7-chloro-1-(1-(4-(dimethylamino)but-2-enoyl)azepan-3-yl)-1H-benzo(d)imidazol-2-yl)-2-methylisonicotinamide
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action