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Trial record 3 of 5 for:    Nazartinib | Phase 2
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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

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ClinicalTrials.gov Identifier: NCT03040973
Recruitment Status : Recruiting
First Posted : February 2, 2017
Last Update Posted : March 1, 2024
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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
Advanced Solid Tumors Which Are cMET-dependent Drug: Capmatinib Drug: Nazartinib Drug: Gefitinib Drug: Osimertinib Phase 2

Detailed Description:

This is an open-label, multi-center, rollover study to assess long-term safety in participants who have completed a prior Novartis-sponsored study, that have fulfilled the eligibility requirements and are judged by the Investigator to benefit from continued treatment with capmatinib given as monotherapy or in combination with other treatments or with the combination treatment alone.

There will be no screening period for this study. After providing informed consent, all eligible participants will begin their treatment within the rollover study. Participants should return to the study center for resupply of the study medication/s and for safety assessment following the usual local practice. During a public health emergency as declared by local or regional authorities (i.e. pandemic, epidemic or natural disaster) that limits or prevents on-site study visits, alternative methods of providing continuing care may be implemented by the Investigator as the situation dictates.

Participants will continue to be treated until they are no longer benefitting from the study treatment in the opinion of the treating physician, develop unacceptable toxicities that preclude further treatment with the study treatment, disease progression, withdrawal of consent, discontinuation at the discretion of the Investigator, initiation of new anticancer therapy, until the study treatment is commercially available and reimbursed or/and available under any other local mechanism (such as compassionate use, named patient program) for the appropriate indication and/or discontinuation for any other reason. Participants receiving capmatinib as part of a combination therapy could continue treatment only with capmatinib or with the combination treatment as single agent in case one of the two compounds is permanently discontinued, if in the opinion of the treating physician they are still benefitting from the treatment.

A patient will reach the end of rollover study when study treatment is permanently discontinued and the end of treatment visit has been performed. All participants will be followed up for safety for 30 days after the last dose of study treatment or until SAE is resolved as required, whichever is later.

The study is expected to remain open for up to 10 years or until such time that all enrolled participants no longer need treatment with study treatment(s) or Novartis decides to stop the development program, whichever comes first.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : 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

Drug Information available for: Capmatinib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Capmatinib
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 Name: 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 Name: INC280

Drug: Nazartinib
Capsule for oral use; 25 mg, 50 mg; once a day
Other Name: EGF816
Experimental: Capmatinib + Gefitinib
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. Dose modifications are permitted.
 Drug: Capmatinib
Tablet for oral use; 150 mg, 200 mg; twice a day
Other Name: INC280

Drug: Gefitinib
tablets for oral use; 250mg; once a day
Experimental: Capmatinib + Osimertinib
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. Dose modifications are permitted.
 Drug: Capmatinib
Tablet for oral use; 150 mg, 200 mg; twice a day
Other Name: INC280

Drug: Osimertinib
Tablets for oral use; 40 mg, 80 mg; once a day.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Day 1 up to 10 years, assessed every 12 weeks ]
    Collection of adverse events and serious adverse events at every visit. Safety assessment will be performed and include local laboratory test monitoring in addition to local standard of care assessments.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:
  4. Concurrent participation in another clinical study other than a parent clinical study
  5. 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
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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 Novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
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United States, Massachusetts
Massachusetts General Hospital MGH Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Julia K Digiovanni       JKDigiovanni@mgh.harvard.edu   
Principal Investigator: Rebecca Heist         
Belgium
Novartis Investigative Site Recruiting
Leuven, Belgium, 3000
Canada, Alberta
Novartis Investigative Site Completed
Edmonton, Alberta, Canada, T6G 1Z2
Denmark
Novartis Investigative Site Completed
Copenhagen, Denmark, DK-2100
France
Novartis Investigative Site Completed
Dijon, 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
Milano, MI, Italy, 20141
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
Novartis Investigative Site Recruiting
Seoul, Korea, Republic of, 05505
Singapore
Novartis Investigative Site Recruiting
Singapore, Singapore, 119074
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
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03040973    
Other Study ID Numbers: CINC280A2X02B
2016-005144-42 ( EudraCT Number )
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: March 1, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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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 ):
Nazartinib
capmatinib
INC280
Gefitinib
Osimertinib
EGF816
NSCLC
 EGFR inhibitor
METex14
Non Small Cell Lung Cancer
MET inhibitors
rollover protocol
parent protocol
Additional relevant MeSH terms:
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Gefitinib
Osimertinib
Nazartinib
Tyrosine Kinase Inhibitors
 Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents