Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 28 of 37 for:    ALECTINIB

A Study to Determine Progression-free Survival and Evaluate Participant Experience for Participants With Metastatic Anaplastic Lymphoma Kinase-positive (ALK+) NSCLC Treated With ALK Inhibitors.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03546894
Recruitment Status : Recruiting
First Posted : June 5, 2018
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Brief Summary:
The primary purpose of this study is to determine the differences in progression-free survival (PFS) for participants who have been prescribed brigatinib as ALK inhibitor therapy for ALK+NSCLC compared to those participants who have been prescribed alectinib, ceritinib, or other ALK inhibitors that may become available during study treatment.

Condition or disease Intervention/treatment
Anaplastic Lymphoma Kinase-positive Carcinoma Non-small-cell Lung Drug: Brigatinib Drug: Alectinib Drug: Ceritinib Drug: Other ALK inhibitors

Detailed Description:

This is a prospective and non-interventional study of participants with ALK+NSCLC. The study will seek to determine the real-world differences in the PFS of participants taking ceritinib, alectinib, brigatinib, and other ALK inhibitors in routine clinical practice and will evaluate participant's quality of life, daily function, general condition, and treatment satisfaction.

The study will enroll approximately 400 participants: 120 participants each taking alectinib or ceritinib, 150 participants taking brigatinib, and 40 participants taking other ALK inhibitors. Participants will be enrolled in one of the 4 cohorts:

  • Brigatinib
  • Alectinib
  • Ceritinib
  • Other ALK inhibitors

This trial will be conducted in the United States. Upon enrollment into the study, participants will complete a study-specific Baseline questionnaire and four validated instrument questionnaires. After that, participants will complete a study-specific monthly questionnaire and four validated instrument questionnaires, which will be made available to participants every 30 days. Participants will be sent automatic e-mail reminders every 30 days when new surveys become available. All participants will receive a notice on completion of their participation in the study at approximately 18 months.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Parallel Group Phase 4 Study to Determine Progression-Free Survival and Evaluate Patient Experience for Patients With Metastatic ALK+ Non-Small Cell Lung Cancer (NSCLC) Treated With ALK Inhibitors.
Actual Study Start Date : July 23, 2018
Estimated Primary Completion Date : June 14, 2021
Estimated Study Completion Date : June 14, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ceritinib

Group/Cohort Intervention/treatment
Brigatinib
The dosage and regimen of brigatinib (ALK inhibitors) will be decided by participant's prescribing physician and will not be determined by participation in the study.
Drug: Brigatinib
Brigatinib tablets.

Alectinib
The dosage and regimen of alectinib (ALK inhibitors) will be decided by participant's prescribing physician and will not be determined by participation in the study.
Drug: Alectinib
Alectinib capsules.

Ceritinib
The dosage and regimen of ceritinib (ALK inhibitors) will be decided by participant's prescribing physician and will not be determined by participation in the study
Drug: Ceritinib
Ceritinib capsules.

Other ALK inhibitors
The dosage, regimen and the new ALK inhibitors will be decided by participant's prescribing physician and will not be determined by participation in the study.
Drug: Other ALK inhibitors
Other new ALK inhibitors available for treatment.




Primary Outcome Measures :
  1. Progression-free Survival [ Time Frame: Baseline up to disease progression or death due to any cause, whichever comes first (approximately 18 months) ]
    Progression-free survival (PFS) is defined as the time from the date of the first administration of ALK inhibitor to the date of the first documentation of disease progression or death due to any cause, whichever comes first, censored at the last date at which the participant was determined to be progression-free.


Secondary Outcome Measures :
  1. Quality of Life Status Using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire -Lung Cancer (EORTC QLQ-LC13) [ Time Frame: Baseline up to treatment cessation or up to approximately 18 months ]
    EORTC QLQ-LC13 contains 13 questions to assess for: dyspnea, and a series of single items including pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. Score of each item will range from 0 to 100, where 0 indicates no symptoms and 100 indicates worst possible symptoms.

  2. Daily Function Status by M.D. Anderson Symptom Inventory - Lung Cancer (MDASI-LC) [ Time Frame: Baseline up to treatment cessation or up to approximately 18 months ]
    The MDASI-LC Module includes 22 questions to assess the severity of multiple lung cancer-related symptoms and the impact of these symptoms on daily functioning. Symptom assessments include: pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, numbness/tingling, coughing, constipation, sore throat, general activity, mood, work, relations with others, walking, and enjoyment of life. Scores for each item range from 0 to 10, where 0 indicates no symptoms and 10 indicates worst possible symptoms.

  3. General Condition Status Using EuroQol Research Foundation EQ-5D-5L [ Time Frame: Baseline up to treatment cessation or up to approximately 18 months ]
    The EQ-5D-5L is a standardized non-disease-specific instrument for use as a measure of generic health status. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression.

  4. Treatment Satisfaction Using the Treatment Satisfaction Questionnaire for Medication (TSQM-9) [ Time Frame: Baseline up to treatment cessation or up to approximately 18 months ]
    The TSQM-9 contains 9 items assessing the following 3 domains: effectiveness (3 items), convenience (3 items) and global satisfaction (3 items).



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants diagnosed with ALK+NSCLC and who have been prescribed an ALK inhibitor.
Criteria

Inclusion Criteria:

  1. Has ALK+ NSCLC.
  2. Has been prescribed an ALK inhibitor.
  3. Has internet access.
  4. Is willing to answer regular e-surveys and allow for the prescriber or clinic to provide data on the status of the participant's NSCLC.

Exclusion Criteria:

  1. Has received any investigational compound within 90 days prior to consent.
  2. Has participated in an interventional clinical study within 90 days prior to consent. Non-interventional trials (that is observational trials) are permitted at any time point.

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): NCT03546894


Contacts
Layout table for location contacts
Contact: Takeda Study Registration Call Center +1-866-835-2233 globaloncologymedinfo@takeda.com

Locations
Layout table for location information
United States, Massachusetts
EmpiraMed, Inc. Recruiting
Maynard, Massachusetts, United States, 01754
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Layout table for investigator information
Study Director: Medical Director Millennium Pharmaceuticals, Inc.

Layout table for additonal information
Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03546894     History of Changes
Other Study ID Numbers: NSCLC-4001
U1111-1213-1757 ( Other Identifier: World Health Organization )
First Posted: June 5, 2018    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Takeda ( Millennium Pharmaceuticals, Inc. ):
Drug therapy

Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Ceritinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action