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Crizotinib Continuation Clinical Study

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: NCT05160922
Recruitment Status : Recruiting
First Posted : December 16, 2021
Last Update Posted : June 5, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
The purpose of this continuation study is to provide continued access to crizotinib treatment for eligible participants from a current Pfizer sponsored crizotinib clinical study that is planned to close.

Condition or disease Intervention/treatment Phase
NSCLC ALCL IMT Drug: crizotinib Phase 4

Detailed Description:
Participants not previously enrolled or who have discontinued study treatment or safety follow-up in a current Pfizer sponsored crizotinib clinical study are not eligible for participation in this continuation study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CRIZOTINIB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED CRIZOTINIB CLINICAL STUDIES
Actual Study Start Date : December 27, 2021
Estimated Primary Completion Date : December 26, 2026
Estimated Study Completion Date : December 26, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Crizotinib

Arms and Interventions
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Arm Intervention/treatment
crizotinib
crizotinib oral treatment
 Drug: crizotinib
crizotinib oral treatment
Other Name: XALKORI


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events leading to permanent discontinuation of study intervention [ Time Frame: Baseline up to approximately 5 years ]
    Safety data collection in this study will permit further characterization of the safety profile of crizotinib.

  2. Number of serious adverse events reported for all participants [ Time Frame: Baseline up to approximately 5 years ]
    Safety data collection in this study will permit further characterization of the safety profile of crizotinib.


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:   1 Year to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Participants must meet the following key inclusion criteria to be eligible for enrollment into the study:

  1. Any participant who is receiving crizotinib and deriving clinical benefit (as determined by their doctor) in a Crizotinib Study which is planned to close.
  2. Participants must agree to follow the reproductive criteria as outlined in protocol.
  3. No ongoing Grade ≥3 or intolerable Grade 2 AEs considered to be related to crizotinib treatment, except for those laboratory eligibility criteria described in Inclusion #4.
  4. Adult Participants (≥18 years): Adequate hepatic and bone marrow function. Stable renal function for at least 14 days.

Pediatric Participants (<18 years): Adequate hepatic and bone marrow function. Stable renal function for at least 14 days.

Exclusion Criteria

Participants with any of the following characteristics/conditions will be excluded:

  1. Female participants who are pregnant or breastfeeding.
  2. Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.
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): NCT05160922


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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China, Beijing
Beijing Cancer Hospital Active, not recruiting
Beijing, Beijing, China, 100142
China, Fujian
Fujian Province Oncology Hospital Recruiting
Fuzhou, Fujian, China, 350014
China, Jilin
Jilin Cancer Hospital Not yet recruiting
Changchun, Jilin, China, 130028
China
Shanghai Chest Hospital Recruiting
Shanghai, China, 200030
Italy
ASST Monza Recruiting
Monza, MB, Italy, 20900
Japan
National Hospital Organization Nagoya Medical Center Active, not recruiting
Nagoya, Aichi, Japan, 460-0001
Russian Federation
Limited Liability Company "EuroCityClinic" Recruiting
Saint-Petersburg, Russian Federation, 197022
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05160922    
Other Study ID Numbers: A8081075
First Posted: December 16, 2021    Key Record Dates
Last Update Posted: June 5, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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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 Pfizer:
crizotinib
Xalkori
Anaplastic Lymphoma Kinase
ALK
ROS1
NSCLC
 Non-small Cell Lung Cancer
ALCL
anaplastic large cell lymphoma
IMT
inflammatory myofibroblastic tumour
Additional relevant MeSH terms:
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Crizotinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action