Lorlatinib-fortsættelsesundersøgelse
LORLATINIB (PF-06463922) FORTSÆTTELSESPROTOKOL: EN ÅBEN LABEL, EN-ARMET FORTSÆTTELSESUNDERSØGELSE FOR DELTAGERE MED ALK-POSITIV ELLER ROS1-POSITIV IKKE-SMÅCELLET LUNGECANCER (NSCLC), SOM FORTSÆTTER SPUDINICAL, DER FORTSÆTTER FLATINICAL.
The purpose of this protocol is to provide continued treatment access and safety follow-up for eligible participants who continue to derive a benefit from study intervention in the Pfizer sponsored lorlatinib parent studies that will be closed. Additional follow-up safety data collection will permit further characterization of the safety profile of lorlatinib in participants continuing to receive study intervention
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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California
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Irvine, California, Forenede Stater, 92612
- Chao Family Comprehensive Cancer Center and Ambulatory Care
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Rennes, Frankrig, 35033
- CHU de Rennes - Hôpital Pontchaillou
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Villejuif, Frankrig, 94805
- Institut Gustave Roussy
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Karnataka
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Bengaluru, Karnataka, Indien, 560027
- Healthcare Global Enterprises
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Maharashtra
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Thane, Maharashtra, Indien, 401107
- Bhaktivedanta Hospital & Research Institute
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 464-8681
- Aichi Cancer Center Hospital
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Shanghai, Kina, 200032
- Fudan University Shanghai Cancer Center
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Anhui
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Hefei, Anhui, Kina, 230022
- The First affiliated Hospital of Anhui Medical University
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100142
- Beijing Cancer Hospital
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Beijing, Beijing Municipality, Kina, 100000
- Beijing Chest Hospital, Capital Medical University
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Fujian
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Fuzhou, Fujian, Kina, 350014
- Fujian Cancer Hospital
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Guangdong
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Guangzhou, Guangdong, Kina, 510080
- Guangdong Provincial People's Hospital
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Hunan
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Changsha, Hunan, Kina, 410013
- Hunan Provincial Tumor Hospital
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Jiangsu
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Nanjing, Jiangsu, Kina, 210002
- General Hospital of Eastern Theater Command
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Jilin
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Changchun, Jilin, Kina, 130000
- Jilin Cancer Hospital
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Changchun, Jilin, Kina, 130021
- The first hospital of jilin university
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Qiantang District
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Hangzhou, Qiantang District, Kina, 310016
- Sir Run Shaw Hospital
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Shaanxi
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Xi'an, Shaanxi, Kina, 710038
- The Second Affiliated Hospital of PLA Air Force Medical University
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200030
- Shanghai Chest Hospital
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Sichuan
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Chengdu, Sichuan, Kina, 610041
- Sichuan Cancer hospital
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310022
- Zhejiang Cancer Hospital
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Hangzhou, Zhejiang, Kina, 310003
- The First Affiliated Hospital Zhejiang University School of Medicine
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Hangzhou, Zhejiang, Kina, 310052
- The Second Affiliated Hospital of Zhejiang University College of Medicine
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Singapore, Singapore, 119074
- National University Hospital
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Singapore, Singapore, 168583
- National Cancer Centre Singapore
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BARCELONA
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Barcelona, BARCELONA, Spanien, 08035
- Hospital Universitari Vall d'Hebron
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Taipei, Taiwan, 10002
- National Taiwan University Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
1 - Any participant who is receiving study treatment and deriving clinical benefit (as determined by the Principal Investigator) in a Pfizer-sponsored Lorlatinib Parent Study.
2- Participants must agree to follow the reproductive criteria. 3- Adequate Bone Marrow, Liver, Renal, Pancreatic Function
Exclusion Criteria:
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Lorlatinib
Lorlatinib single agent, 100 mg (4 x 25 mg) oral tables, QD, continuously |
ALK-positive NSCL treatment
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of participants with adverse events leading to permanent discontinuation of study intervention
Tidsramme: Baseline up to approximately 5 years
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Safety collection in this study will permit further characterization of the safety profile of lorlatinib |
Baseline up to approximately 5 years
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Number of serious adverse events reported for all participants
Tidsramme: Baseline up to approximately 5 years
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Safety collection in this study will permit further characterization of the safety profile of lorlatinib |
Baseline up to approximately 5 years
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Pfizer CT.gov Call Center, Pfizer
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- B7461039
- 2023-508952-21-00 (Registry Identifier: CTIS (EU))
- 2023 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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