Lorlatinib fortsettelsesstudie
LORLATINIB (PF-06463922) FORTSATT PROTOKOL: EN ÅPEN ETIKETTE, ENARMET FORTSATT STUDIE FOR DELTAKERE MED ALK-POSITIV ELLER ROS1-POSITIV IKKE-SMÅCELLET LUNGEKANCER (NSCLC) SOM FORTSATT FLOATTONBALLO STOKKRETT
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
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California
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Irvine, California, Forente stater, 92612
- Chao Family Comprehensive Cancer Center and Ambulatory Care
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Rennes, Frankrike, 35033
- CHU de Rennes - Hôpital Pontchaillou
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Villejuif, Frankrike, 94805
- Institut Gustave Roussy
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Karnataka
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Bengaluru, Karnataka, India, 560027
- Healthcare Global Enterprises
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Maharashtra
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Thane, Maharashtra, India, 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, Spania, 08035
- Hospital Universitari Vall d'Hebron
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Taipei, Taiwan, 10002
- National Taiwan University Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Lorlatinib
Lorlatinib single agent, 100 mg (4 x 25 mg) oral tables, QD, continuously |
ALK-positive NSCL treatment
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Safety collection in this study will permit further characterization of the safety profile of lorlatinib |
Baseline up to approximately 5 years
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Pfizer CT.gov Call Center, Pfizer
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- B7461039
- 2023-508952-21-00 (Registeridentifikator: CTIS (EU))
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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