Description of Clinical Anatomical Features and Long Term Follow-up for Patients With ALK Rearrangements

Non-small Cell Lung Cancer Clinical Trial

— CLINALK  

Official title:

Description of Clinical Anatomical Features and Long Term Follow-up for Patients With ALK Rearrangements

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02727335
• Other study ID #: IFCT-1302
• Status: Completed
• Start date: May 2014
• Est. completion date: December 2015

Study information

• Verified date: May 2023
• Source: Intergroupe Francophone de Cancerologie Thoracique
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Description of clinical and anatomical features and long-term follow-up for patients with ALK rearrangement and treated by crizotinib

Description:

Several French studies on crizotinib have been conducted in recent years. These are not only patients treated in the PROFILE 1005 and 1007 clinical studies but also patients who have been treated with crizotinib in the named patient ATU followed by the cohort ATU (Expended Access Cohort). Under the ATU program and according to ATU regulations, a limited set of data is collected and furthermore the follow up is stopped as soon as the ATU program closes. Thus it is not possible to have access to long term data and post progression data. Our project is to collect data from the patients from the ATU program (named patient and cohort) and if possible patients treated after the marketing of crizotinib, before, during and after crizotinib therapy. Centers selected for this observational study will be those of the IFCT network that took part in the ATU program. This will allow an accurate analysis of crizotinib therapy under "real life" conditions. It should be emphasized that this information is generally neither available from clinical trials nor from ATU programs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient must have locally advanced or metastatic NSCLC (Stage IIIb or Stage IV by AJCC 7th.) with positive ALK determined by IHC and/or FISH.
• Patient who received crizotinib on an expanded access basis (compassionate use) (ATU) due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable
• Patient who received marketed crizotinib as a result of the standard care of metastatic NSCLC (Stage IIIb or Stage IV by AJCC 7th.) with positive ALK will also be eligible.
• Patient was able to swallow capsules and had no surgical or anatomical condition that precluded the patient from swallowing and absorbing oral medications on an ongoing basis.
• Patient has taken at least 1 week of treatment

Exclusion Criteria:

• Patient included in a crizotinib clinical trial
• Patient with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.

Related Conditions & MeSH terms

• Anaplastic Lymphoma Kinase Gene Mutation
• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Locations

Country	Name	City	State
France	Agen - CH	Agen
France	Angers - CHU	Angers
France	Angoulême - CH	Angoulême
France	Annecy - CH	Annecy
France	Avignon - Institut Sainte-Catherine	Avignon
France	CHU Besancon - Pneumologie	Besancon
France	Bordeaux - Clinique Saint Augustin	Bordeaux
France	Boulogne - Hôpital Ambroise Paré	Boulogne
France	Brest - Hôpital du Morvan	Brest
France	CH de Cannes	Cannes
France	CH Chambery	Chambery
France	Clermont-Ferrand - Centre Jean Perrin	Clermont-Ferrand
France	Clermont-Ferrand - CHU	Clermont-Ferrand
France	Colmar - CH	Colmar
France	CH de Dax	Dax
France	Dijon - CHU	Dijon
France	Dole - Centre Hospitalier Louis Pasteur	Dole
France	Douai - CH	Douai
France	Fréjus - CHI Saint Raphaël	Fréjus
France	CHRU Grenoble	Grenoble
France	Grenoble - Institut Daniel Hollard	Grenoble
France	Centre Hospitalier - Pneumologie	Le Havre
France	Centre Hospitalier - Pneumologie	Le Mans
France	Libourne - CH	Libourne
France	Centre Oscar Lambret	Lille
France	Limoges - Hôpital du Cluzeau	Limoges
France	Longjumeau - CH	Longjumeau
France	Mâcon - CH	Mâcon
France	Marseille - CRLCC	Marseille
France	Marseille - Hôpital Saint Joseph	Marseille
France	Polyclinique du Parc	Maubeuge
France	Meaux - CH	Meaux
France	Meulan - CHI	Meulan-en-Yvelines
France	CH de Mulhouse	Mulhouse
France	Centre Antoine Lacassagne	Nice
France	Hopital Tenon - Pneumologie	Paris
France	Paris - Curie	Paris
France	Paris - Hôpital Cochin	Paris
France	Paris - Hôpital Européen Georges Pompidou	Paris
France	Paris - Hôpital Saint Joseph	Paris
France	Pau - CH	Pau
France	Lyon Sud	Pierre Bénite
France	CHU	Poitiers
France	Reims - Institut Courlancy	Reims
France	Rennes - Clinique Saint Laurent	Rennes
France	Rodez - CH	Rodez
France	Rouen - CHU	Rouen
France	Saint Herblain - Institut de Cancérologie de l'Ouest - René Gauducheau	Saint Herblain
France	Saint Priest en Jarez - ICL	Saint Priest en Jarez
France	Saint Denis de la Réunion - CHD Guyon	Saint-Denis
France	Saint-Julien-en-Genvois - CHI	Saint-Julien-en-Genevois
France	Strasbourg - Centre Paul Strauss	Strasbourg
France	Strasbourg - NHC	Strasbourg
France	Suresnes - Hopital Foch	Suresnes
France	Centre Hospitalier Intercommunal	Toulon
France	Toulouse - CHU Larrey	Toulouse
France	Toulouse - Clinique Pasteur	Toulouse
France	Tours - CHU	Tours
France	Troyes - CH	Troyes
France	Vannes - Centre Hospitalier Bretagne Atlantique	Vannes
France	Vénissieux - Groupe Hospitalier Mutualiste les Portes du Sud	Vénissieux
France	CH de Villefranche - Pneumologie	Villefranche
France	Villejuif - Institut Gustave Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Intergroupe Francophone de Cancerologie Thoracique

Country where clinical trial is conducted

France, 

References & Publications (1)

Duruisseaux M, Besse B, Cadranel J, Perol M, Mennecier B, Bigay-Game L, Descourt R, Dansin E, Audigier-Valette C, Moreau L, Hureaux J, Veillon R, Otto J, Madroszyk-Flandin A, Cortot A, Guichard F, Boudou-Rouquette P, Langlais A, Missy P, Morin F, Moro-Sib — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	overall survival post-progression on crizotinib	5 years
Secondary	rare and severe complications of crizotinib therapy	Incidence of rare and severe complications of crizotinib therapy: hepatotoxicity, interstitial pneumonitis, diastolic heart failure	5 years

External Links

•   Official website