Clinical trial NCT03763604: Named Patient Use Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer
Official title: Named Patient Use Program to Provide Abemaciclib for the Treatment of Metastatic Breast Cancer
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Metastatic Breast Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-12-04
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.


Eligibility criteria: Inclusion Criteria:

* Patients with hormone receptor positive metastatic breast cancer for whom there is reasonable expectation that abemaciclib may provide clinical benefit and who are suitable to receive abemaciclib.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: North Tamworth
country: Australia
facility: North West Cancer Centre
state: New South Wales
city: Sydney
country: Australia
facility: St Vincent's Hospital Sydney
state: New South Wales
city: Sydney
country: Australia
facility: Mater Hospital Sydney
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Wollongong
country: Australia
facility: Wollongong Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Elizabeth Vale
country: Australia
facility: Adelaide Oncology and Haematology, Calvary Central Districts Hospital
state: South Australia
city: Hobart
country: Australia
facility: Icon Cancer Centre - Hobart
state: Tasmania
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Box Hill
country: Australia
facility: Box Hill Hospital Outpatients
state: Victoria
city: Box Hill
country: Australia
facility: Epworth Eastern Hospital
state: Victoria
city: Brighton
country: Australia
facility: Melbourne Cancer Care
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
city: Richmond
country: Australia
facility: Dr. Zimet Private Room
state: Victoria
city: Richmond
country: Australia
facility: Slade Pharmacy Epworth Hospital
state: Victoria
city: Shepparton
country: Australia
facility: Goulburn Valley Health
state: Victoria
city: Auchenflower
country: Australia
facility: Icon Cancer Care - The Wesley Medical Centre
city: Freches Forest
country: Australia
facility: Northern Beaches Hospital
city: Victor Harbor
country: Australia
facility: South Coast District Hospital
city: Calgary
country: Canada
facility: Tom Baker Cancer Center
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Vancouver
country: Canada
facility: BC Cancer Vancouver
state: British Columbia
city: Victoria
country: Canada
facility: British Columbia Cancer Agency - Vancouver Island
state: British Columbia
city: Kitchener
country: Canada
facility: Grand River Regional Cancer Centre
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Sault Ste. Marie
country: Canada
facility: Algoma District Cancer Program
state: Ontario
city: Toronto
country: Canada
facility: Unity Health Toronto, St. Michael's Hospital
state: Ontario
city: Québec City
country: Canada
facility: CHUL du CHU de Québec
state: Quebec
city: Regina
country: Canada
facility: Allan Blair Cancer Centre
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Centre
state: Saskatchewan
city: Mohandeseen
country: Egypt
facility: Cairo Oncology Center (Cairo Cure)
state: Cairo
city: Teynampet
country: India
facility: Apollo Cancer Institute, Apollo Speciality Hospital
state: Chennai
city: New Delhi
country: India
facility: Indraprastha Apollo Hospital
city: Torre
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata
state: Roma
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IRCCS
state: Veneto
city: Varese
country: Italy
facility: Ospedale Di Circolo E Fondazione Macchi
city: Ilsandong-gu
country: Korea, Republic of
facility: National Cancer Center
state: Goyang-si Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
state: Incheon-gwangyeoksi [Incheon]
city: Gyeonggi-do
country: Korea, Republic of
facility: St. Mary's Hospital
state: Korea
city: Namdong-gu, Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Korea
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
state: Korea
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Kyǒnggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul, Korea
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Ewha University Mokdong Hospital
state: Yangcheon-gu
city: Chungcheongbuk-do
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Center Chilgok Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Sungai Petani
country: Malaysia
facility: Pantai Hospital Sungai Petani
state: Kedah
city: Georgetown
country: Malaysia
facility: Gleneagles Penang
state: Penang
city: Georgetown
country: Malaysia
facility: Penang Adventist Hospital
state: Penang
city: Tanjung Bungah
country: Malaysia
facility: Mount Miriam Cancer Hospital
state: Penang
city: Off Jalan Templer
country: Malaysia
facility: Beacon Hospital
state: Petaling JAYA
city: Bayan BARU
country: Malaysia
facility: Pantai Hospital Penang
state: Pulau Pinang
city: Georgetown
country: Malaysia
facility: Loh Guan Lye Specialists' Centre
state: Pulau Pinang
city: Kuching
country: Malaysia
facility: Hospital Umum Sarawak
state: Sarawak
city: Petaling Jaya
country: Malaysia
facility: Subang Jaya Medical Centre
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: Pantai Hospital Kuala Lumpur
state: Wilayah Persekutuan
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
city: Kuala Lumpur
country: Malaysia
facility: Universiti Malaya Medical Centre
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
city: Putrajaya
country: Malaysia
facility: Institut Kanser Negara
city: Singapore
country: Singapore
facility: Elizabeth Au Oncology
city: Pinelands
country: South Africa
facility: Vincent Pallotti Hospital
state: Cape Town
city: Floracliff
country: South Africa
facility: Flora Clinic
state: Gauteng
city: Johannesburg
country: South Africa
facility: Olivedale Clinic
state: Gauteng
city: Johannesburg
country: South Africa
facility: Netcare Linksfield Hospital
state: Gauteng
city: Johannesburg
country: South Africa
facility: Donald Gordon Medical Center
state: Gauteng
city: Johannesburg
country: South Africa
facility: Wits Donald Gordon Clinical Trial Center
state: Gauteng
city: Johannesburg
country: South Africa
facility: The Medical Oncology Centre of Rosebank
state: Gauteng
city: Morningside
country: South Africa
facility: Sandton Oncology
state: Gauteng
city: Parktown
country: South Africa
facility: DGMC Oncology
state: Gauteng
city: Durban
country: South Africa
facility: Amanzimtoti Oncology Centre
state: KwaZulu-Natal
city: Hilton
country: South Africa
facility: Hopelands Cancer Centre Hilton
state: KZN
city: Richards Bay
country: South Africa
facility: Abraham Oncology
state: KZN
city: George
country: South Africa
facility: Cancercare
state: Western Cape
city: Amanzimtoti
country: South Africa
facility: Dr Pirjol and Szpak Inc. Oncology Pratice
city: Cape Town
country: South Africa
facility: Cancercare Rondebosch Oncology
city: Alcoy
country: Spain
facility: Hospital Virgen de los Lirios
state: Alicante
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
state: Andalucía
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
state: Barcelona [Barcelona]
city: Sant Cugat del Vallès
country: Spain
facility: Hospital Universitari General de Catalunya
state: Barcelona [Barcelona]
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr. Josep Trueta
state: Barcelona
city: Hospitalet De Llobregat
country: Spain
facility: Hospital Duran I Reynals
state: Barcelona
city: L'Hospitalet de Llobregat
country: Spain
facility: Institut Catala d'Oncologia
state: Barcelona
city: Sabadell
country: Spain
facility: Corporacion Sanitaria Parc Tauli
state: Barcelona
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Catalunya [Cataluña]
city: Tenerife
country: Spain
facility: Hospital Universitario de Canarias
state: La Laguna
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
state: Madrid, Comunidad De
city: Aravaca
country: Spain
facility: Hospital la Zarzuela
state: Madrid
city: Mostoles
country: Spain
facility: Hospital De Mostoles
state: Madrid
city: El Palmar
country: Spain
facility: Hospital Universitario Virgen de la Arrixaca
state: Murcia
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Palma De Mallorca(Baleares)
city: Gandia
country: Spain
facility: H. San Francisco de Borja (H. GANDIA)
state: Valencia
city: Xativa
country: Spain
facility: Hospital Lluis Alcanyis
state: Valencia
city: Bilbao
country: Spain
facility: Hospital De Basurto
state: Vizcaya
city: Albacete
country: Spain
facility: Hospital General de Albacete
city: Barcelona
country: Spain
facility: Hospital Quironsalud Barcelona- END
city: Barcelona
country: Spain
facility: Hospital Quirón Salud Barcelona-Instituto Oncológico Baselga
city: Barcelona
country: Spain
facility: Hospital Universitari Dexeusa
city: Barcelona
country: Spain
facility: Instituto Oncologico Dr Rosell (IOR)
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Coruña
country: Spain
facility: Hospital Arquitecto Marcide (Área Sanitaria de Ferrol)
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
city: Madrid
country: Spain
facility: Cl. Universitaria Navarra
city: Madrid
country: Spain
facility: Centro Oncológico MD Anderson
city: Madrid
country: Spain
facility: Hospital Ruber Internacional
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Madrid Norte Sanchinarro
city: Madrid
country: Spain
facility: Hospital Infanta Cristina
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
city: Valencia
country: Spain
facility: Fundación Instituto Valenciano de Oncología
city: Valencia
country: Spain
facility: Hospital Clinico Universitario Valencia
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova Valencia
city: Valencia
country: Spain
facility: Hospital Doctor Peset
city: Valencia
country: Spain
facility: Hospital de Sagunto
city: Zaragoza
country: Spain
facility: IDCQ HOSPITALES Y SANIDAD, S.L.U. (Hospital Quirón Zaragoza)
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Zaragoza
country: Spain
facility: Hospital Universitario Zaragoza
city: Basel
country: Switzerland
facility: Universitätsspital Basel
state: Basel Stadt
city: Meyrin
country: Switzerland
facility: Hôpital de la Tour, La Tour Hôpital Privé SA
state: Geneva
city: Rapperswil
country: Switzerland
facility: Tumorzentrum ZeTuP Rapperswil-Jona
state: Saint Gallen
city: St. Gallen
country: Switzerland
facility: Tumor- und Brustzentrum ZeTuP Sankt Gallen
state: Saint Gallen
city: st.Gallen
country: Switzerland
facility: Cantonal Hospital St.Gallen
state: Sankt Gallen
city: Lugano
country: Switzerland
facility: Oncologia Varini Calderoni Christinat
state: Ticino
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: Genève
country: Switzerland
facility: HUG-Hôpitaux Universitaires de Genève
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital
city: Zürich
country: Switzerland
facility: OnkoZentrum Zürich AG
city: Putzu City
country: Taiwan
facility: Chiayi Chang Gung Memorial Hospital
state: Chiayi County
city: Niaosong Dist
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
state: Kaohsiung City
city: Taipei City
country: Taiwan
facility: Tri-Service General Hospital
state: Taipei
city: Zhongzheng District
country: Taiwan
facility: National Taiwan University Hospital Yunlin Branch
state: Taipei
city: New Taipei City
country: Taiwan
facility: MacKay Memorial Hospital
state: Tamsui District
city: Taichung
country: Taiwan
facility: Taichung Tzu Chi Hospital
state: Tanzi District
city: Taoyuan
country: Taiwan
facility: Saint Paul's Hospital
state: Taoyuan District
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Municipal Siaogang Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yan-Sen Cancer Center
city: Yunlin County, Douliu City
country: Taiwan
facility: National Taiwan University Hospital Yunlin Branch
city: Muang Chiangmai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
state: Chiangmai
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
state: Ratchathewi District
city: Hat Yai
country: Thailand
facility: Songklanagarind Hospital
state: Songkhla
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memoiral Hospsital
city: Bangkok
country: Thailand
facility: Ramathibodi Hopsital
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
state: Cambridgeshire
city: Radlett
country: United Kingdom
facility: Loom Dene
state: Hertfordshire
city: Newcastle Upon Tyne
country: United Kingdom
facility: Northern Centre for Cancer Treatment
state: Tyne And Wear
Study officials:
References: