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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03763604




Registration number
NCT03763604
Ethics application status
Date submitted
3/12/2018
Date registered
4/12/2018
Date last updated
12/10/2023

Titles & IDs
Public title
Named Patient Use Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer
Scientific title
Named Patient Use Program to Provide Abemaciclib for the Treatment of Metastatic Breast Cancer
Secondary ID [1] 0 0
I3Y-MC-Y001
Secondary ID [2] 0 0
17088
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Expanded Access
Description of intervention(s) / exposure
Treatment: Drugs - Abemaciclib

Treatment: Drugs: Abemaciclib
Administered orally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Key exclusion criteria

Study design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Available
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,VIC
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
North West Cancer Centre - North Tamworth
Recruitment hospital [3] 0 0
St Vincent's Hospital Sydney - Sydney
Recruitment hospital [4] 0 0
Mater Hospital Sydney - Sydney
Recruitment hospital [5] 0 0
Westmead Hospital - Westmead
Recruitment hospital [6] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [7] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [8] 0 0
Adelaide Oncology and Haematology, Calvary Central Districts Hospital - Elizabeth Vale
Recruitment hospital [9] 0 0
Icon Cancer Centre - Hobart - Hobart
Recruitment hospital [10] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [11] 0 0
Box Hill Hospital Outpatients - Box Hill
Recruitment hospital [12] 0 0
Epworth Eastern Hospital - Box Hill
Recruitment hospital [13] 0 0
Melbourne Cancer Care - Brighton
Recruitment hospital [14] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [15] 0 0
Dr. Zimet Private Room - Richmond
Recruitment hospital [16] 0 0
Slade Pharmacy Epworth Hospital - Richmond
Recruitment hospital [17] 0 0
Goulburn Valley Health - Shepparton
Recruitment hospital [18] 0 0
Icon Cancer Care - The Wesley Medical Centre - Auchenflower
Recruitment hospital [19] 0 0
Northern Beaches Hospital - Freches Forest
Recruitment hospital [20] 0 0
South Coast District Hospital - Victor Harbor
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2340 - North Tamworth
Recruitment postcode(s) [3] 0 0
2010 - Sydney
Recruitment postcode(s) [4] 0 0
2060 - Sydney
Recruitment postcode(s) [5] 0 0
2145 - Westmead
Recruitment postcode(s) [6] 0 0
2500 - Wollongong
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [9] 0 0
7000 - Hobart
Recruitment postcode(s) [10] 0 0
7001 - Hobart
Recruitment postcode(s) [11] 0 0
3128 - Box Hill
Recruitment postcode(s) [12] 0 0
3186 - Brighton
Recruitment postcode(s) [13] 0 0
3000 - Melbourne
Recruitment postcode(s) [14] 0 0
3121 - Richmond
Recruitment postcode(s) [15] 0 0
3630 - Shepparton
Recruitment postcode(s) [16] 0 0
4066 - Auchenflower
Recruitment postcode(s) [17] 0 0
2086 - Freches Forest
Recruitment postcode(s) [18] 0 0
5211 - Victor Harbor
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
Canada
State/province [5] 0 0
Saskatchewan
Country [6] 0 0
Egypt
State/province [6] 0 0
Cairo
Country [7] 0 0
India
State/province [7] 0 0
Chennai
Country [8] 0 0
India
State/province [8] 0 0
New Delhi
Country [9] 0 0
Italy
State/province [9] 0 0
Roma
Country [10] 0 0
Italy
State/province [10] 0 0
Veneto
Country [11] 0 0
Italy
State/province [11] 0 0
Varese
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Goyang-si Gyeonggi-do
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Gyeonggi-do
Country [14] 0 0
Korea, Republic of
State/province [14] 0 0
Incheon-gwangyeoksi [Incheon]
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Korea
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Kyonggi-do
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Seoul, Korea
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Seoul-teukbyeolsi [Seoul]
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Yangcheon-gu
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Chungcheongbuk-do
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Daegu
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Seoul
Country [23] 0 0
Malaysia
State/province [23] 0 0
Kedah
Country [24] 0 0
Malaysia
State/province [24] 0 0
Penang
Country [25] 0 0
Malaysia
State/province [25] 0 0
Petaling JAYA
Country [26] 0 0
Malaysia
State/province [26] 0 0
Pulau Pinang
Country [27] 0 0
Malaysia
State/province [27] 0 0
Sarawak
Country [28] 0 0
Malaysia
State/province [28] 0 0
Selangor
Country [29] 0 0
Malaysia
State/province [29] 0 0
Wilayah Persekutuan
Country [30] 0 0
Malaysia
State/province [30] 0 0
Kuala Lumpur
Country [31] 0 0
Malaysia
State/province [31] 0 0
Putrajaya
Country [32] 0 0
Singapore
State/province [32] 0 0
Singapore
Country [33] 0 0
South Africa
State/province [33] 0 0
Cape Town
Country [34] 0 0
South Africa
State/province [34] 0 0
Gauteng
Country [35] 0 0
South Africa
State/province [35] 0 0
KwaZulu-Natal
Country [36] 0 0
South Africa
State/province [36] 0 0
KZN
Country [37] 0 0
South Africa
State/province [37] 0 0
Western Cape
Country [38] 0 0
South Africa
State/province [38] 0 0
Amanzimtoti
Country [39] 0 0
Spain
State/province [39] 0 0
Alicante
Country [40] 0 0
Spain
State/province [40] 0 0
Andalucía
Country [41] 0 0
Spain
State/province [41] 0 0
Barcelona [Barcelona]
Country [42] 0 0
Spain
State/province [42] 0 0
Barcelona
Country [43] 0 0
Spain
State/province [43] 0 0
Catalunya [Cataluña]
Country [44] 0 0
Spain
State/province [44] 0 0
La Laguna
Country [45] 0 0
Spain
State/province [45] 0 0
Madrid, Comunidad De
Country [46] 0 0
Spain
State/province [46] 0 0
Madrid
Country [47] 0 0
Spain
State/province [47] 0 0
Murcia
Country [48] 0 0
Spain
State/province [48] 0 0
Palma De Mallorca(Baleares)
Country [49] 0 0
Spain
State/province [49] 0 0
Valencia
Country [50] 0 0
Spain
State/province [50] 0 0
Vizcaya
Country [51] 0 0
Spain
State/province [51] 0 0
Albacete
Country [52] 0 0
Spain
State/province [52] 0 0
Coruña
Country [53] 0 0
Spain
State/province [53] 0 0
Granada
Country [54] 0 0
Spain
State/province [54] 0 0
Salamanca
Country [55] 0 0
Spain
State/province [55] 0 0
Zaragoza
Country [56] 0 0
Switzerland
State/province [56] 0 0
Basel Stadt
Country [57] 0 0
Switzerland
State/province [57] 0 0
Geneva
Country [58] 0 0
Switzerland
State/province [58] 0 0
Saint Gallen
Country [59] 0 0
Switzerland
State/province [59] 0 0
Sankt Gallen
Country [60] 0 0
Switzerland
State/province [60] 0 0
Ticino
Country [61] 0 0
Switzerland
State/province [61] 0 0
Genève
Country [62] 0 0
Switzerland
State/province [62] 0 0
Luzern
Country [63] 0 0
Switzerland
State/province [63] 0 0
Zürich
Country [64] 0 0
Taiwan
State/province [64] 0 0
Chiayi County
Country [65] 0 0
Taiwan
State/province [65] 0 0
Kaohsiung City
Country [66] 0 0
Taiwan
State/province [66] 0 0
Taipei
Country [67] 0 0
Taiwan
State/province [67] 0 0
Tamsui District
Country [68] 0 0
Taiwan
State/province [68] 0 0
Tanzi District
Country [69] 0 0
Taiwan
State/province [69] 0 0
Taoyuan District
Country [70] 0 0
Taiwan
State/province [70] 0 0
Kaohsiung
Country [71] 0 0
Taiwan
State/province [71] 0 0
Taichung
Country [72] 0 0
Taiwan
State/province [72] 0 0
Taipei City
Country [73] 0 0
Taiwan
State/province [73] 0 0
Yunlin County, Douliu City
Country [74] 0 0
Thailand
State/province [74] 0 0
Chiangmai
Country [75] 0 0
Thailand
State/province [75] 0 0
Ratchathewi District
Country [76] 0 0
Thailand
State/province [76] 0 0
Songkhla
Country [77] 0 0
Thailand
State/province [77] 0 0
Bangkok
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Cambridgeshire
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Hertfordshire
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Tyne And Wear

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03763604
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03763604