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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05254743




Registration number
NCT05254743
Ethics application status
Date submitted
15/02/2022
Date registered
24/02/2022

Titles & IDs
Public title
A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Scientific title
A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314)
Secondary ID [1] 0 0
J2N-OX-JZNU
Secondary ID [2] 0 0
18281
Universal Trial Number (UTN)
Trial acronym
BRUIN-CLL-314
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia 0 0
Leukemia, Lymphocytic 0 0
Leukemia, B-cell 0 0
Small Lymphocytic Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Pirtobrutinib
Treatment: Drugs - Ibrutinib

Experimental: Pirtobrutinib - Administered orally.

Active comparator: Ibrutinib - Administered orally.


Treatment: Drugs: Pirtobrutinib
Administered orally.

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

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Complete Response (CR), Complete Remission with Incomplete Hematologic Recovery (Cri), Nodular Partial Remission (nPR) or Partial Response (PR): Overall Response Rate (ORR)
Timepoint [1] 0 0
Baseline to best overall response at or before the initiation of subsequent anti-cancer therapy (if any) (approximately 3 years and 5 months)
Secondary outcome [1] 0 0
Event-Free Survival (EFS)
Timepoint [1] 0 0
Randomization to first occurrence of treatment discontinuation due to adverse event/toxicity, treatment-emergent atrial fibrillation or atrial flutter of any grade, progressive disease (PD) or death (approximately 4 years)
Secondary outcome [2] 0 0
Progression-Free Survival (PFS)
Timepoint [2] 0 0
Randomization to PD (per iwCLL 2018 criteria) or death from any cause (approximately 5 years 8 months)
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
Time from the date of the first documented response of CR, CRi, nPR or PR to the earlier of documentation of definitive PD (per iwCLL 2018 criteria) or death from any cause (approximately 2 years)
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
Randomization to death from any cause (approximately 6 years)
Secondary outcome [5] 0 0
Time to Next Treatment (TTNT)
Timepoint [5] 0 0
Randomization to initiation of the next systemic anticancer therapy for CLL/SLL or death from any cause, whichever occurs first (approximately 6 years)
Secondary outcome [6] 0 0
Time to Worsening (TTW) of CLL/SLL Related Symptoms
Timepoint [6] 0 0
Randomization to time to worsening symptoms (approximately 6 years)

Eligibility
Key inclusion criteria
* Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
* Adequate organ function

* Platelets greater than or equal to = 50 x 10?/liter (L) or =30 x 10?/L in participants with documented bone marrow involvement considered to impair hematopoiesis,
* Hemoglobin =8 grams/deciliter (g/dL) or =6 g/dL in participants with documented bone marrow involvement considered to impair hematopoiesis
* Absolute neutrophil count =0.75 x 10?/L or =0.50 × 10?/L in participants with documented bone marrow involvement considered to impair hematopoiesis
* Kidney function: Estimated creatinine clearance =30 milliliters per minute (mL/min)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time preceding enrollment
* Known or suspected central nervous system (CNS) involvement
* A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disease
* Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])
* Significant cardiovascular disease including ejection fraction < 40% and any grade ongoing atrial fibrillation or atrial flutter
* Hepatitis B or hepatitis C testing indicating active/ongoing infection, based on Screening laboratory tests
* Active cytomegalovirus (CMV) infection
* Active uncontrolled systemic bacterial, viral, or fungal infection
* Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
* Clinically significant active malabsorption syndrome or other condition likely to affect GI absorption of the oral-administered study treatments
* Ongoing inflammatory bowel disease
* Prior exposure to BTK inhibitor (covalent or noncovalent)
* Concurrent use of investigational agent or anticancer therapy except hormonal therapy
* Participants requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
* Use of > 20 mg prednisone daily or equivalent dose of steroid at the time of first dose of study drug
* Vaccination with a live vaccine within 28 days prior to randomization
* Participants receiving chronic therapy with a strong cytochrome P450 (CYP)3A inhibitor (except posaconazole and voriconazole) which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment
* Participants with known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or ibrutinib

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2028
Actual
Sample size
Target
650
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Sunshine Hospital - St Albans
Recruitment hospital [2] 0 0
One Clinical Research - Nedlands
Recruitment hospital [3] 0 0
The Perth Blood Institute - West Perth
Recruitment postcode(s) [1] 0 0
3021 - St Albans
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment postcode(s) [3] 0 0
6005 - West Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
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United States of America
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California
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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Maryland
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United States of America
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Montana
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United States of America
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New York
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United States of America
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North Carolina
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Ohio
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Pennsylvania
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United States of America
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Rhode Island
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autónoma De Buenos Aire
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Santa Fe
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Austria
State/province [24] 0 0
Oberösterreich
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Austria
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Vienna
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Belgium
State/province [26] 0 0
Oost-Vlaanderen
Country [27] 0 0
Belgium
State/province [27] 0 0
West Flanders
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Belgium
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Leuven
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Brazil
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Paraná
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Brazil
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Rio Grande Do Sul
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Brazil
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Sao Paulo
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Brazil
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São Paulo
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Brazil
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Cascavel
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Canada
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Manitoba
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Canada
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Ontario
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Canada
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Québec
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Chile
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IX Región
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Chile
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Región Metropolitana
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Chile
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Santiago
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Chile
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Valparaíso
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China
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Anhui
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China
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Guangdong
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China
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Guangxi
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China
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Hubei
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China
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Hunan
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China
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Jiangxi
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China
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Shanghai
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China
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Tianjin
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China
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Xinjiang
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China
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Zhejiang
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China
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Haikou
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China
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Hangzhou
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China
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Wuhan
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Czechia
State/province [54] 0 0
Brno
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Czechia
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Hradec Kralove
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Czechia
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Ostrava-Poruba
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Czechia
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Plzen - Lochotin
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Czechia
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Praha 10
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Czechia
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Praha 2
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France
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Cedex 13
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France
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Cedex 1
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France
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Cedex 9
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France
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Cedex
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France
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Nice Cedex 2
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France
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Tours Cedex 9
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France
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La Roche sur Yon
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France
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Le Mans
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France
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Limoges
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France
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Rouen Cedex
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Germany
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Baden
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Germany
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Köln
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Germany
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Nordrhein Westfalen
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Germany
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Sachsen Anhalt
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Germany
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Sachsen
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Hungary
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Debrecen
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Hungary
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Szombathely
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Israel
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Jerusalem
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Israel
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Petach-Tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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Forlì-Cesena
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Italy
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Otago
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Italy
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Torino
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Italy
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Alessandria
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Italy
State/province [85] 0 0
Bologna
Country [86] 0 0
Italy
State/province [86] 0 0
Milano
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Italy
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Reggio Emilia
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Italy
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Verona
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Japan
State/province [89] 0 0
Kanagawa
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Japan
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Kumamoto
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Japan
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Yamagata
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Korea, Republic of
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Seoul, Korea
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Korea, Republic of
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Seoul
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Korea, Republic of
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Busan
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New Zealand
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Wellington
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New Zealand
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Dunedin
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New Zealand
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Hamilton
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New Zealand
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Otahuhu
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Poland
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Pomorskie
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Poland
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Poznan
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Poland
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Biala Podlaska
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Poland
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Bydgoszcz
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Poland
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Katowice
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Poland
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Krakow
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Poland
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Lublin
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Poland
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Opole
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Poland
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Wroclaw
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Spain
State/province [108] 0 0
Cataluna
Country [109] 0 0
Spain
State/province [109] 0 0
Catalunya [Cataluña]
Country [110] 0 0
Spain
State/province [110] 0 0
Cataluña
Country [111] 0 0
Spain
State/province [111] 0 0
Madrid, Comunidad De
Country [112] 0 0
Spain
State/province [112] 0 0
Malaga
Country [113] 0 0
Spain
State/province [113] 0 0
Navarra
Country [114] 0 0
Spain
State/province [114] 0 0
Barcelona
Country [115] 0 0
Spain
State/province [115] 0 0
L'Hospitalet de Llobregat
Country [116] 0 0
Spain
State/province [116] 0 0
Las Palmas de Gran Canaria
Country [117] 0 0
Spain
State/province [117] 0 0
Madrid
Country [118] 0 0
Spain
State/province [118] 0 0
Santander
Country [119] 0 0
Spain
State/province [119] 0 0
Sevilla
Country [120] 0 0
Taiwan
State/province [120] 0 0
Chiayi Hsien
Country [121] 0 0
Taiwan
State/province [121] 0 0
Changhua
Country [122] 0 0
Taiwan
State/province [122] 0 0
Tainan
Country [123] 0 0
Taiwan
State/province [123] 0 0
Taipei
Country [124] 0 0
Turkey
State/province [124] 0 0
Ankara
Country [125] 0 0
Turkey
State/province [125] 0 0
Izmir
Country [126] 0 0
Turkey
State/province [126] 0 0
Yenimahalle
Country [127] 0 0
Turkey
State/province [127] 0 0
Istanbul
Country [128] 0 0
United Kingdom
State/province [128] 0 0
Bristol, City Of
Country [129] 0 0
United Kingdom
State/province [129] 0 0
East Riding Of Yorkshire
Country [130] 0 0
United Kingdom
State/province [130] 0 0
Leicestershire
Country [131] 0 0
United Kingdom
State/province [131] 0 0
London, City Of
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Loxo Oncology, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Eli Lilly and Company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05254743