Study to Evaluate the Safety and Tolerability of Tirabrutinib (ONO/GS-4059) Given as Monotherapy in Participants With Relapsed/Refractory NHL and CLL
NCT ID: NCT01659255
Last Updated: 2021-03-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
90 participants
INTERVENTIONAL
2012-08-17
2016-01-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tirabrutinib 20 mg Once Daily (CLL)
Participants with relapsed/refractory chronic lymphocytic leukaemia (CLL) received tirabrutinib 20 mg once daily.
Tirabrutinib
Capsules administered orally
Tirabrutinib 40 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 40 mg once daily.
Tirabrutinib
Capsules administered orally
Tirabrutinib 80 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 80 mg once daily.
Tirabrutinib
Capsules administered orally
Tirabrutinib 160 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 160 mg once daily.
Tirabrutinib
Capsules administered orally
Tirabrutinib 320 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 320 mg once daily.
Tirabrutinib
Capsules administered orally
Tirabrutinib 400 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 400 mg once daily.
Tirabrutinib
Capsules administered orally
Tirabrutinib 500 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 500 mg once daily.
Tirabrutinib
Capsules administered orally
Tirabrutinib 600 mg Once Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 600 mg once daily.
Tirabrutinib
Capsules administered orally
Tirabrutinib 300 mg Twice Daily (CLL)
Participants with relapsed/refractory CLL received tirabrutinib 300 mg twice daily.
Tirabrutinib
Capsules administered orally
Tirabrutinib 20 mg Once Daily (NHL)
Participants with relapsed/refractory non-Hodgkin's lymphoma (NHL) received tirabrutinib 20 mg once daily.
Tirabrutinib
Capsules administered orally
Tirabrutinib 40 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 40 mg once daily.
Tirabrutinib
Capsules administered orally
Tirabrutinib 80 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 80 mg once daily.
Tirabrutinib
Capsules administered orally
Tirabrutinib 160 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 160 mg once daily.
Tirabrutinib
Capsules administered orally
Tirabrutinib 320 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 320 mg once daily.
Tirabrutinib
Capsules administered orally
Tirabrutinib 480 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 480 mg once daily.
Tirabrutinib
Capsules administered orally
Tirabrutinib 600 mg Once Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 600 mg once daily.
Tirabrutinib
Capsules administered orally
Tirabrutinib 240 mg Twice Daily (NHL)
Participants with relapsed/refractory NHL received tirabrutinib 240 mg twice daily.
Tirabrutinib
Capsules administered orally
Interventions
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Tirabrutinib
Capsules administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years.
3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
Exclusion Criteria
2. Women who are pregnant or lactating.
18 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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CHRU - Hopital Claude HURIEZ
Lille, , France
Centre hospitalier Lyon Sud
Lyon, , France
CHU St Eloi
Montpellier, , France
University Hospital of Wales
Cardiff, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Countries
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References
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Walter HS, Salles GA, Dyer MJ. New Agents to Treat Chronic Lymphocytic Leukemia. N Engl J Med. 2016 Jun 2;374(22):2185-6. doi: 10.1056/NEJMc1602674. No abstract available.
Walter HS, Rule SA, Dyer MJ, Karlin L, Jones C, Cazin B, Quittet P, Shah N, Hutchinson CV, Honda H, Duffy K, Birkett J, Jamieson V, Courtenay-Luck N, Yoshizawa T, Sharpe J, Ohno T, Abe S, Nishimura A, Cartron G, Morschhauser F, Fegan C, Salles G. A phase 1 clinical trial of the selective BTK inhibitor ONO/GS-4059 in relapsed and refractory mature B-cell malignancies. Blood. 2016 Jan 28;127(4):411-9. doi: 10.1182/blood-2015-08-664086. Epub 2015 Nov 5.
Fegan, C, Bagshawe J, Salles G, et al. The Bruton's tyrosine kinase (BTK) inhibitor ONO-4059: promising single agent activity and well tolerated in patients with high risk chronic lymphocytic leukaemia (CLL). Paper presented at: 56th American Society of Hematology Annual Meeting and Exposition; December 6-9, 2014; San Franscisco, CA.
Morschhauser F, Terriou L, Dyer M, et al. The Bruton's tyrosine kinase (BTK) inhibitor ONO-4059: promising single agent activity in patients with relapsed and refractory NHL. Haematologica. 2014 Jun; 99: 150.
Other Identifiers
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2011-005033-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ONO-4059POE001
Identifier Type: -
Identifier Source: org_study_id
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