Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia
NCT ID: NCT01109069
Last Updated: 2020-05-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
199 participants
INTERVENTIONAL
2010-06-30
2019-04-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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PCI-32765
PCI-32765
Dose based on parent protocol
Interventions
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PCI-32765
Dose based on parent protocol
Eligibility Criteria
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Inclusion Criteria
* Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 3 days of the first dose of study drug and agree to use dual methods of contraception during the study and for 1 month following the last dose with study drug. Post menopausal females (\>45 years old and without menses for \>1 year) and surgically sterilized females are exempt from this criterion.
* Male subjects must use an effective barrier method of contraception during the study and for 3 months following the last dose if sexually active with a female of childbearing potential.
* Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).
Exclusion Criteria
* Known history of Human Immunodeficiency Virus (HIV) or active infection with Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) or any uncontrolled active systemic infection.
* Lactating or pregnant
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Pharmacyclics LLC.
INDUSTRY
Responsible Party
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Principal Investigators
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James Dean, MD
Role: STUDY_DIRECTOR
Medical Monitor
Locations
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Stanford University
Stanford, California, United States
Stanford, California, United States
University of Chicago
Chicago, Illinois, United States
Boston, Massachusetts, United States
New Hyde Park, New York, United States
New York, New York, United States
Rochester, New York, United States
Columbus, Ohio, United States
Springfield, Oregon, United States
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Houston, Texas, United States
Tyler, Texas, United States
Fletcher Allen Health Care and University of Vermont
Burlington, Vermont, United States
Vancouver, Washington, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States
Countries
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References
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Byrd JC, Furman RR, Coutre SE, Flinn IW, Burger JA, Blum K, Sharman JP, Wierda W, Zhao W, Heerema NA, Luan Y, Liu EA, Dean JP, O'Brien S. Ibrutinib Treatment for First-Line and Relapsed/Refractory Chronic Lymphocytic Leukemia: Final Analysis of the Pivotal Phase Ib/II PCYC-1102 Study. Clin Cancer Res. 2020 Aug 1;26(15):3918-3927. doi: 10.1158/1078-0432.CCR-19-2856. Epub 2020 Mar 24.
Coutre SE, Byrd JC, Hillmen P, Barrientos JC, Barr PM, Devereux S, Robak T, Kipps TJ, Schuh A, Moreno C, Furman RR, Burger JA, O'Dwyer M, Ghia P, Valentino R, Chang S, Dean JP, James DF, O'Brien SM. Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies. Blood Adv. 2019 Jun 25;3(12):1799-1807. doi: 10.1182/bloodadvances.2018028761.
O'Brien S, Furman RR, Coutre S, Flinn IW, Burger JA, Blum K, Sharman J, Wierda W, Jones J, Zhao W, Heerema NA, Johnson AJ, Luan Y, James DF, Chu AD, Byrd JC. Single-agent ibrutinib in treatment-naive and relapsed/refractory chronic lymphocytic leukemia: a 5-year experience. Blood. 2018 Apr 26;131(17):1910-1919. doi: 10.1182/blood-2017-10-810044. Epub 2018 Feb 2.
Provided Documents
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Document Type: Study Protocol
Related Links
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Home page of Pharmacyclics
Other Identifiers
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PCI-32765
Identifier Type: OTHER
Identifier Source: secondary_id
PCYC-1103-CA
Identifier Type: -
Identifier Source: org_study_id
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