A Long-term Extension Study of PCI-32765 (Ibrutinib)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ibrutinib.
- Who it may be relevant to
- Registry conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Belgium, Brazil +25
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
PCI-32765CAN3001: A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study
Overview
The purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment.
Detailed description
This is an open-label (identity of assigned study drug will be known) study designed to collect long-term safety and efficacy data and provide ibrutinib access to participants in completed ibrutinib studies. PCI-32765 (Ibrutinib) is a first-in-class, potent, orally-administered, covalently-binding small molecule inhibitor of bruton's tyrosine kinase. "PCI-32765" and "ibrutinib" refer to the same molecule; hereafter, "ibrutinib" will be used. Participants will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study until the investigator determines that the participant is no longer benefitting from treatment (ie, disease progression or unacceptable toxicity has occurred), the participant withdraws consent, alternative access to ibrutinib is available and feasible (example, participant assistance program or commercial source of ibrutinib), or for other reasons as defined in the protocol, or until the end of the study, whichever occurs earlier. Safety will be monitored throughout the study and summarized. Efficacy may be analyzed in combination with the data collected in the parent protocol. There is no formal hypothesis testing planned for this long-term extension study. Participants for whom alternative access to ibrutinib is not available and feasible can receive treatment with single-agent ibrutinib until end of study, which is defined as the time when all participants still receiving study treatment have transitioned to commercial or alternative access to ibrutinib, have stopped receiving ibrutinib treatment, or upon a decision by the sponsor to terminate the study, whichever occurs earlier.
Interventions
- Drug Ibrutinib
Ibrutinib will be given orally as capsules, once daily continuously, according to the current dosing regimen established in the parent ibrutinib clinical study (560 mg, 420 mg, 280 mg, or 140 mg), at approximately the same time each day.
Primary outcome measures
- Number of participants affected by an adverse event [Time frame: Up to 30 days after the last dose of study drug, or until the start of a subsequent systemic anti-cancer therapy, if earlier]
Secondary outcome measures (1)
- Number of participants with change in disease status [Time frame: Up to the end-of-treatment visit (up to 30 days after the last dose of study medication), or until the start of a subsequent anti-caner therapy, if earlier]
Eligibility criteria
Inclusion criteria
- Participants must be currently participating in an ibrutinib clinical study considered complete and have received at least 6 months of treatment with ibrutinib. At study entry, participants must be actively receiving treatment with single-agent ibrutinib; or participants must have participated in an ibrutinib randomized clinical study in which they initially received comparator treatment and now cross-over to ibrutinib. Note: A minimum of 6 months requirement for prior ibrutinib treatment will not be mandatory in this case and participants with less than 6 months will be required to have more frequent initial safety assessments; or participants must be currently participating in study PCI-32765LYM1002. At study entry, participants must be actively receiving combination treatment with ibrutinib and nivolumab or single-agent ibrutinib
- Investigator's assessment that the benefit of continued ibrutinib therapy as a single agent or in combination with nivolumab will outweigh the risks
- Agrees to protocol-defined use of effective contraception
- Negative blood or urine pregnancy test at screening
Exclusion criteria
- Requires anticoagulation with warfarin or equivalent vitamin K antagonists
- Requires treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors, unless previously approved by sponsor
- Any condition or situation which, in the opinion of the investigator, may put the participant at significant risk, may confound the study results, or may interfere significantly with volunteer's participation in the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 32 centers
- City of Hope Cancer Center — Duarte
- University of California San Diego Medical Center — La Jolla
- University of California Los Angeles — Los Angeles
- St. Joseph Hospital Center for Cancer Prevention and Treatment — Orange
- Stanford University Medical Center — Stanford
- Stanford University — Stanford
- Norwalk Medical Group — Norwalk
- Northwest Georgia Oncology Centers PC — Marietta
- … and 24 more centers
Russia · 18 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 16 centers
Center list to be confirmed — check the primary protocol.
China · 12 centers
- Peking University People's Hospital — Beijing
- Peking University Third Hospital — Beijing
- Peking University First Hospital — Beijing
- West China Hospital Sichuan University — Chengdu
- Fujian Medical University — Fuzhou
- Sun Yat-sen University Cancer Hospital — Guangzhou
- Zhejiang University First Hospital — Hangzhou
- Ruijin Hospital — Shanghai
- … and 4 more centers
Germany · 9 centers
- Vivantes Klinikum Spandau-Klinik f. Innere Medizin Hämatologie/Onkologie/Gastroenterologie — Berlin
- Universitätsklinikum Carl Gustav Carus; Med. Klinik und Poliklinik I - Hämatologische Ambu — Dresden
- Universitätsklinikum Essen; Klinik f. Hämatologie- Germany — Essen
- Justus-Liebig-Universitaet - Medizinische Klinik IV, Haematologie — Giessen
- … and 5 more centers
Australia · 8 centers
- Royal Adelaide Hospital — Adelaide
- John Fawkner Cancer Trial Centre — Coburg
- Concord Hospital — Concord
- Austin Health — Heidelberg
- Peter MacCallum Cancer Centre — Melbourne
- Royal Perth Hospital — Perth
- Alfred Hospital — Prahran
- Adventist Health Care Limited trading as San Clinical Trials Unit — Wahroonga
Poland · 8 centers
Center list to be confirmed — check the primary protocol.
Spain · 8 centers
Center list to be confirmed — check the primary protocol.
France · 7 centers
- Hopital Henri Mondor — Créteil
- Hôpital E. Muller — Mulhouse
- HOPITAL SAINT LOUIS - Hematology / Oncology — Paris
- Hopital Necker Enfants Malades — Paris
- Hopital Haut Leveque Service Maladie Du Sang — Pessac
- CH LYON SUD - Hematology — Pierre-Bénite
- CHU de Tours — Tours
Ukraine · 7 centers
Center list to be confirmed — check the primary protocol.
Belgium · 6 centers
- UZA — Antwerp
- A.Z. Sint Jan — Bruges
- UCL - Saint Luc — Brussels
- UZ Gent - departement oncologie — Ghent
- UZ Leuven Gasthuisberg — Leuven
- UCL Mont-Godinne — Yvoir
Israel · 6 centers
Center list to be confirmed — check the primary protocol.
Turkey (Türkiye) · 5 centers
Center list to be confirmed — check the primary protocol.
Brazil · 3 centers
- Ministerio da Saude Instituto Nacional do Cancer — Rio de Janeiro
- Santa Casa da Misericórdia da Bahia - Hospital Santa Isabel — Salvador
- Instituto de Ensino e Pesquisa São Lucas — São Paulo
Czechia · 3 centers
- Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika — Brno
- Fakultni nemocnice Kralovske Vinohrady - Interni hematologicka klinika — Prague
- Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie — Prague
Italy · 3 centers
Center list to be confirmed — check the primary protocol.
Portugal · 3 centers
Center list to be confirmed — check the primary protocol.
Sweden · 3 centers
Center list to be confirmed — check the primary protocol.
Argentina · 2 centers
- CEMIC Saavedra — Ciudad Autonoma Buenos Aires
- Fundaleu — Ciudad de Buenos Aires
Colombia · 2 centers
- Fundacion Santa Fe — Bogotá
- Fundacion Oftalmologica de Santander - FOSCAL — Floridablanca
Greece · 2 centers
Center list to be confirmed — check the primary protocol.
Hungary · 2 centers
Center list to be confirmed — check the primary protocol.
Japan · 2 centers
Center list to be confirmed — check the primary protocol.
South Korea · 2 centers
Center list to be confirmed — check the primary protocol.
Canada · 1 center
- Jewish General Hospital — Montreal
Ireland · 1 center
Center list to be confirmed — check the primary protocol.
Mexico · 1 center
Center list to be confirmed — check the primary protocol.
Netherlands · 1 center
Center list to be confirmed — check the primary protocol.
Puerto Rico · 1 center
Center list to be confirmed — check the primary protocol.
Taiwan · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT01804686 · CR100955 · PCI-32765CAN3001 · 2012-004225-24