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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/NCT01779791




Registration number
NCT01779791
Ethics application status
Date submitted
25/01/2013
Date registered
30/01/2013
Date last updated
18/07/2017

Titles & IDs
Public title
A Study of PCI-32765 (Ibrutinib) in Patients With Refractory Follicular Lymphoma
Scientific title
An Open-Label, Multicenter, Single-Arm, Phase 2 Study of PCI-32765 (Ibrutinib) in Subjects With Refractory Follicular Lymphoma
Secondary ID [1] 0 0
2012-004097-26
Secondary ID [2] 0 0
CR100956
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PCI-32765 (Ibrutinib)

Experimental: PCI-32765 (Ibrutinib) -


Treatment: Drugs: PCI-32765 (Ibrutinib)
560 mg capsules administered orally once daily, continuously on a 21-day cycle until progressive disease.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall response rate
Timepoint [1] 0 0
Up to 2 years after the last patient is enrolled
Secondary outcome [1] 0 0
Duration of response
Timepoint [1] 0 0
Every 12 weeks during the first 96 weeks, followed by every 24 weeks thereafter until disease progression (up to 2 years after the last patient is enrolled)
Secondary outcome [2] 0 0
Progression-free survival
Timepoint [2] 0 0
Up to progressive disease, death, lost to follow-up, withdrawal of consent, or study end (up to 2 years after the last patient is enrolled)
Secondary outcome [3] 0 0
Overall survival
Timepoint [3] 0 0
Up to death, lost to follow-up, withdrawal of consent, or study end (up to 2 years after the last patient is enrolled)
Secondary outcome [4] 0 0
Time to response
Timepoint [4] 0 0
Every 12 weeks during the first 96 weeks, followed by every 24 weeks thereafter until disease progression (up to 2 years after the last patient is enrolled)
Secondary outcome [5] 0 0
Number of patients experiencing resolution of lymphoma-related B symptoms
Timepoint [5] 0 0
Day 1 of every cycle during the first 12 months, thereafter every other cycle (up to 2 years after the last patient is enrolled)
Secondary outcome [6] 0 0
Number of patients identified with blood biomarkers that alter B-cell receptor signaling or activate alternative signaling pathways
Timepoint [6] 0 0
Day 1 of Cycles 1-3, and time of disease progression, or at end-of treatment visit for patients who discontinue treatment without disease progression
Secondary outcome [7] 0 0
Minimum plasma concentration of PCI-32765
Timepoint [7] 0 0
Pre-dose Day 1 of Cycles 1-3, post-dose Day 1 of Cycles 1, 2 at 1, 2, and 4 hours
Secondary outcome [8] 0 0
Oral plasma clearance of PCI-32765
Timepoint [8] 0 0
Pre-dose Day 1 of Cycles 1-3, post-dose Day 1 of Cycles 1, 2 at 1, 2, and 4 hours
Secondary outcome [9] 0 0
Oral volume of distribution at steady state of PCI-32765
Timepoint [9] 0 0
Pre-dose Day 1 of Cycles 1-3, post-dose Day 1 of Cycles 1, 2 at 1, 2, and 4 hours
Secondary outcome [10] 0 0
Area under the plasma-concentration time curve of PCI-32765
Timepoint [10] 0 0
Pre-dose Day 1 of Cycles 1-3, post-dose Day 1 of Cycles 1, 2 at 1, 2, and 4 hours
Secondary outcome [11] 0 0
Number of participants affected by an adverse event
Timepoint [11] 0 0
Up to 30 days after the last dose of study medication

Eligibility
Key inclusion criteria
- Histologic proof of Grade 1, 2, or 3a follicular lymphoma (FL) without clinical or
pathological evidence of transformation

- Previously treated with at least 2 prior lines of therapy, including at least 1
rituximab combination chemotherapy regimen; last prior line of therapy includes an
anti CD20 monoclonal antibody-containing chemotherapy regimen (separate lines of
therapy are defined as different regimens that are either separated by disease
progression, refractory disease, or relapsed disease)

- Resistant disease to the last therapy, defined as progression of disease during or
within 12 months of the last dose of chemotherapy in a CD20 antibody combination
chemotherapy regimen

- At least 1 measurable site of disease according to International Working Group Revised
Response Criteria for Malignant Lymphoma

- Eastern Cooperative Oncology Group performance status grade 0 or 1

- Hematology and biochemical laboratory values must be within protocol-defined
parameters within 7 days prior to enrollment

- Agrees to protocol-defined use of effective contraception

- Women of childbearing potential must have a negative serum or urine pregnancy test at
screening
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior nitrosoureas within 6 weeks, chemotherapy within 3 weeks, therapeutic anticancer
antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10 weeks, radiation
therapy or other investigational agents within 3 weeks, or major surgery within 4
weeks of first dose of study drug

- Prior treatment with PCI-32765 or other Bruton's tyrosine kinase inhibitors (patients
who progressed or became refractory while on treatment with PI3K inhibitors are
excluded)

- Concurrent enrollment in another therapeutic investigational clinical treatment study

- Received a prior allogeneic hematopoietic stem cell transplant (prior autologous
hematopoietic stem cell transplant is allowed)

- Known central nervous system lymphoma

- History of prior malignancy (except malignancy treated with curative intent and with
no known active disease present for >=3 years before enrollment, adequately treated
non-melanoma skin cancer or lentigo maligna without evidence of disease, or adequately
treated cervical carcinoma in situ without evidence of disease)

- History of stroke or intracranial hemorrhage within 6 months prior to enrollment

- Requires anticoagulation with warfarin or equivalent vitamin K antagonists

- Requires treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors

- Clinically significant cardiovascular disease such as uncontrolled or symptomatic
arrhythmias, congestive heart failure, or myocardial infarction within 6 months of
screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by
the New York Heart Association Functional Classification

- Known history of Human Immunodeficiency Virus (HIV) or active infection with Hepatitis
C or active infection with Hepatitis B or any uncontrolled active systemic infection
requiring intravenous antibiotics

- Women who are pregnant or breastfeeding

- Any life-threatening illness, medical condition, or organ system dysfunction which, in
the investigator's opinion, could compromise the patient's safety, interfere with the
absorption or metabolism of PCI-32765 capsules, or put the study outcomes at undue
risk

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/04/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/05/2016
Sample size
Target
Accrual to date
Final
110
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Concord
Recruitment hospital [3] 0 0
- Melbourne
Recruitment hospital [4] 0 0
- Milton
Recruitment hospital [5] 0 0
- Prahran
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Concord
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Milton
Recruitment postcode(s) [5] 0 0
- Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Vermont
Country [16] 0 0
United States of America
State/province [16] 0 0
Washington
Country [17] 0 0
Belgium
State/province [17] 0 0
Courrière
Country [18] 0 0
Belgium
State/province [18] 0 0
Gent
Country [19] 0 0
Belgium
State/province [19] 0 0
Leuven
Country [20] 0 0
France
State/province [20] 0 0
Creteil
Country [21] 0 0
France
State/province [21] 0 0
Nice Cedex 2
Country [22] 0 0
France
State/province [22] 0 0
Nimes Cedex 9
Country [23] 0 0
France
State/province [23] 0 0
Paris
Country [24] 0 0
France
State/province [24] 0 0
Pessac
Country [25] 0 0
France
State/province [25] 0 0
Pierre Benite
Country [26] 0 0
France
State/province [26] 0 0
Rennes
Country [27] 0 0
Germany
State/province [27] 0 0
Heidelberg
Country [28] 0 0
Germany
State/province [28] 0 0
Köln
Country [29] 0 0
Germany
State/province [29] 0 0
Mainz
Country [30] 0 0
Germany
State/province [30] 0 0
Ulm
Country [31] 0 0
Poland
State/province [31] 0 0
Krakow
Country [32] 0 0
Poland
State/province [32] 0 0
Warszawa
Country [33] 0 0
Poland
State/province [33] 0 0
Wroclaw
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Ekaterinburg
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Moscow N/A
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Nizhny Novgorod
Country [37] 0 0
Russian Federation
State/province [37] 0 0
St-Petersburg
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Volgograd
Country [39] 0 0
Spain
State/province [39] 0 0
Barcelona
Country [40] 0 0
Spain
State/province [40] 0 0
Marbella
Country [41] 0 0
Spain
State/province [41] 0 0
Salamanca
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Liverpool
Country [43] 0 0
United Kingdom
State/province [43] 0 0
London
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Manchester
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Pharmacyclics LLC.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib)
administered to patients with chemoimmunotherapy-resistant follicular lymphoma (FL).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01779791
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01779791