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Multicenter Phase 2 Study of Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Relapsed or Refractory Mantle Cell Lymphoma

Phase 2
18 Years
Open (Enrolling)
Mantle Cell Lymphoma

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Trial Information

Multicenter Phase 2 Study of Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Relapsed or Refractory Mantle Cell Lymphoma

The primary objective of this trial is to evaluate the efficacy of PCI-32765 in
relapsed/refractory subjects with MCL. The secondary objective is to evaluate the safety of
a fixed daily dosing regimen of PCI-32765 capsules in this population.

Inclusion Criteria:

- Men and women ≥ 18 years of age

- ECOG performance status of ≤ 2

- Pathologically confirmed MCL, with documentation of either overexpression of cyclin
D1 or t(11;14), and measurable disease on cross sectional imaging that is ≥ 2 cm in
the longest diameter and measurable in 2 perpendicular dimensions

- Documented failure to achieve at least partial response (PR) with, or documented
disease progression disease after, the most recent treatment regimen

- At least 1, but no more than 5, prior treatment regimens for MCL (Note: Subjects
having received ≥2 cycles of prior treatment with bortezomib, either as a single
agent or as part of a combination therapy regimen, will be considered to be

- 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 subject privacy regulations)

Major exclusion criteria:

- Prior chemotherapy within 3 weeks, nitrosoureas within 6 weeks, therapeutic
anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10
weeks, radiation therapy within 3 weeks, or major surgery within 2 weeks of first
dose of study drug

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

- 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 or 4 cardiac disease as defined by the New York Heart
Association Functional Classification

- Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
resection of the stomach or small bowel or ulcerative colitis, symptomatic
inflammatory bowel disease, or partial or complete bowel obstruction

- Any of the following laboratory abnormalities:

1. Absolute neutrophil count (ANC) < 750 cells/mm3 (0.75 x 109/L) unless there is
documented bone marrow involvement

2. Platelet count < 50,000 cells/mm3 (50 x 109/L) independent of transfusion
support unless there is documented bone marrow involvement

3. Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ≥ 3.0
x upper limit of normal (ULN)

4. Creatinine > 2.0 x ULN

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To Measure the Number of Participants with a Response to Study Drug

Outcome Time Frame:

Participants will be followed until progression of disease or start of another anti-cancer treatment.

Safety Issue:


Principal Investigator

Darrin Beaupre, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

February 2011

Completion Date:

March 2014

Related Keywords:

  • Mantle Cell Lymphoma
  • Pharmacyclics
  • Mantle
  • Mantle Cell
  • Lymphoma
  • Non-Hodgkins
  • Bortezomib
  • Velcade
  • Naive
  • PCYC
  • Lymphoma
  • Lymphoma, Mantle-Cell



MD Anderson Cancer Center Houston, Texas  77030-4096
Hackensack University Medical Center Hackensack, New Jersey  07601
Stanford University School of Medicine Stanford, California  94305-5317
Oregon Health & Science University Portland, Oregon  97201
University of Wisconsin Madison,, Wisconsin  53792-5666
New York Presbyterian Hospital/Cornell Medical Center New York, New York  10021
CLL Research and Treatment Program New Hyde Park, New York  11042
The Ohio Sate university Columbus, Ohio  43210
University of Virginia School of Medicine Hospital Charlottesville, Virginia  22908