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Safety and Efficacy of PCI-32765 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma (MCL) (PCYC-1104-CA)

This study has been completed.
Information provided by (Responsible Party):
Pharmacyclics Identifier:
First received: October 18, 2010
Last updated: February 12, 2014
Last verified: February 2014

The purpose of this study is to:

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

Condition Intervention Phase
Mantle Cell Lymphoma
Drug: PCI-32765
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Phase 2 Study of Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Relapsed or Refractory Mantle Cell Lymphoma

Resource links provided by NLM:

Further study details as provided by Pharmacyclics:

Primary Outcome Measures:
  • To Measure the Number of Participants with a Response to Study Drug [ Time Frame: Participants will be followed until progression of disease or start of another anti-cancer treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To Measure the Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Participants will be followed until progression of disease or start of another anti-cancer treatment. ] [ Designated as safety issue: Yes ]
  • To Measure the Number of Participants Pharmacokinetics to Assist in Determining How the Body Responds to the Study Drug [ Time Frame: Procedure to be Performed During the First Month of Receiving Study Drug. ] [ Designated as safety issue: Yes ]
  • Patient Reported Outcomes [ Time Frame: Participants will be followed until progression of disease or start of another anti-cancer treatment. ] [ Designated as safety issue: No ]
    To measure the number of participants reported outcomes in determing the health related quality of life.

Enrollment: 115
Study Start Date: February 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PCI-32765 Prior Bortezomib Treatment
PCI-32765 for patients who have failed previous bortezomib treatment
Drug: PCI-32765
560 mg daily
Experimental: PCI-32765 Bortezomib naive
PCI-32765 for patients who have not previously been treated with Bortezomib
Drug: PCI-32765
560 mg daily

Detailed Description:

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 bortezomib-exposed.)
  • 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 risk
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01236391

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Cll Research and Treatment Program
New Hyde Park, New York, United States, 11042
New York Presbyterian Hospital/Cornell Medical Center
New York, New York, United States, 94305
United States, Ohio
The Ohio Sate university
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia School of Medicine Hospital
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Klinikum der Universitat Munchen - Campus Grosshadern
Munchen, Germany, D - 81377
Universitatsklinikum Ulm, Klinik fur Innere Medizin II
ULM, Germany, 89081
Oddzail Kliniczny Onkologil
Bydgoszcz, Poland, 85-796
Malopolskie Centrum Medyczne
Krakow, Poland, 30-510
MTZ Clinical Research Sp. z o.o.
Warsaw, Poland, 02-106
United Kingdom
Centre for Experimental Cancer Medicine
London, United Kingdom, EC1M6BQ
Christie Hospital
Manchester, United Kingdom, M20 4BX
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Study Director: Darrin Beaupre, MD, PhD Phramcyclics
  More Information

Additional Information:
No publications provided by Pharmacyclics

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Pharmacyclics Identifier: NCT01236391     History of Changes
Other Study ID Numbers: PCYC-1104-CA, PCI-32765
Study First Received: October 18, 2010
Last Updated: February 12, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Ethics Commission
Germany: Ministry of Health
Poland: Ethics Committee
Poland: Ministry of Health

Keywords provided by Pharmacyclics:
Mantle Cell

Additional relevant MeSH terms:
Lymphoma, Mantle-Cell
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on February 27, 2015