ClinicalTrials.gov

History of Changes for Study: NCT01236391
Safety and Efficacy of PCI-32765 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma (MCL) (PCYC-1104-CA)
Latest version (submitted August 24, 2015) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 November 5, 2010 None (earliest Version on record)
2 January 28, 2011 Arms and Interventions, Study Status, Contacts/Locations, Study Design, Eligibility, Outcome Measures and Oversight
3 February 1, 2011 Study Status
4 February 17, 2011 Study Status
5 February 28, 2011 Recruitment Status, Study Description, Study Status, Contacts/Locations and Eligibility
6 April 25, 2011 Study Status and Contacts/Locations
7 April 28, 2011 Contacts/Locations and Study Status
8 May 11, 2011 Study Status and Contacts/Locations
9 May 31, 2011 Contacts/Locations and Study Status
10 June 14, 2011 Study Status and Contacts/Locations
11 September 14, 2011 Sponsor/Collaborators and Study Status
12 September 21, 2011 Study Status and Contacts/Locations
13 September 26, 2011 Contacts/Locations and Study Status
14 October 19, 2011 Contacts/Locations and Study Status
15 November 22, 2011 Study Status and Contacts/Locations
16 November 28, 2011 Contacts/Locations and Study Status
17 November 30, 2011 Contacts/Locations, Study Design, Study Description and Study Status
18 March 2, 2012 Contacts/Locations and Study Status
19 March 9, 2012 Contacts/Locations and Study Status
20 March 19, 2012 Study Status
21 March 21, 2012 Recruitment Status, Contacts/Locations and Study Status
22 April 27, 2012 Study Status and Contacts/Locations
23 May 15, 2013 Contacts/Locations and Study Status
24 June 21, 2013 Study Status
25 February 12, 2014 Recruitment Status, Study Status and Study Design
26 March 4, 2015 Outcome Measures, Study Status, Arms and Interventions, Study Design, Study Description, Results, Contacts/Locations, Sponsor/Collaborators and Study Identification
27 June 12, 2015 Study Status
28 August 24, 2015 Study Status
Comparison Format:

Scroll up to access the controls

Study NCT01236391
Submitted Date:  November 5, 2010 (v1)

Open or close this module Study Identification
Unique Protocol ID: PCYC-1104-CA
Brief Title: Safety and Efficacy of PCI-32765 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma (MCL) (PCYC-1104-CA)
Official Title: Multicenter Phase 2 Study of Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Relapsed or Refractory Mantle Cell Lymphoma
Secondary IDs: PCI-32765 [Pharmacyclics]
Open or close this module Study Status
Record Verification: October 2010
Overall Status: Not yet recruiting
Study Start: December 2010
Primary Completion: December 2012 [Anticipated]
Study Completion: April 2013 [Anticipated]
First Submitted: October 18, 2010
First Submitted that
Met QC Criteria:
November 5, 2010
First Posted: November 8, 2010 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 5, 2010
Last Update Posted: November 9, 2010 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Pharmacyclics LLC.
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary:

The purpose of this study is to:

  1. Evaluate the efficacy of PCI-32765 in relapsed/refractory subjects with MCL who have not had prior bortezomib.
  2. The secondary objective is to evaluate the safety of a fixed daily dosing regimen of PCI-32765 capsules in this population.
Detailed Description: The primary objective of this trial is to evaluate the efficacy of PCI-32765 in relapsed/refractory subjects with MCL who have not had prior bortezomib. The secondary objective is to evaluate the safety of a fixed daily dosing regimen of PCI-32765 capsules in this population.
Open or close this module Conditions
Conditions: Mantle Cell Lymphoma
Keywords: Pharmacyclics
Mantle
Mantle Cell
Lymphoma
Non-Hodgkins
Bortezomib
Velcade
Naive
PCYC
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 50 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: PCI-32765
PCI-32765
Drug: PCI-32765
560 mg daily
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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. ]

Secondary Outcome Measures:
1. 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. ]

2. 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. ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
  • Prior treatment for MCL, as defined below:
    • At least 1, but no more than 3, prior treatment regimens
    • Prior therapy cannot have included bortezomib
  • 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)

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:
    • Absolute neutrophil count (ANC) < 750 cells/mm3 (0.75 x 109/L) unless there is documented bone marrow involvement
    • Platelet count < 50,000 cells/mm3 (50 x 109/L) independent of transfusion support unless there is documented bone marrow involvement
    • Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ≥ 3.0 x upper limit of normal (ULN)
    • Creatinine > 2.0 x ULN
Open or close this module Contacts/Locations
Central Contact Person: Sara Rodriguez
Telephone: 408-215-3455
Email: srodriguez@pcyc.com
Central Contact Backup: Raquel Izumi, PhD
Telephone: 408-215-3341
Email: rizumi@pcyc.com
Study Officials: Eric Hedrick, MD
Study Director
Phramcyclics
Locations: United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Contact:Principal Investigator: Ranjana Advani, MD
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Contact:Contact: Judith Smith, RN judithsmith@humed.com
Contact:Principal Investigator: Andres Goy, MD
United States, New York
New York Presbyterian Hospital/Cornell Medical Center
New York, New York, United States, 94305
Contact:Principal Investigator: Peter Martin, MD
United States, Ohio
The Ohio Sate university
Columbus, Ohio, United States, 43210
Contact:Principal Investigator: Kristine A. Blum, MD
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Contact:Principal Investigator: Michael Wang, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links: Description: www.pharmacyclics.com
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services