A Study to Evaluate the Efficacy and Safety of Ibrutinib, in Patients With Mantle Cell Lymphoma Who Progress After Bortezomib Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pharmacyclics
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01599949
First received: May 14, 2012
Last updated: August 28, 2014
Last verified: August 2014

May 14, 2012
August 28, 2014
August 2012
April 2015   (final data collection date for primary outcome measure)
Overall response rate [ Time Frame: 1 year after the last patient is enrolled ] [ Designated as safety issue: No ]
Overall response rate [ Time Frame: 6 months after the last patient is enrolled ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01599949 on ClinicalTrials.gov Archive Site
  • Overall survival rate [ Time Frame: 1 year after the last patient is enrolled and 2 years after the last patient is enrolled ] [ Designated as safety issue: No ]
  • Progression-free survival rate [ Time Frame: 1 year after the last patient is enrolled and 2 years after the last patient is enrolled ] [ Designated as safety issue: No ]
  • Mean change from baseline in the Lym subscale [ Time Frame: 1 year after the last patient is enrolled and 2 years after the last patient is enrolled ] [ Designated as safety issue: No ]
  • Mean change from baseline in the EQ-5D-5L index [ Time Frame: 1 year after the last patient is enrolled and 2 years after the last patient is enrolled ] [ Designated as safety issue: No ]
  • Mean plasma concentrations of ibrutinib [ Time Frame: Up to Cycle 2, Day 21 ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration of ibrutinib [ Time Frame: Up to Cycle 2, Day 21 ] [ Designated as safety issue: No ]
  • Minimum observed plasma concentration of ibrutinib [ Time Frame: Up to Cycle 2, Day 21 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time 0 to 24 hours of ibrutinib [ Time Frame: Up to Cycle 2, Day 21 ] [ Designated as safety issue: No ]
  • The number of participants affected by an adverse event [ Time Frame: Up to 30 days after the last dose of study medication ] [ Designated as safety issue: Yes ]
  • Overall response rate [ Time Frame: 1 year after the last patient is enrolled and 2 years after the last patient is enrolled ] [ Designated as safety issue: No ]
  • Overall survival rate [ Time Frame: 6 months after the last patient is enrolled and 2 years after the last patient is enrolled ] [ Designated as safety issue: No ]
  • Progression-free survival rate [ Time Frame: 6 months after the last patient is enrolled and 2 years after the last patient is enrolled ] [ Designated as safety issue: No ]
  • Mean change from baseline in the Lym subscale [ Time Frame: 6 months after the last patient is enrolled and 2 years after the last patient is enrolled ] [ Designated as safety issue: No ]
  • Mean change from baseline in the EQ-5D-5L index [ Time Frame: 6 months after the last patient is enrolled and 2 years after the last patient is enrolled ] [ Designated as safety issue: No ]
  • Mean plasma concentrations of ibrutinib [ Time Frame: Up to Cycle 2, Day 21 ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration of ibrutinib [ Time Frame: Up to Cycle 2, Day 21 ] [ Designated as safety issue: No ]
  • Minimum observed plasma concentration of ibrutinib [ Time Frame: Up to Cycle 2, Day 21 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time 0 to 24 hours of ibrutinib [ Time Frame: Up to Cycle 2, Day 21 ] [ Designated as safety issue: No ]
  • The number of participants affected by an adverse event [ Time Frame: Up to 30 days after the last dose of study medication ] [ Designated as safety issue: Yes ]
  • Overall response rate [ Time Frame: 6 months after the last patient is enrolled and 2 years after the last patient is enrolled ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study to Evaluate the Efficacy and Safety of Ibrutinib, in Patients With Mantle Cell Lymphoma Who Progress After Bortezomib Therapy
A Phase 2, Multicenter, Single-Arm, Study to Evaluate the Efficacy and Safety of Single-Agent Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Subjects With Mantle Cell Lymphoma Who Progress After Bortezomib Therapy

The purpose of this study is to evaluate the efficacy and safety of ibrutinib in patients with mantle cell lymphoma who received at least 1 prior rituximab-containing chemotherapy regimen and who progressed after bortezomib therapy.

This is a single-arm (all patients will receive the study drug) study to evaluate the efficacy and safety of ibrutinib in patients with mantle cell lymphoma (MCL) who have received at least 1 rituximab-containing chemotherapy regimen and who progressed after bortezomib therapy. Approximately 110 eligible patients will be enrolled. During the treatment phase, patients will receive 560 mg of ibrutinib by mouth once daily continuously until disease progression, unacceptable toxicity, or study end, whichever occurs first. Treatment will be continuous (without interruption) and self-administered at home. Doses can be held or reduced based on the severity of and the recovery from side effects of the study drug. The sponsor will ensure that patients benefiting from treatment with ibrutinib will be able to continue treatment after the end of the study. Data will be collected on disease response to the treatment, on progression-free survival, overall survival, and subsequent anti-MCL therapies. Serial pharmacokinetic (study of what the body does to a drug) samples will be collected as detailed in the protocol. Safety will be monitored throughout the study. An interim analysis of the pharmacokinetic data will occur approximately 3 months after the scheduled pharmacokinetic sampling in Cycles 1 and 2 has been completed. Data will be analyzed 1 year after the last patient is enrolled for the primary analysis and 2 years after last patient is enrolled for the final follow-up.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Mantle Cell Lymphoma
Drug: Ibrutinib
Type=exact number, unit=mg, number=560, form=capsule, route=oral use. 560 mg oral ibrutinib is to be administered once daily continuously until disease progression, unacceptable toxicity, or study end, whichever occurs first. Doses can be held or reduced based on the severity of and the recovery from side effects of the study drug.
Experimental: Ibrutinib
Intervention: Drug: Ibrutinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
April 2015
April 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of confirmed mantle cell lymphoma (MCL) with at least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma
  • Must have received at least 1 prior rituximab-containing chemotherapy regimen, but no more than 5 prior regimens
  • Must have received at least 2 cycles of bortezomib therapy (single-agent or in combination) and have documented progressive disease during or after bortezomib therapy
  • Eastern Cooperative Oncology Group performance status score 0, 1, or 2
  • Hematology and biochemical values within protocol-defined parameters

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 or other investigational agents within 3 weeks, or major surgery within 4 weeks of the first dose of study drug
  • Prior treatment with ibrutinib or other Bruton's tyrosine kinase inhibitors
  • More than 5 prior lines of therapy (separate lines of therapy are defined as single or combination therapies that are either separated by disease progression or by a >6 month treatment-free interval
  • Known central nervous system lymphoma
  • Diagnosed or treated for malignancy other than MCL, except malignancy treated with curative intent and with no known active disease present for >=3 years before the first dose of study drug and felt to be at low risk for recurrence by the treating physician, 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 the first dose of study drug
  • Requires anticoagulation with warfarin or equivalent vitamin K antagonists
  • Requires treatment with strong CYP3A4/5 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 or active infection with hepatitis C virus or hepatitis B virus or any uncontrolled active systemic infection
  • 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 ibrutinib capsules, or put the study outcomes at undue risk
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   United States,   United Kingdom,   France,   Israel,   Poland,   Puerto Rico,   Russian Federation,   Spain
 
NCT01599949
CR100847, PCI-32765MCL2001, 2012-000711-88
No
Janssen Research & Development, LLC
Janssen Research & Development, LLC
Pharmacyclics
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Janssen Research & Development, LLC
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP