A Study to Evaluate the Efficacy and Safety of Ibrutinib, in Patients With Mantle Cell Lymphoma Who Progress After Bortezomib Therapy
This study is currently recruiting participants.
Verified May 2013 by Janssen Research & Development, LLC
Sponsor:
Janssen Research & Development, LLC
Collaborator:
Pharmacyclics
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01599949
First received: May 14, 2012
Last updated: May 9, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Mantle Cell Lymphoma |
Drug: Ibrutinib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Janssen Research & Development, LLC:
Primary Outcome Measures:
- Overall response rate [ Time Frame: 6 months after the last patient is enrolled ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 110 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ibrutinib |
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.
|
Detailed Description:
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. Data will be analyzed 6 months after the last patient is enrolled for the primary analysis and 2 years after last patient is enrolled for the final follow-up.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01599949
Show 57 Study Locations
Contacts
| Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | JNJ.CT@sylogent.com |
Show 57 Study LocationsSponsors and Collaborators
Janssen Research & Development, LLC
Pharmacyclics
Investigators
| Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
More Information
Additional Information:
No publications provided
| Responsible Party: | Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier: | NCT01599949 History of Changes |
| Other Study ID Numbers: | CR100847, PCI-32765MCL2001, 2012-000711-88 |
| Study First Received: | May 14, 2012 |
| Last Updated: | May 9, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Federal Government |
Keywords provided by Janssen Research & Development, LLC:
|
Mantle cell lymphoma Ibrutinib Bruton's tyrosine kinase inhibitor Rituximab Bortezomib |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Lymphoma, Non-Hodgkin Bortezomib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013