MedDRA version: 20.0 Level: PT Classification code 10043515 Term: Throat cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.1 Level: LLT Classification code 10054695 Term: Waldenstrom's macroglobulinemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.1 Level: LLT Classification code 10008976 Term: Chronic lymphocytic leukemia System Organ Class: 10029
Conditions
Sponsors
Pharmacyclics Switzerland GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject must currently be participating in an ibrutinib clinical trial, deriving clinical benefit from treatment with ibrutinib in the opinion of the treating physician and do no thave access to commercial ibrutinib within their region (eg, no regulatory approval ,insufficient reimbursement, and/or insufficient insurer coverage for the indication). 2. Ongoing continuous treatment with ibrutinib: ibrutinib treatment may be on temporary hold at the time of enrollment with less than 28 continuous doses missed, however, the decision cannot have been made to permanently discontinue ibrutinib treatment. 3. Subject must have completed all assessments in their parent protocol (eg, End-of-Treatment Visit is completed) and want to continue treatment with ibrutinib. 4.Subject has provided informed consent to the long-term treatment extension protocol and not withdrawn consent from the parent study. 5.Male and female subjects of reproductive potential who agree to use both a highly effective method of birth control (as desribed in the protocol) during the period of therapy and for 90 days for females and males after the last dose of drug. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 250
Exclusion criteria
Exclusion criteria: 1. Meeting any requirement in the parent protocol to permanently discontinue ibrutinib treatment. 2. Any condition or situation which, in the opinion of the treating physician, may interfere significantly with a subject’s participation in the protocol. 3. Female subjects who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this protocol or within 90 days of last dose of drug treatment. Male subjects who plan to father a child while enrolled in this protocol or within 90 days after the last dose of drug treatment. 4. Unwilling or unable to participate in all required evaluations and procedures. 5. Unable to understand the purpose and risks of the protocol and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information(in accordance with national and local subject privacy regulations).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To provide long-term access to ibrutinib for subjects who have been enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and are deriving benefit as assessed by the treating physician;Secondary Objective: Further key objective is to collect long-term safety data for these subjects treated with ibrutinib and to characterize the drug safety profile in long-term treatment with ibrutinib.;Primary end point(s): There is no specific primary endpoint. ;Timepoint(s) of evaluation of this end point: Not applicable. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Long-term safety.;Timepoint(s) of evaluation of this end point: After the termination of the study. | — |
Countries
Australia, Austria, Belgium, Canada, China, Czech Republic, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Korea, Republic of, New Zealand, Poland, Russian Federation, Spain, Sweden, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactMedical Monitor
Pharmacyclics Switzerland GmbH
Outcome results
None listed