Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-24 @ 2:56 PM
NCT ID:
NCT02457559
Eligibility Criteria:
Key Inclusion Criteria:
* Currently enrolled in a prior tirabrutinib study
* Did not discontinue treatment with tirabrutinib for any reason other than to enroll in this study
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at enrollment in this study
* Any Grade 3 or 4 non-hematologic toxicity that the investigator considers related to previous tirabrutinib use must have resolved, reverted to Grade 1, or reverted to the baseline of the prior study prior to Day 1 of this study
* Negative serum and urine pregnancy test is required for female individuals (unless surgically sterile or greater than 2 years post menopausal)
* Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in the protocol
* Lactating females must agree to discontinue nursing before the study drug is administered
* Ability and agreement to attend protocol-specified visits at the study site
* Able to comprehend and willing to sign the informed consent form
Key Exclusion Criteria:
* Known hypersensitivity to tirabrutinib, its metabolites, or formulation excipients
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02457559
Study Brief:
Protocol Section:
NCT02457559