Phase 1
Completed N=29
Study to Assess the Long-term Safety and Efficacy of Tirabrutinib in Adults With Relapsed/Refractory B-cell Malignancies
Relapsed/Refractory B-cell Malignancies
Source: ClinicalTrials.gov NCT02457559 ↗
Enrolled (actual)
29
Serious AEs
69.0%
Results posted
Mar 2022
Primary outcomePrimary: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs) — 100.0; 100.0; 100.0; 100.0 percentage of participants
Summary
The primary objective of this study is to determine the long-term safety and tolerability of tirabrutinib in adults with relapsed/refractory B-cell malignancy who have tolerated and achieved stable disease or improved with tirabrutinib treatment while enrolled in a prior (parent study) tirabrutinib study (NCT01659255). The dosing regimen will be based on the prior dosing regimen from the parent study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (AEs) |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| PRIMARY Percentage of Participants Who Experienced Treatment-Emergent Marked Laboratory Abnormalities |
100.0; 100.0; 66.7; 71.4; 100.0; 100.0 | — |
| SECONDARY Overall Response Rate (ORR) |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Duration of Response (DOR) |
NA; 27.0; 57.7; NA; NA; 33.6 | — |
| SECONDARY Progression-free Survival (PFS) |
NA; 44.0; 59.5; NA; NA; 35.4 | — |
| SECONDARY Overall Survival (OS) |
NA; NA; NA; NA; NA; NA | — |
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.
Data sourced from ClinicalTrials.gov (NCT02457559). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.