Clinical trial · Interventional
A Study to Evaluate the Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in Patients With Recurrent Mature B-Cell Neoplasms
A Phase 1 Study of the Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in Subjects With Recurrent Mature B-Cell Neoplasms
NCT01704963CI-TRIAL-00031544completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and tolerability of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in Japanese patients with recurrent mature B-cell neoplasms.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Mature B-cell Neoplasms | Mature B-Cell Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PCI-32765 | Drug | Ibrutinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PCI-32765
- description
- Patients will receive oral doses of PCI-32765 in Cohort 1, Cohort 2 and CLL/SLL Cohort. In Cohort 1, single oral dose of PCI-32765 140 mg and 280 mg will be given before administration of daily oral doses of 420 mg per day for 35 days in Cycle 1 and for 28 days in Cycle 2 and thereafter. In Cohort 2 and CLL/SLL Cohort, PCI-32765 560 mg and 420 mg per day, respectively will be administered daily for 35 days in Cycle 1 and for 28 days in Cycle 2 and thereafter.
- interventionNames
- Drug: PCI-32765
Primary outcomes (1)
- measure
- Number of patients with adverse events
- timeFrame
- Screening (Day -14) to until 30 days after the last dose
Secondary outcomes (7)
- measure
- Area under the plasma concentration-time curve from time 0 to the time of the last measurable concentration (AUClast)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have body weight at least 40 kilogram (kg) * Patients with recurrent mature B-cell neoplasms as defined according to WHO classification, including small lymphocytic lymphoma/ chronic lymphocytic leukemia, mantle cell lymphoma, and follicular lymphoma * Have measurable disease \[for Non-Hodgkin's Lymphoma (NHL) bi-dimensional disease more than or equal to 2 cm diameter in at least one dimension and for chronic lymphocytic leukemia more than or equal to 5000 leukemia cells/cubic mm\] * Have failed more than or equal to 1 previous treatment and no standard therapy is available * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: * Patients with plasma cell neoplasm as defined according to WHO classification * Patients who have received prior allogeneic hematopoietic stem cell transplant * Patients who have received immunotherapy, chemotherapy, radiotherapy or experimental therapy within 4 weeks before first day of study medication * Past history of major surgery within 4 weeks before the first day of study medication * Patients with central nervous system involvement
References
Publications (1)
- RESULTTobinai K, Ogura M, Ishizawa K, Suzuki T, Munakata W, Uchida T, Aoki T, Morishita T, Ushijima Y, Takahara S. Safety and tolerability of ibrutinib monotherapy in Japanese patients with relapsed/refractory B cell malignancies. Int J Hematol. 2016 Jan;103(1):86-94. doi: 10.1007/s12185-015-1900-3. Epub 2015 Nov 20. PMID 26588924