NCT01704963

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2012

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2012

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2015

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

February 5, 2018

Status Verified

January 1, 2018

Enrollment Period

3.2 years

First QC Date

October 9, 2012

Last Update Submit

February 1, 2018

Conditions

Recurrent Mature B-cell Neoplasms

Keywords

Recurrent mature B-cell neoplasmsB-cell malignanciesBruton's Tyrosine Kinase (Btk) InhibitorPCI-32765TumorPharmacokineticsJapanese

Outcome Measures

Primary Outcomes (1)

  • Number of patients with adverse events

    Screening (Day -14) to until 30 days after the last dose

Secondary Outcomes (7)

  • Area under the plasma concentration-time curve from time 0 to the time of the last measurable concentration (AUClast)

    Days 1-2, 8-9, 15, 22 and 29 during Cycle 1 of each cohort

  • Area under the plasma concentration-time curve from time 0 to infinity time (AUC∞)

    Days 1-2, 8-9, 15, 22 and 29 during Cycle 1 of each cohort

  • Maximum plasma concentration (Cmax)

    Days 1-2, 8-9, 15, 22 and 29 during Cycle 1 of each cohort

  • Time to reach maximum plasma concentration (tmax)

    Days 1-2, 8-9, 15, 22 and 29 during Cycle 1 of each cohort

  • Terminal elimination half-life (t1/2)

    Days 1-2, 8-9, 15, 22 and 29 during Cycle 1 of each cohort

  • +2 more secondary outcomes

Study Arms (1)

PCI-32765

EXPERIMENTAL

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.

Drug: PCI-32765

Interventions

PCI-32765DRUG

PCI-32765 will be administered 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 administered before 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.

PCI-32765

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Kyoto, Japan

Location

Unknown Facility

Nagoya, Japan

Location

Unknown Facility

Sendai, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Related Publications (1)

  • Tobinai 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: 26588924RESULT

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

ibrutinib

Study Officials

  • Janssen Pharmaceutical K.K., Japan Clinical Trial

    Janssen Pharmaceutical K.K.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2012

First Posted

October 12, 2012

Study Start

September 12, 2012

Primary Completion

November 20, 2015

Study Completion

February 1, 2017

Last Updated

February 5, 2018

Record last verified: 2018-01

Locations

JP(4)