NCT01704963 is a Phase 1 clinical trial of PCI-32765 in Recurrent Mature B-cell Neoplasms, sponsored by Janssen Pharmaceutical K.K..

Who is sponsoring NCT01704963?

NCT01704963 is sponsored by Janssen Pharmaceutical K.K..

What drugs are being tested in NCT01704963?

Interventions in NCT01704963: PCI-32765.

What condition does NCT01704963 study?

NCT01704963 studies Recurrent Mature B-cell Neoplasms.

Is NCT01704963 still recruiting?

NCT01704963 is currently completed. Last updated 5 February 2018.

Last reviewed 2018-02-05 · How we verify

NCT01704963

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Evaluate the Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in Patients With Recurrent Mature B-Cell Neoplasms

Completed Phase 1 Last updated 5 February 2018

What this trial tests

Phase 1 trial testing PCI-32765 in Recurrent Mature B-cell Neoplasms in 15 participants. Completed in 1 February 2017.

Timeline

12 September 2012

Primary endpoint
20 November 2015

1 February 2017

Quick facts

Lead sponsor	Janssen Pharmaceutical K.K.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	12 September 2012
Primary completion	20 November 2015
Estimated completion	1 February 2017
Sites	4 locations across Japan

Drugs / interventions tested

PCI-32765

Conditions studied

Recurrent Mature B-cell Neoplasms — all drugs for Recurrent Mature B-cell Neoplasms →

Sponsor

Janssen Pharmaceutical K.K. — full company profile →

Who can join

20 and older, any sex, with Recurrent Mature B-cell Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Regulation of B-Cell Receptor Signaling and Its Therapeutic Relevance in Aggressive B-Cell Lymphomas.
Profitós-Pelejà N, Santos JC, Marín-Niebla A, Roué G, et al · · 2022 · cited 33× · PMID 35205606 · DOI 10.3390/cancers14040860
Safety and tolerability of ibrutinib monotherapy in Japanese patients with relapsed/refractory B cell malignancies.
Tobinai K, Ogura M, Ishizawa K, Suzuki T, et al · · 2016 · cited 25× · PMID 26588924 · DOI 10.1007/s12185-015-1900-3

Verify or expand the search:

Other trials of PCI-32765

Trials testing the same drug.

NCT01752426 — Pilot Study to Determine Effects of the Btk Inhibitor PCI-32765 on Leukemia Cell Kinetics and Trafficking, Using Heavy W · Phase 1, PHASE2 · completed
NCT01520519 — Phase 2 Study of the Combination of Bruton's Tyrosine Kinase Inhibitor PCI-32765 and Rituximab in High-Risk Chronic Lymp · Phase 2 · completed

Other Janssen Pharmaceutical K.K. trials

Trials by the same sponsor.

NCT06295692 — A Study of JNJ-77242113 for the Treatment of Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis · Phase 3 · active not recruiting
NCT05926583 — A Study of AAV5-hRKp.RPGR for the Treatment of Japanese Participants With X-linked Retinitis Pigmentosa · Phase 3 · active not recruiting
NCT05567185 — A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer · Phase 1 · active not recruiting
NCT05167825 — A Study of Macitentan in Japanese Pediatric Participants With Pulmonary Arterial Hypertension · Phase 3 · completed
NCT05242432 — A Study of Adenovirus Serotype 26.Respiratory Syncytial Virus.Pre-Fusion F (Ad26.RSV.preF)-Based Vaccine for Prevention · Phase 3 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01704963 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Janssen Pharmaceutical K.K.
Last refreshed: 5 February 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01704963.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing