Areas of Study

We are committed to fully exploring the potential of IMBRUVICA® (ibrutinib)

Conducting clinical trials is a vital step in the process of delivering safe and effective therapies to the people who need them most. In less than a decade, we have helped treat more than 120,000 patients impacted by life-threatening illnesses in clinical practice and clinical trials around the world.

We have one of the most robust clinical oncology development programs for a single molecule in the industry, with more than 130 ongoing clinical trials. There are approximately 30 ongoing company-sponsored trials, 14 of which are in Phase 3, and more than 100 investigator-sponsored trials and external collaborations that are active worldwide.

Ibrutinib: Bruton's tyrosine kinase (BTK) inhibitor

Chronic Lymphocytic Leukemia/
Small Lymphocytic Lymphoma
(CLL/SLL)

All Lines of Treatment 

  • Approved

PCYC–1102

The purpose of this study is to establish the safety and efficacy of orally administered PCI-32765 in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma.

Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT01105247 (Accessed November 3, 2017)

Chronic Lymphocytic Leukemia/
Small Lymphocytic Lymphoma
(CLL/SLL)

Previously Treated Patients

  • Approved

PCYC–1112, RESONATE

The purpose of the study is to evaluate whether treatment with ibrutinib as a monotherapy results in a clinically significant improvement in progression free survival (PFS) as compared to treatment with ofatumumab in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).

Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT01578707  (Accessed November 3, 2017)

Chronic Lymphocytic Leukemia/ 
Small Lymphocytic Lymphoma 
(CLL/SLL)

First Line Treatment
Elderly and/or Unfit Patients

  • Approved

PCYC–1115 RESONATE-2, PCYC-1116

A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 versus Chlorambucil in Patients 65 Years or Older with Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT01724346  (Accessed November 3, 2017)

Chronic Lymphocytic Leukemia/
Small Lymphocytic Lymphoma
(CLL/SLL)

Previously Treated Patients

  • Approved

CLL3001, HELIOS

The purpose of this study is to examine the safety and efficacy of Ibrutinib administered in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT01611090 (Accessed November 3, 2017)

Chronic Lymphocytic Leukemia/
Small Lymphocytic Lymphoma
(CLL/SLL)

First Line Treatment 
Young/Fit Patients

  • Phase 3

PCYC–1126E/ECOG

This randomized phase III trial studies ibrutinib and rituximab to see how well they work compared to fludarabine phosphate, cyclophosphamide, and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.

Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT02048813  (Accessed November 3, 2017)

Chronic Lymphocytic Leukemia/
Small Lymphocytic Lymphoma
(CLL/SLL)

First Line Treatment
Elderly and/or Unfit Patients

  • Phase 3

PCYC–1130, iLLUMINATE

An open-label, multi-center randomized, phase 3 study of ibrutinib combined with obinutuzumab versus chlorambucil in combination with obinutuzumab in subjects with treatment-naïve Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.

Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT02264574 (Accessed November 3, 2017)

Chronic Lymphocytic Leukemia/
Small Lymphocytic Lymphoma
(CLL/SLL)

First Line Treatment
Elderly and/or Unfit Patients

  • Phase 3

CLL3011, GLOW

A Randomized, Open-label, Phase 3 Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Subjects With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL).

Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/record/NCT03462719 (Accessed July, 2018)

Chronic Lymphocytic Leukemia/
Small Lymphocytic Lymphoma
(CLL/SLL)

First Line Treatment
Young/Fit Patients

  • Phase 2

PCYC–1142, CAPTIVATE

This study is to determine the clinical minimum residual disease (MRD) response with the combination of ibrutinib plus venetoclax in subjects with treatment-naive chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT02910583 (Access November 3, 2017)

Mantle Cell Lymphoma
(MCL)

Previously Treated Patients

  • Approved

PCYC–1104

The primary objective of this study was to evaluate the efficacy of ibrutinib in participants with relapsed or refractory MCL. The secondary objective was to evaluate the safety of a fixed daily dosing regimen (560 mg daily) of PCI-32765 in this population.

Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT01236391 (Accessed November 3, 2017)

Mantle Cell Lymphoma
(MCL)

First Line Treatment

  • Phase 3

MCL3002, SHINE

The purpose of this study is to evaluate the efficacy and safety of ibrutinib given in combination with bendamustine and rituximab in patients 65 years of age or older with newly diagnosed mantle cell lymphoma.

Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT01776840  (Accessed November 3, 2017)

Mantle Cell Lymphoma
(MCL)

Previously Treated Patients

  • Phase 3

PCYC–1143, SYMPATICO

This Phase 3 multinational, randomized, double-blind study is designed to compare the efficacy and safety of the combination of ibrutinib and venetoclax vs. ibrutinib and placebo in subjects with MCL.

Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT03112174  (Accessed November 3, 2017)

Waldenström's Macroglobulinemia
(WM)

Previously Treated Patients

  • Approved

PCYC–1118e

In this research study, the investigators are testing the safety and efficacy of PCI-32765 as a treatment option for relapsed or refractory Waldenstrom's Macroglobulinemia.

Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT01614821  (Accessed November 3, 2017)

Waldenström's Macroglobulinemia
(WM)

All Lines of Treatment

  • Approved

PCYC–1127, iNNOVATE

The purpose of this study is to evaluate the safety and efficacy of Ibrutinib in combination with Rituximab in subjects with Waldenström's Macroglobulinemia.

Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT02165397  (Accessed November 3, 2017)

Marginal Zone Lymphoma
(MZL)

Previously Treated Patients

  • Approved

PCYC–1121

Phase 2, open-label, non-randomized, monotherapy study to evaluate the safety and efficacy of ibrutinib in subjects with relapsed/refractory Marginal Zone Lymphoma (MZL).

Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT01980628 (Accessed November 3, 2017)

Follicular Lymphoma
(FL)

First Line Treatment 
Elderly and/or Unfit Patients

  • Phase 3

PCYC–1141, PERSPECTIVE

The purpose of this study is to evaluate whether the addition of ibrutinib will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment naïve subjects with follicular lymphoma.

Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT02947347 (Accessed November 3, 2017)

Follicular Lymphoma
(FL)

Previously Treated Patients 

  • Phase 3

FLR3001, SELENE

The purpose of this study is to evaluate the efficacy and safety of ibrutinib administered in combination with either bendamustine and rituximab (BR) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in adult participants with previously treated indolent Non-Hodgkin lymphoma.

Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT01974440 (Accessed November 3, 2017)

Diffuse Large B-Cell Lymphoma
(DLBCL)

Previously Treated Patients

  • Phase 1b/2

PCYC–1123

This Phase 1b/2 study is designed to assess the safety and efficacy of ibrutinib in combination with lenalidomide and rituximab in subjects with relapsed/refractory Diffuse Large B-Cell Lymphoma (DLBCL) not eligible for transplant.

Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT02077166  >(Accessed November 3, 2017)

Chronic Graft-versus-Host Disease
(cGVHD)

Previously Treated Patients

  • Approved

PCYC–1129

The purpose of this study is to assess the safety and clinical efficacy of ibrutinib in subjects with steroid dependent or refractory Chronic Graft Versus Host Disease.

Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT02195869 (Accessed November 3, 2017)

Chronic Graft-versus-Host Disease

First Line Treatment 

  • Phase 3

PCYC–1140, INTEGRATE

To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.

Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT02959944  (Accessed November 3, 2017)

Mature B-Cell Non-Hodgkin Lymphomas 

Previously Treated
Pediatrics  

  • Phase 3

LYM3003, SPARKLE

LYM3003, SPARKLE, is a randomized, open-label, safety and efficacy study of ibrutinib in pediatric and young adult patients with relapsed or refractory mature B-cell non-Hodgkin lymphoma and is set up to be conducted in two parts. In Part 1, the purpose is to evaluate the consistency of pharmacokinetics of ibrutinib in pediatric participants versus/as compared to adults. In Part 2, the purpose is to assess efficacy (event-free survival [EFS]) of ibrutinib in combination with rituximab, ifosfamide, carboplatin and etoposide (RICE) or rituximab, vincristine, ifosfamide, carboplatin and idarubicin (RVICI) background therapy compared to RICE or RVICI background therapy alone.

Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT02703272 (Accessed September, 2018)

Pancreatic Cancer 

First Line Treatment

  • Phase 2/3

PCYC–1137, RESOLVE

This is a phase 2/3 study to evaluate the efficacy of ibrutinib in combination with nab-paclitaxel and gemcitabine for the first line treatment of patients with metastatic pancreatic adenocarcinoma.

Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT02436668  (Accessed November 3, 2017)

Solid Tumor

Previously Treated Patients

  • Phase 1b/2

PCYC–1128

The purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination treatment of ibrutinib with everolimus, paclitaxel, docetaxel, or cetuximab in selected advanced gastrointestinal and genitourinary tumors.

Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT02599324 (Accessed November 3, 2017)