Clinical trial · Interventional
Interaction Study of Ibrutinib and Cytochrome P450 (CYP) 3A Inhibitors in Participants With B-cell Malignancy
A Drug-drug Interaction Study of Ibrutinib With Moderate and Strong CYP3A Inhibitors in Patients With B-cell Malignancy
NCT02381080CI-TRIAL-00028265completedPhase 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 assess the effect of a moderate Cytochrome P450 (CYP) 3A inhibitor (erythromycin) and a strong CYP3A inhibitor (voriconazole) on the steady-state pharmacokinetics (PK \[the study of the way a drug enters and leaves the blood and tissues over time\]) of repeated oral doses of ibrutinib in participants with B-cell malignancy (cancer or other progressively enlarging and spreading tumors).
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 |
|---|---|---|---|
| B-Cell Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erythromycin | Drug | — | UNRESOLVED |
| Ibrutinib | Drug | Ibrutinib | ALIAS |
| Voriconazole | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part 1: Ibrutinib+Erythromycin+Voriconazole
- description
- Participants will receive oral treatment in six, 28-days cycles. In Cycle 1, participants will take ibrutinib 560 milligram (mg) (4\*140 mg capsules) once daily (QD) from Days 1- 4; on Days 5-11 ibrutinib 140 mg capsule QD in combination with erythromycin 500 mg tablet 3 times daily (TID); on Days 12-13 ibrutinib 140 mg capsule QD; on Days 14-18 ibrutinib 560 mg (4\*140 mg capsules) QD; on Days 19-25 ibrutinib 140 mg capsule QD in combination with voriconazole 200 mg tablet twice daily (BD); on Days 26-27 ibrutinib 140 mg capsule orally QD; and on Day 28 and in subsequent treatment Cycles (2-6) participants will continue oral treatment with ibrutinib 420 mg or 560 mg QD (depending on the subtype of B-cell malignancy).
- interventionNames
- Drug: Ibrutinib
- Drug: Erythromycin
- Drug: Voriconazole
- type
- EXPERIMENTAL
- label
- Part 2: Ibrutinib+ Erythromycin+Voriconazole
- description
- Participants will receive oral treatment in six, 28-days cycles. In Cycle 1, participants will take ibrutinib 560 mg (4\*140 mg capsules) QD from Days 1- 4; on Days 5-18 ibrutinib 560 mg (4\*140 mg capsules) QD in combination with either erythromycin 500 mg tablet TID (Group 1) or voriconazole 200 mg tablet BD (Group 2); on Day 19 and in subsequent treatment Cycles (2-6) participants will continue oral treatment with ibrutinib 420 mg or 560 mg QD (depending on the subtype of B-cell malignancy).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL), Marginal Zone Lymphoma (MZL), Mantle Cell Lymphoma (MCL), Follicular Lymphoma (FL), or Waldenstrom's Macroglobulinemia (WM) * Relapsed or refractory disease after at least 1 prior line of systemic therapy (participants with FL or MZL must have failed anti-CD20 monoclonal antibody containing chemotherapy regimen) * Eastern Cooperative Oncology Group Performance Status score of 0 or 1 * Hematology values within the following limits: a) Absolute neutrophil count (ANC) greater than and equal to (\>=) 1.0\*10\^9 per liter (L); b) Platelets \>=50\*10\^9/L without transfusion support within 7 days; c) Hemoglobin \>=8 gram per deciliter (g/dL) without transfusion support within 7 days; d) Prothrombin time /International normalized ratio (PT/INR) less than equal to (\<=) 1.5\*Upper Limit of Normal (ULN) and activated partial thromboplastin time (aPTT) \<=1.5\*ULN * Biochemical values within the following limits: a) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<=3.0\*ULN; b) Total bilirubin \<=1.5\*ULN (unless due to Gilbert's syndrome); c) Serum creatinine \<=1.5\*ULN or a calculated creatinine clearance of \>=50 milliliter per minute per 1.73 square meter Exclusion Criteria: * Major surgery within 4 weeks of the first dose of ibrutinib * Diagnosed or treated for malignancy other than the indication under study except for: a) Adequately treated non-melanoma skin cancer or lentigo maligna, curatively treated in-situ cancer without evidence of disease; b) Malignancy treated with curative intent and with no known active disease present for \>=3 years before the first dose of ibrutinib * History of stroke or intracranial hemorrhage within 6 months prior to the first dose of ibrutinib * History of galactose intolerance * Requires anticoagulation with warfarin or equivalent vitamin K antagonists (for example, phenprocoumon)
References
Publications (0)
Data not yet available
No reference posted for this study.