Status:
COMPLETED
A Study to Evaluate the Effect of Ibrutinib on the Pharmacokinetics of Oral Contraceptives, CYP2B6, and CYP3A4 Substrates in Female Participants With B Cell Malignancy
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Leukemia, Lymphocytic, Chronic, B-Cell
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
The main purpose of this study is to evaluate the effects of repeat dosing of ibrutinib on the single-dose pharmacokinetics (PK) of oral contraceptives (OC - ethinylestradiol \[EE\] and levonorgestrel...
Detailed Description
This is a multicenter study of ibrutinib (first-in-class, potent, covalently-binding inhibitor of Bruton's tyrosine kinase \[BTK\]) in female participants with B cell malignancy. The study consists of...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), or Waldenstrom's macroglobulinemia (WM)
- Participants with MCL must have relapsed or refractory disease after at least 1 prior line of systemic therapy
- Participants with MZL must have failed an anti-cluster of differentiation (CD)20 monoclonal antibody-based therapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Adequate hematologic, hepatic, and renal functions
- Before the first dose of oral contraceptive (OC), a woman must be either:
- Not of childbearing potential: postmenopausal (greater than \[\>\]45 years of age with amenorrhea for at least 12 months and a serum follicle stimulating hormone level \>40 international unit per Liter \[IU/L\] or milli international unit per milli Liter \[mIU/mL\]); permanently sterilized
- Of childbearing potential and practicing a highly effective non-hormonal method of birth control
- Women of childbearing potential must have a negative serum (Beta-human chorionic gonadotropin \[Beta-hCG\]) or urine pregnancy test at screening
Exclusion
- Major surgery planned within 2 weeks of the first dose of ibrutinib or during study participation up to Cycle 2 Day 1
- History of other malignancies, except:
- Malignancy treated with curative intent and with no known active disease present for greater than or equal to (\>=)3 years before the first dose of ibrutinib and felt to be at low risk for recurrence by treating physician
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated in-situ cancer without evidence of disease
- History of breast or endometrial cancer
- Prior treatment/exposure with ibrutinib or other Bruton's tyrosine kinase (BTK) inhibitor
- Requires ongoing anticoagulation treatment with warfarin or equivalent vitamin K antagonists (for example, phenprocoumon)
- Requires therapies that must be discontinued or substituted 7 days prior to Study Day 1, or must be temporally interrupted during the course of the study, including the following:
- Medications known to induce or inhibit drug metabolizing enzymes (CYP3A4 and CYP2B6)
- Medication which are not allowed to be used in combination with EE, LN, bupropion, or midazolam
Key Trial Info
Start Date :
October 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2018
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03301207
Start Date
October 20 2017
End Date
December 4 2018
Last Update
December 5 2019
Active Locations (4)
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1
Pratia MCM Krakow
Krakow, Poland, 30-510
2
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw, Poland, 50-367
3
Hosp. Univ. Fund. Jimenez Diaz
Madrid, Spain, 28040
4
Clinica Univ. de Navarra
Pamplona, Spain, 31008