RecruitingInterventionalPhase 1

A Study to Assess the Effect of Venetoclax on the Pharmacokinetics of Ethinyl Estradiol/Levonorgestrel in Female Subjects With Hematologic Malignancies

NCT ID: NCT03557619Sponsor: AbbVieLast updated: 2024-08-29

Summary

A study to assess the effect of multiple doses of venetoclax on the pharmacokinetics of ethinyl estradiol and levonorgestrel in female participants with different hematological malignancies. Upon completion of this study, participants receiving clinical benefit in the opinion of the investigator and without any clinically significant evidence of disease progression with no access to venetoclax (not approved for the treated indication) may continue receiving venetoclax at the discretion of the investigator in a separate extension study.

Arms & interventions

DrugVenetoclax
tablet; oral
Drugethinyl estradiol/levonorgestrel
tablet; oral

Outcome measures

Primary

Tmax of Venetoclax
Time to maximum plasma concentration (Tmax) of Venetoclax.
Time frame: Up to approximately 59 days after initial study drug dose
Tmax of (ethinyl estradiol) EE/Levonorgestrel
Time to maximum plasma concentration (Tmax) of EE/Levonorgestrel
Time frame: Up to approximately 59 days after initial study drug dose
Cmax of Venetoclax
Maximum plasma concentration (Cmax) of Venetoclax
Time frame: Up to approximately 59 days after initial study drug dose
Cmax of EE/Levonorgestrel
Maximum plasma concentration (Cmax) of EE/Levonorgestrel
Time frame: Up to approximately 59 days after initial study drug dose
t1/2 of Venetoclax
Terminal phase elimination half-life (t1/2) of Venetoclax.
Time frame: Up to approximately 59 days after initial study drug dose
t1/2 of EE/Levonorgestrel
Terminal phase elimination half-life (t1/2) of EE/Levonorgestrel
Time frame: Up to approximately 59 days after initial study drug dose
AUCt of Venetoclax
Area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt) of Venetoclax
Time frame: Up to approximately 59 days after initial study drug dose
AUCt of EE/Levonorgestrel
Area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt) of EE/Levonorgestrel
Time frame: Up to approximately 59 days after initial study drug dose
AUCinf of EE/Levonorgestrel
AUC from time 0 extrapolated to infinite time (AUCinf) of EE/Levonorgestrel.
Time frame: Up to approximately 59 days after initial study drug dose

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No

Inclusion Criteria: * Participant must have relapsed or refractory non-Hodgkin's lymphoma (NHL). * Participant must have histologically documented diagnosis of one of the following NHL subtypes: diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), lymphoplasmacytic lymphoma (LPL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), T-cell prolymphocytic lymphoma (T-PLL), Waldenström's macroglobulinemia (WM) * Has an Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to two. * Must have adequate bone marrow, coagulation, renal and hepatic function as described in the protocol. * A female of non-childbearing potential as described in the protocol. Exclusion Criteria: * History of currently active, clinically significant cardiovascular disease. * If the participant has had prior stem cell transplantation, it must have been more than 100 days prior to start of study drug, with no graft versus host disease, and no immunosuppression therapy. * evidence of transformation of the lymphoma immediately prior to study entry. * Evidence of central nervous system involvement by lymphoma.

Study locations (3)

Duplicate_Henry Ford Health System /ID# 209090

Detroit, Michigan, 48202

Completed

Dartmouth-Hitchcock Medical Center /ID# 169097

Lebanon, New Hampshire, 03756

Completed

Gabrail Cancer Center Research /ID# 207039

Canton, Ohio, 44718

Completed