A Phase 1 interventional study of Venetoclax and ethinyl estradiol/levonorgestrel in Hematologic Malignancies, sponsored by AbbVie. Recruiting at 4 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-29.
Sponsored by AbbVie · Phase 1, Interventional, and Basic science
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 12 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ethinyl estradiol/levonorgestrel is administered on Period 1 Day 1 and then again on Period 3 Day 1. Venetoclax is administered on Period 2 Day 1 and then daily thereafter.
Drug: Venetoclax · Drug: ethinyl estradiol/levonorgestrel
tablet; oral
Also known as: ABT-199, GDC-0199, Venclexta
tablet; oral
Also known as: Levora
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
Plan to share: No
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