A Study to Assess the Effect of Venetoclax on Ethinyl Estradiol and Levonorgestrel in Female Participants With Different Hematological Malignancies

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03557619

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

2.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hematologic Malignancies	Drug: Venetoclax Drug: ethinyl estradiol/levonorgestrel	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jul 30, 2019

Anticipated Primary Completion Date :

Oct 30, 2022

Anticipated Study Completion Date :

Oct 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ethinyl estradiol/Levonorgestrel and Venetoclax 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 tablet; oral Other Names: ABT-199 GDC-0199 Venclexta Drug: ethinyl estradiol/levonorgestrel tablet; oral Other Names: Levora

Arm

Intervention/Treatment

Experimental: Ethinyl estradiol/Levonorgestrel and Venetoclax

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

tablet; oral

Other Names:

ABT-199

GDC-0199

Venclexta

Drug: ethinyl estradiol/levonorgestrel

tablet; oral

Other Names:

Levora

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Henry Ford Health System /ID# 209090	Detroit	Michigan	United States	48202
2	Dartmouth-Hitchcock Medical Center /ID# 169097	Lebanon	New Hampshire	United States	03756
3	Gabrail Cancer Center Research /ID# 207039	Canton	Ohio	United States	44718
4	The Kinghorn Cancer Centre /ID# 225248	Darlinghurst	New South Wales	Australia	2010
5	Peter MacCallum Cancer Centre-East Melbourne /ID# 225247	East Melbourne	Victoria	Australia	3002