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

Hematologic Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03557619
• Other study ID #: M16-185
• Status: Recruiting
• Phase: Phase 1
• Start date: July 30, 2019
• Est. completion date: September 4, 2024

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: September 4, 2024
• Est. primary completion date: September 4, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Malignancies
• Hematologic Neoplasms
• Neoplasms

Intervention

Drug:
• Venetoclax
tablet; oral
• ethinyl estradiol/levonorgestrel
tablet; oral

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Centre-East Melbourne /ID# 225247	East Melbourne	Victoria
United States	Gabrail Cancer Center Research /ID# 207039	Canton	Ohio
United States	Henry Ford Health System /ID# 209090	Detroit	Michigan
United States	Dartmouth-Hitchcock Medical Center /ID# 169097	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

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

External Links

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