Clinical trial NCT03557619: A Study to Assess the Effect of Venetoclax on Ethinyl Estradiol and Levonorgestrel in Female Participants With Different Hematological Malignancies
Official title: A Study to Assess the Effect of Venetoclax on the Pharmacokinetics of Ethinyl Estradiol/Levonorgestrel in Female Subjects With Hematologic Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hematologic Malignancies
Keywords: Cancer
Hematologic Malignancies, venetoclax
ethinyl estradiol
relapsed or refractory non-Hodgkin's lymphoma
non-Hodgkin's lymphoma
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-06-15
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Tmax of Venetoclax
timeFrame: Up to approximately 59 days after initial study drug dose
measure: Tmax of (ethinyl estradiol) EE/Levonorgestrel
timeFrame: Up to approximately 59 days after initial study drug dose
measure: Cmax of Venetoclax
timeFrame: Up to approximately 59 days after initial study drug dose
measure: Cmax of EE/Levonorgestrel
timeFrame: Up to approximately 59 days after initial study drug dose
measure: t1/2 of Venetoclax
timeFrame: Up to approximately 59 days after initial study drug dose
measure: t1/2 of EE/Levonorgestrel
timeFrame: Up to approximately 59 days after initial study drug dose
measure: AUCt of Venetoclax
timeFrame: Up to approximately 59 days after initial study drug dose
measure: AUCt of EE/Levonorgestrel
timeFrame: Up to approximately 59 days after initial study drug dose
measure: AUCinf of EE/Levonorgestrel
timeFrame: Up to approximately 59 days after initial study drug dose
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Duplicate_Henry Ford Health System /ID# 209090
state: Michigan
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center /ID# 169097
state: New Hampshire
city: Canton
country: United States
facility: Gabrail Cancer Center Research /ID# 207039
state: Ohio
city: East Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre-East Melbourne /ID# 225247
state: Victoria
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: