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

Primary Purpose

Hematologic Malignancies

Status

Recruiting

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Venetoclax

ethinyl estradiol/levonorgestrel

About this trial

This is an interventional basic science trial for Hematologic Malignancies focused on measuring Cancer, Hematologic Malignancies, venetoclax, ethinyl estradiol, relapsed or refractory non-Hodgkin's lymphoma, non-Hodgkin's lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

Henry Ford Health System /ID# 209090
Dartmouth-Hitchcock Medical Center /ID# 169097Recruiting
Gabrail Cancer Center Research /ID# 207039Recruiting
Peter MacCallum Cancer Centre-East Melbourne /ID# 225247Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ethinyl estradiol/Levonorgestrel and Venetoclax

Arm Description

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.

Outcomes

Primary Outcome Measures

Tmax of Venetoclax

Time to maximum plasma concentration (Tmax) of Venetoclax.

Tmax of (ethinyl estradiol) EE/Levonorgestrel

Time to maximum plasma concentration (Tmax) of EE/Levonorgestrel

Cmax of Venetoclax

Maximum plasma concentration (Cmax) of Venetoclax

Cmax of EE/Levonorgestrel

Maximum plasma concentration (Cmax) of EE/Levonorgestrel

t1/2 of Venetoclax

Terminal phase elimination half-life (t1/2) of Venetoclax.

t1/2 of EE/Levonorgestrel

Terminal phase elimination half-life (t1/2) of EE/Levonorgestrel

AUCt of Venetoclax

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

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

AUC from time 0 extrapolated to infinite time (AUCinf) of EE/Levonorgestrel.

Secondary Outcome Measures

Full Information

NCT ID

NCT03557619

First Posted

June 5, 2018

Last Updated

August 9, 2023

Sponsor

AbbVie

1. Study Identification

Unique Protocol Identification Number

NCT03557619

Brief Title

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

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 30, 2019 (Actual)

Primary Completion Date

March 2, 2024 (Anticipated)

Study Completion Date

March 2, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hematologic Malignancies

Keywords

Cancer, Hematologic Malignancies, venetoclax, ethinyl estradiol, relapsed or refractory non-Hodgkin's lymphoma, non-Hodgkin's lymphoma

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ethinyl estradiol/Levonorgestrel and Venetoclax

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Venetoclax

Other Intervention Name(s)

ABT-199, GDC-0199, Venclexta

Intervention Description

tablet; oral

Intervention Type

Drug

Intervention Name(s)

ethinyl estradiol/levonorgestrel

Other Intervention Name(s)

Levora

Intervention Description

tablet; oral

Primary Outcome Measure Information:

Title

Tmax of Venetoclax

Description

Time to maximum plasma concentration (Tmax) of Venetoclax.

Time Frame