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

November 14, 2023 updated by: AbbVie

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 1

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Recruiting
        • Peter MacCallum Cancer Centre-East Melbourne /ID# 225247
  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Completed
        • Henry Ford Health System /ID# 209090
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth-Hitchcock Medical Center /ID# 169097
    • Ohio
      • Canton, Ohio, United States, 44718
        • Completed
        • Gabrail Cancer Center Research /ID# 207039

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Venclexta
  • ABT-199
  • GDC-0199
Drug: ethinyl estradiol/levonorgestrel
tablet; oral
Other Names:
  • Levora

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tmax of Venetoclax
Time Frame: Up to approximately 59 days after initial study drug dose
Time to maximum plasma concentration (Tmax) of Venetoclax.
Up to approximately 59 days after initial study drug dose
Tmax of (ethinyl estradiol) EE/Levonorgestrel
Time Frame: Up to approximately 59 days after initial study drug dose
Time to maximum plasma concentration (Tmax) of EE/Levonorgestrel
Up to approximately 59 days after initial study drug dose
Cmax of Venetoclax
Time Frame: Up to approximately 59 days after initial study drug dose
Maximum plasma concentration (Cmax) of Venetoclax
Up to approximately 59 days after initial study drug dose
Cmax of EE/Levonorgestrel
Time Frame: Up to approximately 59 days after initial study drug dose
Maximum plasma concentration (Cmax) of EE/Levonorgestrel
Up to approximately 59 days after initial study drug dose
t1/2 of Venetoclax
Time Frame: Up to approximately 59 days after initial study drug dose
Terminal phase elimination half-life (t1/2) of Venetoclax.
Up to approximately 59 days after initial study drug dose
t1/2 of EE/Levonorgestrel
Time Frame: Up to approximately 59 days after initial study drug dose
Terminal phase elimination half-life (t1/2) of EE/Levonorgestrel
Up to approximately 59 days after initial study drug dose
AUCt of Venetoclax
Time Frame: 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
Up to approximately 59 days after initial study drug dose
AUCt of EE/Levonorgestrel
Time Frame: 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
Up to approximately 59 days after initial study drug dose
AUCinf of EE/Levonorgestrel
Time Frame: Up to approximately 59 days after initial study drug dose
AUC from time 0 extrapolated to infinite time (AUCinf) of EE/Levonorgestrel.
Up to approximately 59 days after initial study drug dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2019

Primary Completion (Estimated)

March 2, 2024

Study Completion (Estimated)

March 2, 2024

Study Registration Dates

First Submitted

June 5, 2018

First Submitted That Met QC Criteria

June 14, 2018

First Posted (Actual)

June 15, 2018

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 14, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M16-185

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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