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NCT Number: NCT03557619

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

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Key information

Conditions

Hematologic Malignancies Disease Attributes Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Peter MacCallum Cancer Centre-East Melbourne /ID# 225247, East Melbourne, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Venetoclax

Drug

tablet; oral

Other names: ABT-199, GDC-0199, Venclexta

Ethinyl estradiol/levonorgestrel

Drug

tablet; oral

Other names: Levora

Primary outcomes

  1. Tmax of Venetoclax

    Time frame: Up to approximately 59 days after initial study drug dose

    Time to maximum plasma concentration (Tmax) of Venetoclax.

  2. 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

  3. Cmax of Venetoclax

    Time frame: Up to approximately 59 days after initial study drug dose

    Maximum plasma concentration (Cmax) of Venetoclax

  4. Cmax of EE/Levonorgestrel

    Time frame: Up to approximately 59 days after initial study drug dose

    Maximum plasma concentration (Cmax) of EE/Levonorgestrel

  5. 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.

  6. 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

  7. 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

  8. 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

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jun 15, 2018
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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