Clinical Trials /

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

NCT03557619

Description:

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.

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
  • Follicular Lymphoma
  • Lymphoplasmacytic Lymphoma
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
  • T-Cell Prolymphocytic Leukemia
  • Waldenstrom Macroglobulinemia
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: M16-185
  • NCT ID: NCT03557619

Conditions

  • Hematologic Malignancies

Interventions

DrugSynonymsArms
VenetoclaxABT-199, GDC-0199, VenclextaEthinyl estradiol/Levonorgestrel and Venetoclax
ethinyl estradiol/levonorgestrelLevoraEthinyl estradiol/Levonorgestrel and Venetoclax

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Ethinyl estradiol/Levonorgestrel and VenetoclaxExperimentalEthinyl 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.
  • Venetoclax
  • ethinyl estradiol/levonorgestrel

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Tmax of Venetoclax
Time Frame:Up to approximately 59 days after initial study drug dose
Safety Issue:
Description:Time to maximum plasma concentration (Tmax) of Venetoclax.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AbbVie

Trial Keywords

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

Last Updated

April 15, 2020