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

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ClinicalTrials.gov Identifier: NCT03557619
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE June 5, 2018
First Posted Date  ICMJE June 15, 2018
Last Update Posted Date August 13, 2019
Actual Study Start Date  ICMJE July 30, 2019
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2018)
  • Tmax of (ethinyl estradiol) EE/Levonorgestrel and Venetoclax [ Time Frame: Up to approximately 59 days after initial study drug dose ]
    Time to maximum plasma concentration (Tmax) of EE/Levonorgestrel and Venetoclax.
  • Cmax of EE/Levonorgestrel and Venetoclax [ Time Frame: Up to approximately 59 days after initial study drug dose ]
    Maximum plasma concentration (Cmax) of EE/Levonorgestrel and Venetoclax
  • t1/2 of EE/Levonorgestrel and Venetoclax [ Time Frame: Up to approximately 59 days after initial study drug dose ]
    Terminal phase elimination half-life (t1/2) of EE/Levonorgestrel and Venetoclax.
  • AUCt of EE/Levonorgestrel and 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 EE/Levonorgestrel and Venetoclax
  • 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/levonorgest.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Effect of Venetoclax on Ethinyl Estradiol and Levonorgestrel in Female Subjects With Different Hematological Malignancies
Official Title  ICMJE A Study to Assess the Effect of Venetoclax on the Pharmacokinetics of Ethinyl Estradiol/Levonorgestrel in Female Subjects With Hematologic Malignancies
Brief Summary A study to assess the effect of multiple doses of venetoclax on the pharmacokinetics of ethinyl estradiol and levonorgestrel in female subjects with different hematological malignancies.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Hematologic Malignancies
Intervention  ICMJE
  • Drug: Venetoclax
    tablet; oral
    Other Names:
    • ABT-199
    • GDC-0199
  • Drug: ethinyl estradiol/levonorgestrel
    oral
    Other Name: Levora
Study Arms  ICMJE Experimental: Ethinyl estradiol/Levonorgestrel and Venetoclax
Ethinyl estradiol/Levonorgestrel administered once daily (QD) on Period 1 Day 1 and QD on Period 3 Day 1. Daily doses of venetoclax is administered for at least 54 days, starting on Period 2 Day 1 and for 6 days in Period 3
Interventions:
  • Drug: Venetoclax
  • Drug: ethinyl estradiol/levonorgestrel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 14, 2018)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 15, 2021
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Has relapsed or refractory non-Hodgkin's lymphoma (Mantle Cell Lymphoma [MCL], Waldenström's macroglobulinemia [WM] or Chronic Lymphocytic Leukemialeukemia/small lymphocytic lymphoma [CLL/SLL]) as described in the protocol.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1.
  • Must have adequate bone marrow (independent of growth factor support per local laboratory reference range), coagulation, renal and hepatic function as described in the protocol.
  • Female who is not pregnant, breastfeeding, or considering becoming pregnant during the course of this study or for at least 30 days after the last dose of venetoclax.
  • A female of childbearing potential must avoid pregnancy while taking study drug(s) and for at least 30 days after the last dose of study drug. Females must commit to one of the methods of birth control described in the protocol.

Exclusion Criteria:

  • Evidence of left ventricular ejection fraction (LVEF) below the lower limit of institutional normal.
  • History of currently active, clinically significant cardiovascular disease.
  • History of prolymphocytic leukemia.
  • Prior allogeneic stem cell transplantation.
  • History or presence of other malignancies whose risk is higher than the concomitant CLL/SLL or MCL or WM.
  • Evidence of central nervous system involvement by CLL/SLL or lymphoma.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03557619
Other Study ID Numbers  ICMJE M16-185
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP