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Trial record 33 of 182 for:    Venetoclax

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 : Not yet recruiting
First Posted : June 15, 2018
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

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.

Condition or disease Intervention/treatment Phase
Hematologic Malignancies Drug: Venetoclax Drug: ethinyl estradiol/levonorgestrel Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Study to Assess the Effect of Venetoclax on the Pharmacokinetics of Ethinyl Estradiol/Levonorgestrel in Female Subjects With Hematologic Malignancies
Estimated Study Start Date : April 5, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : February 17, 2021


Arm Intervention/treatment
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
Drug: Venetoclax
tablet; oral
Other Names:
  • ABT-199
  • GDC-0199

Drug: ethinyl estradiol/levonorgestrel
oral
Other Name: Levora




Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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

  5. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has relapsed or refractory non-Hodgkin's lymphoma (Mantle Cell Lymphoma [MCL], Waldenström's macroglobulinemia [WM] or Chronic Lymphocytic Leukemia/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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03557619


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com

Locations
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United States, California
UC Davis Comp Cancer Ctr /ID# 205869 Not yet recruiting
Sacramento, California, United States, 95817
United States, Illinois
University of Chicago /ID# 209171 Not yet recruiting
Chicago, Illinois, United States, 60637
United States, Michigan
Henry Ford Health System /ID# 209090 Not yet recruiting
Detroit, Michigan, United States, 48202
United States, New Hampshire
Dartmouth-Hitchock Med Ctr /ID# 169097 Not yet recruiting
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03557619     History of Changes
Other Study ID Numbers: M16-185
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Keywords provided by AbbVie:
Cancer
Hematologic Malignancies, venetoclax
ethinyl estradiol
relapsed or refractory non-Hodgkin's lymphoma
non-Hodgkin's lymphoma

Additional relevant MeSH terms:
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Venetoclax
Neoplasms
Estradiol
Polyestradiol phosphate
Ethinyl Estradiol
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Levonorgestrel
Ethinyl estradiol, levonorgestrel drug combination
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Antineoplastic Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptives, Oral, Combined