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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03557619
Recruitment Status : Recruiting
First Posted : June 15, 2018
Last Update Posted : April 16, 2020
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 participants with different hematological malignancies.

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

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
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 : August 28, 2020
Estimated Primary Completion Date : July 4, 2021
Estimated Study Completion Date : September 1, 2021


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:
  • ABT-199
  • GDC-0199
  • Venclexta

Drug: ethinyl estradiol/levonorgestrel
tablet; oral
Other Name: Levora




Primary Outcome Measures :
  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.



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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:

  • 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.

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, Michigan
Henry Ford Health System /ID# 209090 Recruiting
Detroit, Michigan, United States, 48202
United States, New Hampshire
Dartmouth-Hitchcock Med Ctr /ID# 169097 Not yet recruiting
Lebanon, New Hampshire, United States, 03756
United States, Ohio
Gabrail Cancer Center Research /ID# 207039 Recruiting
Canton, Ohio, United States, 44718
Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03557619    
Other Study ID Numbers: M16-185
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Hematologic Neoplasms
Neoplasms
Neoplasms by Site
Hematologic Diseases
Venetoclax
Levonorgestrel
Ethinyl estradiol, levonorgestrel drug combination
Estradiol
Ethinyl Estradiol
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Antineoplastic Agents
Contraceptives, Oral, Combined