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

Part of paid clinical trials in Detroit, Michigan.

Sponsor
AbbVie
Study ID
NCT03557619
Phase
PHASE1
Status
Recruiting
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Conditions

  • Hematologic Malignancies

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    tablet; oral
  • ethinyl estradiol/levonorgestrel — DRUG
    tablet; oral

Study Details

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.

Key Dates

Start date
Jul 30, 2019
Status verified
Aug 2024
Primary completion
Mar 21, 2026
Completion
Mar 21, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • 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.

Primary Outcome Measure

Tmax of Venetoclax [ Time Frame: Up to approximately 59 days after initial study drug dose ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Duplicate_Henry Ford Health System /ID# 209090DetroitMichigan48202-
Dartmouth-Hitchcock Medical Center /ID# 169097LebanonNew Hampshire03756-
Gabrail Cancer Center Research /ID# 207039CantonOhio44718-

Find similar trials in Detroit, MI

By research site
Duplicate_Henry Ford Health System· Detroit, MIDartmouth-Hitchcock Medical Center· Lebanon, NHGabrail Cancer Center Research· Canton, OH

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