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. 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.
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
Interventions
| Drug | Synonyms | Arms |
|---|
| Venetoclax | ABT-199, GDC-0199, Venclexta | Ethinyl estradiol/Levonorgestrel and Venetoclax |
| ethinyl estradiol/levonorgestrel | Levora | Ethinyl 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. 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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Ethinyl estradiol/Levonorgestrel and Venetoclax | Experimental | 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. | - 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
July 21, 2021
