Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venetoclax | Drug | tablet; oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tmax of Venetoclax | Time to maximum plasma concentration (Tmax) of Venetoclax. | Up to approximately 59 days after initial study drug dose |
| Tmax of (ethinyl estradiol) EE/Levonorgestrel | Time to maximum plasma concentration (Tmax) of EE/Levonorgestrel | Up to approximately 59 days after initial study drug dose |
| Cmax of Venetoclax | Maximum plasma concentration (Cmax) of Venetoclax | Up to approximately 59 days after initial study drug dose |
| Cmax of EE/Levonorgestrel | Maximum plasma concentration (Cmax) of EE/Levonorgestrel | Up to approximately 59 days after initial study drug dose |
| t1/2 of Venetoclax | Terminal phase elimination half-life (t1/2) of Venetoclax. | Up to approximately 59 days after initial study drug dose |
| t1/2 of EE/Levonorgestrel | Terminal phase elimination half-life (t1/2) of EE/Levonorgestrel | Up to approximately 59 days after initial study drug dose |
| AUCt of Venetoclax | Area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt) of Venetoclax | Up to approximately 59 days after initial study drug dose |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duplicate_Henry Ford Health System /ID# 209090 | Completed | Detroit | Michigan | 48202 | United States | |
Not provided
| Label | URL |
|---|---|
| Related info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ethinyl estradiol/levonorgestrel | Drug | tablet; oral |
|
|
| AUCt of EE/Levonorgestrel |
Area under the plasma concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt) of EE/Levonorgestrel |
| Up to approximately 59 days after initial study drug dose |
| AUCinf of EE/Levonorgestrel | AUC from time 0 extrapolated to infinite time (AUCinf) of EE/Levonorgestrel. | Up to approximately 59 days after initial study drug dose |
| Dartmouth-Hitchcock Medical Center /ID# 169097 |
| Completed |
| Lebanon |
| New Hampshire |
| 03756 |
| United States |
| Gabrail Cancer Center Research /ID# 207039 | Completed | Canton | Ohio | 44718 | United States |
| Peter MacCallum Cancer Centre-East Melbourne /ID# 225247 | Recruiting | East Melbourne | Victoria | 3002 | Australia |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D009369 | Neoplasms |
| D012008 | Recurrence |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C579720 | venetoclax |
| D019304 | Ethinyl Estradiol-Norgestrel Combination |
| ID | Term |
|---|---|
| D004997 | Ethinyl Estradiol |
| D009651 | Norpregnatrienes |
| D009650 | Norpregnanes |
| D009654 | Norsteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009644 | Norgestrel |
| D009652 | Norpregnenes |
| D042782 | Estrogenic Steroids, Alkylated |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided