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

NCT03557619 | Recruiting Phase 1 FDA Drug

• 1 other identifier: M16-185
• Study Type: interventional
• Target: 12
• Locations: 2 countries
• Sites: 4

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. 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.

Conditions

Hematologic Malignancies

Keywords

Cancer; Hematologic Malignancies, venetoclax; ethinyl estradiol; relapsed or refractory non-Hodgkin's lymphoma; non-Hodgkin's lymphoma

Outcome Measures

Primary Outcomes (9)

• 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

• 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

Study Arms (1)

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.

Drug: Venetoclax; Drug: ethinyl estradiol/levonorgestrel

Interventions

Venetoclax DRUG

tablet; oral

Also known as: ABT-199, GDC-0199, Venclexta

Ethinyl estradiol/Levonorgestrel and Venetoclax

ethinyl estradiol/levonorgestrel DRUG

tablet; oral

Also known as: Levora

Ethinyl estradiol/Levonorgestrel and Venetoclax

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (4)

Duplicate_Henry Ford Health System /ID# 209090

Detroit, Michigan, 48202, United States

COMPLETED

Dartmouth-Hitchcock Medical Center /ID# 169097

Lebanon, New Hampshire, 03756, United States

COMPLETED

Gabrail Cancer Center Research /ID# 207039

Canton, Ohio, 44718, United States

COMPLETED

Peter MacCallum Cancer Centre-East Melbourne /ID# 225247

East Melbourne, Victoria, 3002, Australia

RECRUITING

Related Links

• Related info

MeSH Terms

Conditions

Hematologic Neoplasms; Neoplasms; Recurrence; Lymphoma, Non-Hodgkin

Interventions

venetoclax; Ethinyl Estradiol-Norgestrel Combination

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethinyl Estradiol; Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Norgestrel; Norpregnenes; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 15, 2018
• Study Start: July 30, 2019
• Primary Completion: March 21, 2026
• Study Completion: March 21, 2026
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); AU (1)