Status:
TERMINATED
Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine (Chemo Combo) in Subjects With Acute Myelogenous Leukemia (AML)
Lead Sponsor:
AbbVie
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Acute Myelogenous Leukemia
Myelogenous Leukemia
Eligibility:
All Genders
60+ years
Phase:
PHASE1
Brief Summary
This is a Phase 1b, open-label, non-randomized, multicenter study to evaluate the safety and pharmacokinetics of orally administered venetoclax (ABT-199) combined with decitabine or azacitidine and th...
Eligibility Criteria
Inclusion
- Subjects must have confirmation of Acute Myeloid Leukemia (AML) by WHO criteria and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to co-morbidity or other factors.
- Subject must have received no prior treatment for AML with the exception of hydroxyurea
- Subjects must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 for subjects greater than or equal to 75 years of age, or 0 to 3 for subjects greater than or equal to 60 to 74 years of age
- Subject must have adequate kidney and liver function as described in the protocol
Exclusion
- Subject has received treatment with the following hypomethylating agent and/or chemo therapeutic agent for for an antecedent hematologic disorder (AHD) (Subjects may have been treated with other agents for AHD i.e., Myelodysplastic syndrome \[MDS\])
- Subject has history of Myeloproliferative Neoplasm (MPN).
- Subject has favorable risk cytogenetics as categorized by the National Comprehensive Cancer Network Guidelines Version 2, 2014 for AML.
- Subject has t(8;21), inv(16), t(16;16) or t(15;17) karyotype abnormalities.
- Subject has acute promyelocytic leukemia.
- Subject has known active central nervous system involvement with AML.
- Subject has received a strong and/or moderate CYP3A inducer within 7 days prior to the initiation of study treatment.
- Subject has a history of other malignancies prior to study entry, with the exception of:
- Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast;
- Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
- Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
- Subject has a white blood cell count \> 25 × 10\^9/L. Note: Hydroxyurea is permitted to meet this criterion.
Key Trial Info
Start Date :
October 6 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2022
Estimated Enrollment :
212 Patients enrolled
Trial Details
Trial ID
NCT02203773
Start Date
October 6 2014
End Date
June 16 2022
Last Update
May 16 2023
Active Locations (23)
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1
City of Hope /ID# 129718
Duarte, California, United States, 91010
2
University of California, Davis Comprehensive Cancer Center /ID# 129719
Sacramento, California, United States, 95817
3
Univ of Colorado Cancer Center /ID# 127859
Aurora, Colorado, United States, 80045
4
Emory Midtown Infectious Disease Clinic /ID# 129715
Atlanta, Georgia, United States, 30322