Summary

Eligibility
for people ages 60 years and up (full criteria)
Location
at UC Davis
Dates
study started
estimated completion

Description

Summary

This is a Phase 1b, open-label, non-randomized, multicenter study to evaluate the safety and pharmacokinetics of orally administered ABT-199 combined with decitabine or azacitidine and the preliminary efficacy of these combinations. In addition, there is a drug-drug interaction (DDI) sub-study only at a single site, to assess the pharmacokinetics and safety of ABT-199 in combination with posaconazole.

Official Title

A Phase 1b Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine in Treatment-Naive Subjects With Acute Myelogenous Leukemia Who Are Greater Than or Equal to 60 Years of Age and Who Are Not Eligible for Standard Induction Therapy

Keywords

Acute Myelogenous Leukemia Myelogenous Leukemia Treatment Naive AML AML ABT-199 GDC-0199 Untreated AML Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Posaconazole Azacitidine Decitabine Venetoclax ABT-199 + Azacitidine ABT-199 + Decitabine ABT-199+Decitabine+Posaconazole

Eligibility

You can join if…

Open to people ages 60 years and up

  • 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 ) 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

You CAN'T join if...

  • 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 × 109/L. Note: Hydroxyurea is permitted to meet this criterion.

Locations

  • UC Davis Comprehensive Cancer Center - Main /ID# 129719
    Sacramento California 95817 United States
  • City of Hope /ID# 129718
    Duarte California 91010 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT02203773
Phase
Phase 1/2
Study Type
Interventional
Last Updated