Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine (Chemo Combo) in Subjects With Acute Myelogenous Leukemia (AML)

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.