A Phase 2 Study of ABT-199 in Subjects With Acute Myelogenous Leukemia (AML)



Status:Completed
Conditions:Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - 99
Updated:4/21/2016
Start Date:November 2013
End Date:December 2014

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A Phase 2, Open-Label, Multicenter study evaluating the preliminary efficacy and safety of
ABT-199 administered orally in patients with AML.


Inclusion Criteria: 1. Histological or cytological confirmation of relapsed or refractory
AML (by World Health Organization (WHO) classification) or untreated AML in patients who
are unfit for intensive therapy.

2. Subject has an Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.

3. Subject must have adequate renal function as demonstrated by a calculated creatinine
clearance ≥ 50 mL/min; determined via urine collection for 24-hour creatinine clearance or
by the Cockcroft Gault formula using ideal body mass (IBM) instead of mass.

4. Subject must have adequate liver function. Exclusion Criteria: 1. Subject has received
acute anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal or
any investigational therapy within 14 days or 5 half-lives (whichever is shorter) prior to
first dose of ABT-199.

2. Subject has received a monoclonal antibody for anti-neoplastic intent within 8 weeks
prior to the first dose of study drug.

3. Subject has received Potent CYP3A inducers (such as rifampin, carbamazepine, phenytoin
and St. John's wort and Warfarin or requires the use of warfarin (due to potential
drug-drug interactions that may potentially increase the exposure of warfarin and
complications of this effect) within 7 days prior to the first dose of study drug.

4. Subject has received CYP3A inhibitors (such as fluconazole, ketoconazole, and
clarithromycin) within 5 days prior to the first dose of study drug.

5. Subject has a white blood cell count > 25 x 10^9/L. 6. Subject has acute promyelocytic
leukemia (French-American-British Class M3 AML).

7. Subjects with known active CNS disease.
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