Phase 1b Acute Myelogenous Leukemia (AML) Study With ABT-199 + Decitabine or Azacitidine (Chemo Combo)
Conditions
Acute Myelogenous Leukemia - Myelogenous Leukemia - Treatment Naive AML
Conditions: official terms
Leukemia - Leukemia, Myeloid - Leukemia, Myeloid, Acute
Conditions: Keywords
GDC-0199, Myelogenous Leukemia, Untreated AML, ABT-199, Treatment Naive AML, AML, Acute Myelogenous Leukemia
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: ABT-199 Type: Drug
Name: Decitabine Type: Drug
Name: Azacitidine Type: Drug
Name: Posaconazole Type: Drug
Overall Status
Recruiting
Summary
This is a Phase 1b, open-label, non-randomized, multicenter study to evaluate the safety of orally administered ABT-199 combined with decitabine or azacitidine and the preliminary efficacy of one of these combinations. In addition, there is a DDI sub-study only at a single site, to assess the pharmacokinetics and safety of ABT-199 in combination with posaconazole.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 65 Years
Gender: Both
Criteria: Inclusion Criteria:

1. Subjects must have histological confirmation of AML by WHO criteria and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to co-morbidity or other factors.

2. Subjects must have received no prior treatment for AML with the exception of hydroxyurea, allowed through the first cycle of study treatment. NOTE: Subject may have been treated for prior Myelodysplastic Syndrome (excluding hypomethylating agents).

3. Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2.

4. 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.

5. Subject must have adequate liver function.

Exclusion Criteria:

1. Subject has received treatment with a hypomethylating agent and/or cytarabine for a pre-existing myeloid disorder.

2. Subject must not have favorable risk cytogenetics as categorized by the NCCN Guidelines Version 2, 2014 for Acute Myeloid Leukemia.

3. Subject has t(8;21), inv(16) or t(15;17) karyotype abnormalities.

4. Subject has acute promyelocytic leukemia (French-American-British Class M3 AML).

5. Subject has known active CNS involvement with AML.

6. Subject has received the following within 7 days prior to the initiation of study treatment:

- Potent CYP3A inducers such as rifampin, carbamazepine, phenytoin, and St. John's wort;

- Warfarin or requires the use of warfarin and its equivalent drugs, such as phenprocoumon; (due to potential drug-drug interactions that may potentially increase the exposure of warfarin and complications of anticoagulant effect).

- CYP3A inhibitors such as fluconazole, ketoconazole, and clarithromycin.

7. 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.

8. Subject has a white blood cell count > 25 × 10^9/L. Note: Hydroxyurea is permitted to meet this criterion.

9. Subject is a candidate for a bone marrow or stem cell transplant within 12 weeks after study enrollment.
Locations
Site Reference ID/Investigator# 129718
Duarte, California, United States
Status: Recruiting
Site Reference ID/Investigator# 129719
Sacramento, California, United States
Status: Recruiting
Site Reference ID/Investigator# 127859
Aurora, Colorado, United States
Status: Recruiting
Site Reference ID/Investigator# 129715
Atlanta, Georgia, United States
Status: Recruiting
Site Reference ID/Investigator# 128741
Chicago, Illinois, United States
Status: Not yet recruiting
Site Reference ID/Investigator# 128742
Chicago, Illinois, United States
Status: Recruiting
Site Reference ID/Investigator# 129699
Baltimore, Maryland, United States
Status: Recruiting
Site Reference ID/Investigator# 127857
Boston, Massachusetts, United States
Status: Recruiting
Site Reference ID/Investigator# 130289
New York, New York, United States
Status: Recruiting
Site Reference ID/Investigator# 129720
Durham, North Carolina, United States
Status: Recruiting
Site Reference ID/Investigator# 127860
Houston, Texas, United States
Status: Recruiting
Site Reference ID/Investigator# 129717
Seattle, Washington, United States
Status: Recruiting
Site Reference ID/Investigator# 130352
East Melbourne, Australia
Status: Not yet recruiting
Site Reference ID/Investigator# 130356
Kogarah, Australia
Status: Not yet recruiting
Site Reference ID/Investigator# 130353
Melbourne, Australia
Status: Recruiting
Site Reference ID/Investigator# 130342
Dresden, Germany
Status: Not yet recruiting
Start Date
November 2014
Completion Date
May 2017
Sponsors
AbbVie
Source
AbbVie
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page