Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine (Chemo Combo) in Subjects With Acute Myelogenous Leukemia (AML)
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ClinicalTrials.gov Identifier: NCT02203773 |
Recruitment Status :
Active, not recruiting
First Posted : July 30, 2014
Last Update Posted : December 22, 2020
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Condition or disease | Intervention/treatment | Phase |
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Acute Myelogenous Leukemia Myelogenous Leukemia Treatment Naive AML | Drug: Posaconazole Drug: ABT-199 Drug: Decitabine Drug: Azacitidine | Phase 1 Phase 2 |
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 260 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | October 6, 2014 |
Estimated Primary Completion Date : | September 27, 2021 |
Estimated Study Completion Date : | September 27, 2021 |

Arm | Intervention/treatment |
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Experimental: ABT-199 + Azacitidine
Treatment Naive Acute Myelogenous Leukemia
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Drug: ABT-199
ABT-199 is taken orally once daily starting on Day 2 of cycle 1 and begin on day 1 of every other cycle thereafter. This is a dose escalation study, therefore the dose of ABT-199 will change. Drug: Azacitidine Azacitidine will be administered by IV infusion over 10 to 40 minutes or subcutaneously based on the institutional guidelines, beginning on Day 1 through Day 7 of each Cycle, for a minimum of 4 Cycles. |
Experimental: ABT-199 + Decitabine
Treatment Naive Acute Myelogenous Leukemia
|
Drug: ABT-199
ABT-199 is taken orally once daily starting on Day 2 of cycle 1 and begin on day 1 of every other cycle thereafter. This is a dose escalation study, therefore the dose of ABT-199 will change. Drug: Decitabine Decitabine will be administered by IV infusion over 1 hour beginning on Day 1 thru Day 5 of each Cycle for a minimum of 4 Cycles |
Experimental: ABT-199+Decitabine+Posaconazole
Treatment Naive Acute Myelogenous Leukemia
|
Drug: Posaconazole
Posaconazole will be administered orally twice a day on Cycle 1 Day 21 and once daily from Cycle 1 Day 22 to Cycle 1 Day 28. Drug: ABT-199 ABT-199 is taken orally once daily starting on Day 2 of cycle 1 and begin on day 1 of every other cycle thereafter. This is a dose escalation study, therefore the dose of ABT-199 will change. Drug: Decitabine Decitabine will be administered by IV infusion over 1 hour beginning on Day 1 thru Day 5 of each Cycle for a minimum of 4 Cycles |
- Complete Remission Rate [ Time Frame: Measured up to 1 year after the last subject last dose ]Complete Remission Rate will be determined by the number of subjects who achieve a Complete Remission.
- The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration (AUCt) [ Time Frame: For approximately 5 days following a single dose of ABT-199. ]The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration.
- Complete Remission with incomplete blood count recovery rate [ Time Frame: Measured up to 1 year after the last subject last dose ]Complete Remission with incomplete blood count recovery Rate will be determined by the number of subjects who achieve a Complete Remission with incomplete blood count recovery.
- half-life (t1/2) [ Time Frame: For approximately 5 days following a single dose of ABT-199. ]The time required for the concentration of the drug to reach half of its original value.
- Maximum observed plasma concentration (Cmax) [ Time Frame: For approximately 5 days following a single dose of ABT-199. ]Maximum observed concentration, occurring at Tmax.
- Overall Response Rate [ Time Frame: Measured up to 1 year after the last subject last dose ]Overall response rate will be defined as the proportion of subjects who achieve a complete remission (CR), complete remission incomplete (CRi), or partial remission(PR) per the International Working Group criteria for AML.
- Clearance (CL) [ Time Frame: For approximately 5 days following a single dose of ABT-199. ]Clearance is defined as the rate at which drug is cleared from the blood.
- AUC from 0-24 (AUC0-24) [ Time Frame: For approximately 5 days following a single dose of ABT-199. ]The area under the plasma concentration-time curve (AUC) over a 24-hour dose interval.
- Time to Cmax (peak time, Tmax), [ Time Frame: For approximately 5 days following a single dose of ABT-199. ]The time at which maximum plasma concentration (Cmax) is observed.
- AUC from 0 to infinity (AUC∞) [ Time Frame: For approximately 5 days following a single dose of ABT-199. ]Area under the plasma concentration-versus-time curve from time zero to infinity.
- Overall Survival [ Time Frame: Measured up to 1 year after the last subject last dose ]Overall survival will be defined as the number of days from the date of enrollment to the date of death.
- Percent of subjects who move on to stem cell transplant [ Time Frame: Measured up to 1 year after the last subject last dose ]The percent of subjects who move on to stem cell transplant will be summarized.
- Duration of Response [ Time Frame: Measured up to 1 year after the last subject last dose ]Duration of response will be defined as the number of days from the date of first response per the IWG criteria for AML to the earliest recurrence or progressive disease (PD).
- Event Free Survival [ Time Frame: Measured up to 1 year after the last subject last dose ]Event-free survival (EFS) will be defined as the number of days from the date of first dose to the date of earliest evidence of relapse, subsequent treatment other than stem cell transplant while in composite complete response (CR + CRi), or death.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203773

Study Director: | AbbVie Inc. | AbbVie |
Responsible Party: | AbbVie |
ClinicalTrials.gov Identifier: | NCT02203773 |
Other Study ID Numbers: |
M14-358 2014-000687-18 ( EudraCT Number ) |
First Posted: | July 30, 2014 Key Record Dates |
Last Update Posted: | December 22, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
Time Frame: | Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. |
Access Criteria: | Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. |
URL: | https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Acute Myelogenous Leukemia AML Myelogenous Leukemia ABT-199 |
GDC-0199 Treatment Naive AML Untreated AML |
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type Neoplasms Posaconazole Azacitidine Decitabine Venetoclax Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Enzyme Inhibitors Antifungal Agents Anti-Infective Agents Trypanocidal Agents Antiprotozoal Agents Antiparasitic Agents 14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |