Acute Myelogenous Leukemia Clinical Trial
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
Verified date | May 2023 |
Source | AbbVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a Phase 1b, open-label, non-randomized, multicenter study to evaluate the safety and pharmacokinetics of orally administered venetoclax (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 venetoclax (ABT-199) in combination with posaconazole.
Status | Terminated |
Enrollment | 212 |
Est. completion date | June 16, 2022 |
Est. primary completion date | June 16, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | 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 0 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. |
Country | Name | City | State |
---|---|---|---|
Australia | St George Hospital /ID# 130356 | Kogarah | New South Wales |
Australia | Alfred Health /ID# 130353 | Melbourne | Victoria |
Australia | Peter MacCallum Cancer Ctr /ID# 130352 | Melbourne | Victoria |
France | AP-HP - Hopital Saint-Louis /ID# 130349 | Paris | |
France | Hopital Haut-Lévêque /ID# 134388 | Pessac CEDEX | Gironde |
France | Duplicate_Hopital Universitaire Purpan /ID# 134389 | Toulouse | Haute-Garonne |
Germany | Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 130342 | Dresden | |
Germany | Universitaetsklinikum Leipzig /ID# 130346 | Leipzig | Sachsen |
Germany | Duplicate_Klinikum Rechts der Isar /ID# 130347 | Munich | |
Germany | Universitaetsklinikum Ulm /ID# 130341 | Ulm | Baden-Wuerttemberg |
United States | Emory Midtown Infectious Disease Clinic /ID# 129715 | Atlanta | Georgia |
United States | Univ of Colorado Cancer Center /ID# 127859 | Aurora | Colorado |
United States | Johns Hopkins University /ID# 129699 | Baltimore | Maryland |
United States | Dana-Farber Cancer Institute /ID# 127857 | Boston | Massachusetts |
United States | Northwestern University Feinberg School of Medicine /ID# 128741 | Chicago | Illinois |
United States | The University of Chicago Medical Center /ID# 128742 | Chicago | Illinois |
United States | City of Hope /ID# 129718 | Duarte | California |
United States | Duke Cancer Center /ID# 129720 | Durham | North Carolina |
United States | University of Texas MD Anderson Cancer Center /ID# 127860 | Houston | Texas |
United States | University of Texas MD Anderson Cancer Center /ID# 141581 | Houston | Texas |
United States | Columbia University Medical Center /ID# 130289 | New York | New York |
United States | University of California, Davis Comprehensive Cancer Center /ID# 129719 | Sacramento | California |
United States | University of Washington /ID# 129717 | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
AbbVie | Genentech, Inc. |
United States, Australia, France, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants Experiencing Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. | Measured up to 1 year after the last subject last dose | |
Primary | Maximum observed plasma concentration (Cmax) | Maximum observed concentration, occurring at Tmax. | For approximately 5 days following a single dose of ABT-199. | |
Primary | Time to Cmax (peak time, Tmax), | The time at which maximum plasma concentration (Cmax) is observed. | For approximately 5 days following a single dose of ABT-199. | |
Primary | The area under the plasma concentration-time curve (AUC) from 0 to 24 hours (AUC0-24) | The area under the plasma concentration-time curve (AUC) over a 24-hour dose interval. | For approximately 5 days following a single dose of ABT-199. | |
Primary | Half-Life (t1/2) | The time required for the concentration of the drug to reach half of its original value. | For approximately 5 days following a single dose of ABT-199. | |
Primary | Clearance (CL) | Clearance is defined as the rate at which drug is cleared from the blood. | For approximately 5 days following a single dose of ABT-199. | |
Primary | Complete Remission Rate | Complete Remission Rate will be determined by the number of subjects who achieve a Complete Remission. | Measured up to 1 year after the last subject last dose | |
Primary | Complete Remission with incomplete blood count recovery rate | 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. | Measured up to 1 year after the last subject last dose | |
Primary | Overall Response Rate | 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. | Measured up to 1 year after the last subject last dose | |
Primary | Overall Survival | Overall survival will be defined as the number of days from the date of first dose to the date of death. | Measured up to 1 year after the last subject last dose | |
Secondary | Event Free Survival | 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. | Measured up to 1 year after the last subject last dose | |
Secondary | Duration of Response | 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). | Measured up to 1 year after the last subject last dose |
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