NCT02203773 is a Phase 1 clinical trial of Posaconazole in Acute Myelogenous Leukemia, sponsored by AbbVie.

Who is sponsoring NCT02203773?

NCT02203773 is sponsored by AbbVie.

What drugs are being tested in NCT02203773?

Interventions in NCT02203773: Posaconazole, ABT-199, Decitabine, Azacitidine.

What condition does NCT02203773 study?

NCT02203773 studies Acute Myelogenous Leukemia, Myelogenous Leukemia, Treatment Naive AML.

Is NCT02203773 still recruiting?

NCT02203773 is currently terminated. Last updated 16 May 2023.

Last reviewed 2023-05-16 · How we verify

NCT02203773

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 1 Last updated 16 May 2023

What this trial tests

Phase 1 trial testing Posaconazole in Acute Myelogenous Leukemia in 212 participants. Terminated before completion.

Timeline

6 October 2014

Primary endpoint
16 June 2022

16 June 2022

Quick facts

Lead sponsor	AbbVie
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	212
Start date	6 October 2014
Primary completion	16 June 2022
Estimated completion	16 June 2022
Sites	23 locations across France, Germany, United States, Australia

Drugs / interventions tested

Posaconazole — full drug profile →
ABT-199 — full drug profile →
Decitabine (decitabine) — full drug profile →
Azacitidine (azacitidine) — full drug profile →

Conditions studied

Acute Myelogenous Leukemia — all drugs for Acute Myelogenous Leukemia →
Myelogenous Leukemia — all drugs for Myelogenous Leukemia →
Treatment Naive AML — all drugs for Treatment Naive AML →

Sponsor

AbbVie — full company profile →

Who can join

60 and older, any sex, with Acute Myelogenous Leukemia or Myelogenous Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Venetoclax combined with decitabine or azacitidine in treatment-naive, elderly patients with acute myeloid leukemia.
DiNardo CD, Pratz K, Pullarkat V, Jonas BA, et al · · 2019 · cited 1364× · PMID 30361262 · DOI 10.1182/blood-2018-08-868752
Efficacy and Biological Correlates of Response in a Phase II Study of Venetoclax Monotherapy in Patients with Acute Myelogenous Leukemia.
Konopleva M, Pollyea DA, Potluri J, Chyla B, et al · · 2016 · cited 878× · PMID 27520294 · DOI 10.1158/2159-8290.cd-16-0313
Molecular patterns of response and treatment failure after frontline venetoclax combinations in older patients with AML.
DiNardo CD, Tiong IS, Quaglieri A, MacRaild S, et al · · 2020 · cited 568× · PMID 31932844 · DOI 10.1182/blood.2019003988
Safety and preliminary efficacy of venetoclax with decitabine or azacitidine in elderly patients with previously untreated acute myeloid leukaemia: a non-randomised, open-label, phase 1b study.
DiNardo CD, Pratz KW, Letai A, Jonas BA, et al · · 2018 · cited 550× · PMID 29339097 · DOI 10.1016/s1470-2045(18)30010-x
Isocitrate dehydrogenase mutations in myeloid malignancies.
Medeiros BC, Fathi AT, DiNardo CD, Pollyea DA, et al · · 2017 · cited 257× · PMID 27721426 · DOI 10.1038/leu.2016.275
Fatty acid metabolism underlies venetoclax resistance in acute myeloid leukemia stem cells.
Stevens BM, Jones CL, Pollyea DA, Culp-Hill R, et al · · 2020 · cited 237× · PMID 33884374 · DOI 10.1038/s43018-020-00126-z
Pathways and mechanisms of venetoclax resistance.
Bose P, Gandhi V, Konopleva M. · · 2017 · cited 223× · PMID 28140720 · DOI 10.1080/10428194.2017.1283032
Management of Venetoclax-Posaconazole Interaction in Acute Myeloid Leukemia Patients: Evaluation of Dose Adjustments.
Agarwal SK, DiNardo CD, Potluri J, Dunbar M, et al · · 2017 · cited 195× · PMID 28161120 · DOI 10.1016/j.clinthera.2017.01.003

Verify or expand the search:

Other trials of Posaconazole

Trials testing the same drug.

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NCT04771130 — A Study of BGB-11417 in Participants With Myeloid Malignancies · Phase 1, PHASE2 · recruiting

Other recruiting trials for Acute Myelogenous Leukemia

Currently open trials in the same condition.

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NCT06131801 — Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution · recruiting
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Other AbbVie trials

Trials by the same sponsor.

NCT07219017 — A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants · Phase 1 · completed
NCT05316220 — A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years W · Phase 3 · withdrawn
NCT07024797 — Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult · Phase 1 · completed
NCT07058051 — Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China · completed
NCT07007091 — A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02203773 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 16 May 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02203773.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing