Last reviewed · How we verify

NCT03557970

JNJ-40346527 in Treating Participants With Relapsed or Refractory Acute Myeloid Leukemia

Terminated Phase 2 Results posted Last updated 2 December 2021
What this trial tests

Phase 2 trial testing Edicotinib in Recurrent Acute Myeloid Leukemia in 3 participants. Terminated before completion.

Timeline
5 October 2018
Primary endpoint
28 September 2020
28 September 2020

Quick facts

Lead sponsorOHSU Knight Cancer Institute
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment3
Start date5 October 2018
Primary completion28 September 2020
Estimated completion28 September 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

OHSU Knight Cancer Institute

Who can join

18 and older, any sex, with Recurrent Acute Myeloid Leukemia or Refractory Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence of Treatment-related and Non-treatment Related Adverse Events Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Secondary · Start of study drug until 30 days after the last dose of study drug (while the participant remains on-study), which amounted to an average of 31 days for the 3 enrolled participants

The overall incidence of treatment-related and non-treatment-related toxicity (including serious and non-serious AEs). See the Adverse Event module of the Results section for a tabular summary of each toxicity event and associated system organ class.

Treatment-related AE's (any grade)
GroupValue95% CI
Assay Positive0
Assay Negative0
Non-treatment-related AE's (any grade)
GroupValue95% CI
Assay Positive1
Assay Negative2
Overall Survival Secondary · From study enrollment until end of participant follow-up (i.e., death or last contact), with the protocol specifying that "[p]articipants will be followed … until death"

Defined for all patients of a trial; measured from the date of entry into a study to the date of death from any cause; patients not known to have died at end of study are censored on the date they were last known to be alive. The Kaplan-Meier method will be used to estimate overall survival.

GroupValue95% CI
Assay PositiveNANA – NA
Assay Negative6.6NA – NA

Adverse events — posted to ClinicalTrials.gov

Time frame: Per protocol "from the time subject has started study drug to completion of the study.", with post- drug exposure on-study time periods of 12, 38, and 189 days (mean of 80 days) for the 3 enrolled participants. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Assay Positive
Serious: 1/1 (100%)
Deaths: 0/1
Assay Negative
Serious: 0/2 (0%)
Deaths: 1/2

Serious adverse events (1 terms)

ReactionSystemAssay PositiveAssay Negative
Catheter related infectionInfections and infestations
Other adverse events (9 terms — click to expand)

ReactionSystemAssay PositiveAssay Negative
Abdominal painGastrointestinal disorders
Bone pain (worsening)Musculoskeletal and connective tissue disorders
DiarrheaGastrointestinal disorders
Generalized muscle weaknessMusculoskeletal and connective tissue disorders
HyperkalemiaMetabolism and nutrition disorders
Mucositis oralGastrointestinal disorders
NauseaGastrointestinal disorders
Pain in extremityGeneral disorders
Thromboembolic eventVascular disorders

Most-reported serious reactions: Catheter related infection.

Data from ClinicalTrials.gov NCT03557970 adverse events section.

Sponsor's own description

This phase II trial studies how well edicotinib (JNJ-40346527) works in treating participants with acute myeloid leukemia that has come back or does not respond to treatment. JNJ-40346527 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Publications & conference data

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

  1. Tumor-associated macrophages: potential therapeutic strategies and future prospects in cancer.
    Li C, Xu X, Wei S, Jiang P, et al · · 2021 · cited 259× · PMID 33504575 · DOI 10.1136/jitc-2020-001341
  2. An expanded universe of cancer targets.
    Hahn WC, Bader JS, Braun TP, Califano A, et al · · 2021 · cited 160× · PMID 33667368 · DOI 10.1016/j.cell.2021.02.020
  3. Small molecule inhibitors targeting the cancers.
    Liu GH, Chen T, Zhang X, Ma XL, et al · · 2022 · cited 127× · PMID 36254250 · DOI 10.1002/mco2.181
  4. Harnessing the tumor microenvironment: targeted cancer therapies through modulation of epithelial-mesenchymal transition.
    Glaviano A, Lau HS, Carter LM, Lee EHC, et al · · 2025 · cited 90× · PMID 39806516 · DOI 10.1186/s13045-024-01634-6
  5. Research trends in pharmacological modulation of tumor-associated macrophages.
    Wang N, Wang S, Wang X, Zheng Y, et al · · 2021 · cited 88× · PMID 33463063 · DOI 10.1002/ctm2.288
  6. Targeting of TAMs: can we be more clever than cancer cells?
    Kzhyshkowska J, Shen J, Larionova I. · · 2024 · cited 79× · PMID 39516356 · DOI 10.1038/s41423-024-01232-z
  7. Targeting Tumor Associated Macrophages to Overcome Conventional Treatment Resistance in Glioblastoma.
    Grégoire H, Roncali L, Rousseau A, Chérel M, et al · · 2020 · cited 61× · PMID 32322199 · DOI 10.3389/fphar.2020.00368
  8. Understanding the Differentiation, Expansion, Recruitment and Suppressive Activities of Myeloid-Derived Suppressor Cells in Cancers.
    Lim HX, Kim TS, Poh CL. · · 2020 · cited 60× · PMID 32443699 · DOI 10.3390/ijms21103599

Verify or expand the search:

Other recruiting trials for Recurrent Acute Myeloid Leukemia

Currently open trials in the same condition.

Other OHSU Knight Cancer Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT03557970.

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