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NCT02081378

A Phase I Study of Oral Asciminib (ABL001) in Patients With CML or Ph+ ALL

Completed Phase 1 Last updated 18 March 2024
What this trial tests

Phase 1 trial testing Asciminib (ABL001) in Chronic Myelogenous Leukemia in 326 participants. Completed in 14 March 2023.

Timeline
24 April 2014
Primary endpoint
3 June 2021
14 March 2023

Quick facts

Lead sponsorNovartis Pharmaceuticals
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment326
Start date24 April 2014
Primary completion3 June 2021
Estimated completion14 March 2023
Sites18 locations across France, Italy, Japan, Netherlands, Germany, South Korea, Australia, Singapore

Drugs / interventions tested

Conditions studied

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Chronic Myelogenous Leukemia or Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The design of a phase I, open label, dose finding study was chosen in order to establish a safe and tolerated dose of single agent ABL001 in Chronic myeloid leukemia (CML) and Philadelphia chromosome positive Acute lymphoblastic leukemia (Ph+ ALL) patients who are relapsed or refractory to or are intolerant of Tyrosine kinase inhibitors (TKIs), and of ABL001+Nilotinib, ABL001+Imatinib and ABL001+Dasatinib in Ph positive CML patients who are relapsed or refractory to TKIs.

Publications & conference data

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

  1. Small molecules in targeted cancer therapy: advances, challenges, and future perspectives.
    Zhong L, Li Y, Xiong L, Wang W, et al · · 2021 · cited 1003× · PMID 34054126 · DOI 10.1038/s41392-021-00572-w
  2. Asciminib in Chronic Myeloid Leukemia after ABL Kinase Inhibitor Failure.
    Hughes TP, Mauro MJ, Cortes JE, Minami H, et al · · 2019 · cited 338× · PMID 31826340 · DOI 10.1056/nejmoa1902328
  3. Combining the Allosteric Inhibitor Asciminib with Ponatinib Suppresses Emergence of and Restores Efficacy against Highly Resistant BCR-ABL1 Mutants.
    Eide CA, Zabriskie MS, Savage Stevens SL, Antelope O, et al · · 2019 · cited 182× · PMID 31543464 · DOI 10.1016/j.ccell.2019.08.004
  4. Insights into the post-translational modification and its emerging role in shaping the tumor microenvironment.
    Li W, Li F, Zhang X, Lin HK, et al · · 2021 · cited 147× · PMID 34924561 · DOI 10.1038/s41392-021-00825-8
  5. Resistance to Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia-From Molecular Mechanisms to Clinical Relevance.
    Alves R, Gonçalves AC, Rutella S, Almeida AM, et al · · 2021 · cited 112× · PMID 34638304 · DOI 10.3390/cancers13194820
  6. Asciminib vs bosutinib in chronic-phase chronic myeloid leukemia previously treated with at least two tyrosine kinase inhibitors: longer-term follow-up of ASCEMBL.
    Hochhaus A, Réa D, Boquimpani C, Minami Y, et al · · 2023 · cited 104× · PMID 36717654 · DOI 10.1038/s41375-023-01829-9
  7. Third-line therapy for chronic myeloid leukemia: current status and future directions.
    Cortes J, Lang F. · · 2021 · cited 83× · PMID 33736651 · DOI 10.1186/s13045-021-01055-9
  8. The Emerging Role of ABL Kinases in Solid Tumors.
    Wang J, Pendergast AM. · · 2015 · cited 75× · PMID 26645050 · DOI 10.1016/j.trecan.2015.07.004

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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/NCT02081378.

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