deltatrials
Terminated PHASE2 INTERVENTIONAL 1-arm NCT00644878

Study of Molecular Response in Adult Patients on Nilotinib With Philadelphia Chromosome Positive Chronic Myelogenous Leukemia (Ph+ CML) in Chronic Phase and a Suboptimal Molecular Response to Imatinib (MACS0254)

A Multi-center, Open-label, Exploratory Study of Bcr-Abl Kinetics in Adult Patients on Nilotinib With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) and a Suboptimal Molecular Response to Imatinib

Sponsor: Novartis Pharmaceuticals

Interventions Nilotinib
Updated 8 times since 2017 Last updated: Jul 26, 2021 Started: Oct 31, 2008 Primary completion: Mar 31, 2012 Completion: Mar 31, 2012
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Slower than expected enrollment

A PHASE2 clinical study on Chronic Myelogenous Leukemia - Chronic Phase, this trial is terminated or withdrawn. The trial is conducted by Novartis Pharmaceuticals and has accumulated 8 data snapshots since 2008. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshotCompleted~Sep 2021 – ~Dec 2021 · 3 months · monthly snapshotTerminated~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 23 months · monthly snapshotTerminated

Change History

8 versions recorded
  1. Sep 2024 — Present [monthly]

    Terminated PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2

  3. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE2

  4. Sep 2021 — Dec 2021 [monthly]

    Terminated PHASE2

    Status: CompletedTerminated · Phase: PHASE4PHASE2

  5. Jan 2021 — Sep 2021 [monthly]

    Completed PHASE4

Show 3 earlier versions
  1. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE4

  2. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE4

  3. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE4

    First recorded

Oct 2008

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Novartis Pharmaceuticals
Data source: Novartis

For direct contact, visit the study record on ClinicalTrials.gov .