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NCT02292550

Study of Safety and Efficacy of LEE011 and Ceritinib in Patients With ALK-positive Non-small Cell Lung Cancer.

Completed Phase 1 Last updated 17 December 2020
What this trial tests

Phase 1 trial testing Ribociclib in Non-small Cell Lung Cancer in 27 participants. Completed in 26 September 2018.

Timeline
14 May 2015
Primary endpoint
26 September 2018
26 September 2018

Quick facts

Lead sponsorNovartis Pharmaceuticals
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment27
Start date14 May 2015
Primary completion26 September 2018
Estimated completion26 September 2018
Sites8 locations across France, Italy, Taiwan, South Korea, United States, Spain

Drugs / interventions tested

Conditions studied

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This was a Phase Ib/II study of the ALK inhibitor ceritinib in combination with the CDK4/6 inhibitor LEE011 in patients with ALK-positive non-small cell lung cancer. The purpose of the study was to determine the MTD/RP2D of the LEE011 and ceritinib combination and evaluate whether the combination was safe and had beneficial effects in ALK-positive advanced non-small cell lung cancer patients. This trial did not progress to Phase II. Trial population terminated before reaching Phase II

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. Cyclin D1, cancer progression, and opportunities in cancer treatment.
    Qie S, Diehl JA. · · 2016 · cited 527× · PMID 27695879 · DOI 10.1007/s00109-016-1475-3
  3. Targeting ALK: Precision Medicine Takes on Drug Resistance.
    Lin JJ, Riely GJ, Shaw AT. · · 2017 · cited 411× · PMID 28122866 · DOI 10.1158/2159-8290.cd-16-1123
  4. AXL receptor tyrosine kinase as a promising anti-cancer approach: functions, molecular mechanisms and clinical applications.
    Zhu C, Wei Y, Wei X. · · 2019 · cited 398× · PMID 31684958 · DOI 10.1186/s12943-019-1090-3
  5. CDK4/6 Inhibitors: The Mechanism of Action May Not Be as Simple as Once Thought.
    Klein ME, Kovatcheva M, Davis LE, Tap WD, et al · · 2018 · cited 308× · PMID 29731395 · DOI 10.1016/j.ccell.2018.03.023
  6. Fusions in solid tumours: diagnostic strategies, targeted therapy, and acquired resistance.
    Schram AM, Chang MT, Jonsson P, Drilon A. · · 2017 · cited 270× · PMID 28857077 · DOI 10.1038/nrclinonc.2017.127
  7. The Strange Case of CDK4/6 Inhibitors: Mechanisms, Resistance, and Combination Strategies.
    Knudsen ES, Witkiewicz AK. · · 2017 · cited 218× · PMID 28303264 · DOI 10.1016/j.trecan.2016.11.006
  8. Selective inhibition of CDK4/6: A safe and effective strategy for developing anticancer drugs.
    Yuan K, Wang X, Dong H, Min W, et al · · 2021 · cited 103× · PMID 33532179 · DOI 10.1016/j.apsb.2020.05.001

Verify or expand the search:

Other trials of Ribociclib

Trials testing the same drug.

Other recruiting trials for Non-small Cell Lung Cancer

Currently open trials in the same condition.

Other Novartis Pharmaceuticals trials

Trials by the same sponsor.

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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/NCT02292550.

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