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NCT02321501

Ceritinib and Everolimus in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIB-IV Non-small Cell Lung Cancer

StatusActive, Not Recruiting
PhasePhase 1
Primary completion (estimated)
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Record History

All 27 versions: 17 with changes below, 10 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 62 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Study description revised
  2. Primary and study completion dates: Dec 31, 2024 to Dec 31, 2026v24
  3. Study Identification, Study Status, Conditionsv23
  4. Primary and study completion dates: Jun 30, 2023 to Dec 31, 2024v19
  5. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 66 to confirmed 37
    • Site details revised
    v17
Show 11 earlier versionsHide 11 earlier versions
  1. Secondary endpoints: details revised at 1 of 3 entries
    • Study description revised
    v15
  2. Eligibility criteria shortened, about 15 wordsv14 Show 11 more changesShow less
    • Primary endpoint revised
    • Primary completion date: Jun 2023 to Jun 30, 2023
    • Study completion date: Jun 2024 to Jun 30, 2023
    • Start date: Jun 2016 to Jun 22, 2016
    • Interventions: Ceritinib (LDK378) (Drug), Ceritinib (LDK378) 750 mg (Drug), Everolimus (Drug) to Ceritinib (Drug), Everolimus (Drug), Laboratory Biomarker Analysis (Other), Pharmacological Study (Other)
    • Secondary endpoints: 1 to 3
    • Study description shortened, about 708 words
    • Study site revised
    • Collaborator revised
    • Study title shortened, about 17 words
    • Study arms: 4 to 1
  3. Study description shortened, about 112 wordsv12
  4. Eligibility criteria revisedv11
  5. Study completion date: Jun 2023 to Jun 2024v10
  6. Eligibility criteria revisedv9
  7. Eligibility criteria expanded, about 12 words
    • Study completion date: Jun 2023
    • Study description expanded, about 14 words
    v8
  8. Study description expanded, about 25 wordsv7
  9. Trial status: Not Yet Recruiting to Recruitingv6 Show 5 more changesShow less
    • Start date: Apr 2016 to Jun 2016
    • Eligibility criteria expanded, about 12 words
    • Primary completion date: Apr 2023 to Jun 2023
    • Site details revised
    • Study description expanded, about 1 word
  10. Start date: Dec 2015 to Apr 2016
    • Primary completion date: Dec 2022 to Apr 2023
    v5
  11. Primary completion date: Mar 2022 to Dec 2022
    • Start date: Mar 2015 to Dec 2015
    v4
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Maximum tolerated dose (MTD) of ceritinib and everolimus, defined as the highest dose level in which 6 patients were treated with at most 1 experiencing a dose limiting toxicity
Timeframe: 28 days

Secondary (3)

Response rate
Progression-free survival
Pharmacokinetic parameters of everolimus and ceritinib

Arms and interventions

Treatment (ceritinib, everolimus)Experimental

Patients receive ceritinib PO QD and everolimus PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drugs: Ceritinib, Everolimus

Other: Laboratory Biomarker Analysis, Pharmacological Study

Sites

1 site in 1 country

  • M D Anderson Cancer CenterHouston, Texas, United States