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A Phase I/II Study of Bexarotene in Combination With ZD1839 (IRESSA®) in the Treatment of Non-Small Cell Lung Cancer

StatusCompleted
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Enrollment target: estimated 12 to confirmed 6

    Study Status, Study Designv11

  2. Minor

    Study Status, Eligibility

    v10

  3. Notable

    Primary endpoints revised (4)

    Trial status: Terminated to Completed; Primary completion date: Apr 2005; Completion date: Dec 2005; and 1 more

    Show all 5 changes in this update
    • Notable Primary endpoints revised (4)
      Show what changed
      EstablishOverall safety/appropriateresponse dosingrate of(RECIST combinationCRITERIA), regimentime to progression, toxicity
    • Minor Trial status: Terminated to Completed
    • Minor Primary completion date: Apr 2005
    • Minor Completion date: Dec 2005
    • Minor Eligibility criteria revised
      Show what changed
      [...] the willingness to sign a written informed consent document
 Exclusion Criteria:- Insulin dependent diabetes Thyroid dis [...]

    Study Status, Sponsor/Collaborators, Study Design, Outcome Measures, Eligibilityv9

  4. Minor

    Eligibility criteria revised

    Show what changed: Eligibility criteria
    [...] n and marrow function as defined below: leukocytes >= 3,000/µlul absolute neutrophil count >= 1,500/µlul platelets >= 100,000/µlul total bilirubin within normal institutional limits AST(SGOT [...] the willingness to sign a written informed consent document
 Exclusion Criteria:- Insulin dependent diabetes Thyroid dis [...]

    Study Identification, Study Status, Eligibilityv8

  5. Notable

    Enrollment target: 6 to 12

    Eligibility criteria expanded, about 4 words; Study site revised; Collaborators: 1 to 2

    Show what changed: Eligibility criteria
    Inclusion Criteria:- Patients must have histologically or cytologically confirmed [...] has no significant side effects from the radiotherapy. Age ≥>= 18 years. Life expectancy > 2 months. ECOG performance statu [...] rmal organ and marrow function as defined below: leukocytes ≥>= 3,000/µl absolute neutrophil count ≥>= 1,500/µl platelets ≥>= 100,000/µl total bilirubin within normal institutional limits AST(SGOT)/ALT(SGPT) ≤<= 2.5 X institutional upper limit of normal creatinine within [...] mal institutional limits OR calculated creatinine clearance ≥>= 60 mL/min/1.73 m2 for patients with creatinine levels above [...] s [...]
    Show what changed: Study sites
    Stanford University CancerSchool Centerof Medicine
    Show what changed: Collaborators
    AstraZeneca

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Conditions, Study Design, Outcome Measures, Eligibility, Contacts/Locationsv7

Show 5 earlier versions

  1. Minor

    Study Status

    Re-verified, no change to tracked fields

    v6

  2. Minor

    Sponsor's reason: Research cancelled by pharmaceutical company.

    Enrollment target: 6; Start date: Apr 2004; Eligibility criteria shortened, about 30 words; and 1 more

    Show all 5 changes in this update
    • Minor Sponsor's reason: Research cancelled by pharmaceutical company.
    • Minor Enrollment target: 6
    • Minor Start date: Apr 2004
    • Minor Eligibility criteria shortened, about 30 words
      Show what changed
      Inclusion Criteria: 3.1.1 Patients must have histologically or cytologically confirmed [...] therapy regimen, or be intolerant of standard chemotherapy. 3.1.2 Patients may have non-measurable disease, or measurable dise [...] conventional techniques or as >10 mm with spiral CT scan). 3.1.3 Patients with asymptomatic or treated brain metastases will [...] elihood of rapid deterioration from their brain metastases. 3.1.4 Patients must have had at least 1 prior systemic therapy for [...] or therapy with bexarotene, ZD1839, or erlotinib (Tarceva). 3.1.5 At least 4 weeks must have elapsed from the time of major su [...] ve recover [...]
    • Minor Study title expanded, about 3 words
      Show what changed
      A Phase I/II Study of Bexarotene in Combination With ZD1839 (IRESSA®) in the Treatment of NSCLCNon-Small Cell Lung Cancer

    Study Identification, Study Status, Oversight, Study Description, Conditions, Study Design, Outcome Measures, Eligibilityv5

  3. Minor

    3 amendments

    3 re-verifications since 2006-06-13, no change to tracked fields

    v2-v4

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Stanford University
633 trials monitored
See 46 trials at risk
Lung Cancer
4,057 trials monitored
See 218 trials at risk
The purpose of Phase 1 of this study is to evaluate the safety of the combination regimen, bexarotene and ZD1839. Phase II will evaluate the median survival, time to disease progression, and toxicity.
Trial Details
NCT Number NCT00238628
Lead Sponsor Stanford University
Collaborators: Ligand Pharmaceuticals, AstraZeneca
Conditions Lung Cancer
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov