High-Dose,Pulsatile Erlotinib/Gefitinib for Advanced NSCLC Patients After Failure of Standard Dose EGFR-TKIs

Sponsor
Anhui Medical University
Study ID
NCT01965275
Phase
PHASE2
Status
Unknown

Conditions

  • Drug Toxicity
  • Self Efficacy

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Erlotinib or Gefitinib — DRUG
    Patients received the treatment with high-dose, pulsatile Erlotinib(600 mg every 4 days) or Gefitinib (1000 mg every 4 days) until disease progression or unacceptable toxicity occurred. The overall study period takes about 12 months

Study Details

the purpose of this study is to evaluate the efficacy and safety of high-dose，pulsatile Erlotinib/Gefitinib in advanced non small cell lung cancer (NSCLC) patients after failure of standard dose EGFR-TKIs（Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors）

Key Dates

First listed
Oct 18, 2013
Start date
Oct 31, 2013
Status verified
May 2017
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Erlotinib or Gefitinib
    Patients received the treatment with high-dose, pulsatile Erlotinib(600 mg every 4 days) or Gefitinib (1000 mg every 4 days) until disease progression or unacceptable toxicity occurred. The overall study period takes about 12 months

Primary Outcome Measure

efficacy and safety [ Time Frame: 1 year ]

Central Contacts

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