Quinoline derivative for treating non-small cell lung cancer
A non-small cell lung cancer and drug technology, applied in the field of medicine, can solve the problems of treatment differences in NSCLC patients
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Embodiment 11
[0058] Example 1 1-[[[4-(4-Fluoro-2-methyl-1H-indol-5-yl)oxy-6-methoxyquinolin-7-yl]oxy]methyl] Cyclopropylamine dihydrochloride
[0059]
[0060] 1-[[[4-(4-Fluoro-2-methyl-1H-indol-5-yl)oxy-6-methoxyquinolin-7-yl was prepared by referring to the method of Example 24 in WO2008112407 ]oxy]methyl]cyclopropylamine, followed by the preparation of the salt form examples in the specification to prepare the title compound.
Embodiment 21
[0061] Example 2 1-[[[4-(4-Fluoro-2-methyl-1H-indol-5-yl)oxy-6-methoxyquinolin-7-yl]oxy]methyl] Preparation of capsules of cyclopropylamine dihydrochloride (dihydrochloride of compound I)
[0062]
[0063]Pulverize the dihydrochloride of compound I, pass through an 80 mesh sieve; then mix with mannitol and hydroxypropyl cellulose; then add the microcrystalline cellulose of the recipe quantity, mix well, pass through a 0.8mm sieve; finally add the recipe quantity of magnesium stearate, mix well and fill the capsules.
Embodiment 3
[0065] Randomized, randomized, pathologically confirmed patients with measurable disease, pathologically confirmed advanced non-small cell lung cancer, second-line or higher therapy or intolerable, and receiving other cytotoxic drugs, radiotherapy, or surgery for more than four weeks Double-blind, placebo-controlled, multicenter Phase II clinical trial study. In this study, the efficacy of compound I dihydrochloride capsules in the treatment of advanced non-small cell lung cancer was preliminarily evaluated compared with placebo. The primary outcome measure was progression-free survival (PFS). Of the 117 patients enrolled in the study, 57 were randomized to the placebo group and 60 to the hydrochloride group, aged 18-70 years.
[0066] The above-mentioned eligible non-small cell lung cancer patients received Compound I dihydrochloride / placebo for clinical trials. The dose of 12 mg / 0 mg once a day, continuous medication for 2 weeks and then 1 week off, that is, 3 weeks (21 da...
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