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Report for Clinical Trial NCT01513174
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
This is a study of gefitinib plus olaparib gefitinib in combination with olaparib (AZD2281)
versus gefitinib alone, in patients with Epidermal Growth Factor Receptor (EGFR) mutation
positive advanced non-small-cell lung cancer.
Name: Gefitinib
Description: Gefitinib 250 mg once a day, continuously, in 28-day cycles, until progression
Type: Drug
Group Labels: 1 Gefitinib
Name: Gefitinib plus olaparib
Description: Gefitinib 250 mg once a day, in combination with olaparib (at the recommended dose in the previous Phase Ib study) twice a day, continuously, in 28-day cycles.
Type: Drug
Group Labels: 1 Gefitinib in combination with olaparib
Primary Outcomes
Measure: MTD (Maximum Tolerated Dose) defined as the highest dose level at which < 2 out of 6 patients experience a DLT Time: 5 weeks
Secondary Outcomes
Measure: Progression-free survival Time: An expected average of 2 years
Measure: Overall response rate Time: An expected average of 2 years
Measure: Overall survival Time: An expected average of 2 years
Measure: Peak Plasma Concentration Time: Predose, half an hour, 1, 2, 4, 6 and 12 hours post-dose
Purpose: Treatment
Allocation: Randomized
Parallel Assignment
There are 2 SNPs
SNPs
1 L858R
4. Tumor tissue available (according to the criterion of the specimen-processing
laboratory) for EGFR mutation assessment: to be included in the study patients should
present at least one EGFR mutation (exon 19 deletion or L858R with or without T790M). --- L858R ---
4. Tumor tissue available (according to the criterion of the specimen-processing
laboratory) for EGFR mutation assessment: to be included in the study patients should
present at least one EGFR mutation (exon 19 deletion or L858R with or without T790M). --- L858R --- --- T790M ---