This phase 1 clinical trial is intended to understand the safety and tolerability of a new anticancer drug in subjects with advanced solid tumors. The patients who qualify for the study will receive a once daily dose of the drug taken by mouth and will undergo several tests to measure the drug in the blood and to understand the safety, tolerability and any effect of the drug on the tumor. The antitumor effect of the drug is not known in human.
Name: DS-2248
Description: Objective response rate = the sum of complete response [CR] and partial response [PR] rates
Measure: Objective response rate Time: Baseline to not more than 6 monthsDescription: Tumor response will be evaluated every 2 cycles using Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, if measurable tumors are available. Computed tomography (CT) and/or magnetic resonance imaging (MRI) should be used for tumor assessment unless another modality of disease assessment is necessary for the lesions.
Measure: Progression-free survival Time: Baseline to not more than 6 monthsDescription: The various pharmacokinetic parameters will be calculated from plasma concentrations of DS-2248 using non-compartmental analyses.
Measure: Study Part 1 - Determine the plasma pharmacokinetics of DS-2248 Time: Cycle 1 (Days 1, 2, 8, 15); Cycles 2, 3, (Days 1, 8, 15)Description: The various pharmacokinetic parameters will be calculated from plasma concentrations of DS-2248 using non-compartmental analyses.
Measure: Study Part 2 - Determine the plasma pharmacokinetics of DS-2248 Time: Day 1 for Cycle 3 and subsequent cyclesDescription: Disease control rate (DCR) = the sum of complete response rate, partial response rate, and stable disease (SD) rate for a minimum of 12 weeks
Measure: Disease control rate Time: Baseline to not more than 6 monthsAllocation: Non-Randomized
Single Group Assignment
There are 2 SNPs
- Either of the following: A tumor that harbors an EGFR mutation known to be associated with drug sensitivity (i.e., G719X, exon 19 deletion, L858R, L861Q) -OR- Prior objective clinical benefit from EGFR-TKI, as evidenced by complete response (CR), partial response (PR), or stable disease (SD) ≥6 months as defined by RECIST or World Health Organization criteria. --- L858R ---
- Either of the following: A tumor that harbors an EGFR mutation known to be associated with drug sensitivity (i.e., G719X, exon 19 deletion, L858R, L861Q) -OR- Prior objective clinical benefit from EGFR-TKI, as evidenced by complete response (CR), partial response (PR), or stable disease (SD) ≥6 months as defined by RECIST or World Health Organization criteria. --- L858R --- --- L861Q ---