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• W2890103368 abstract "e20578 Background: NAPA is an oral investigational agent, hypothesized to inhibit cancer stemness pathways, including the STAT3 pathway implicated in cancer stem-cell viability. A clinical trial evaluated NAPA + PTX and a cohort for patients (pts) with advanced, previously treated thymoma and thymic carcinoma was opened. Methods: This is an open-label, multicenter study (NCT01325441) of NAPA + PTX for advanced, previously treated thymoma and thymic carcinoma. Objectives were safety and evaluation of antitumor activity. Pts received NAPA 240 or 480 mg BID + PTX 80 mg/m2IV weekly for 3 of every 4 wks. Tumor assessments were every 8 wks per RECIST 1.1. Data cut-off was Jan 2018. Results: From Aug 2015 to Dec 2017, 16 pts (6 thymic carcinoma, 10 thymoma) enrolled. All pts received prior therapy (avg 2.5 regimens; range 1 – 6) and 3 had prior taxane. Median treatment duration was 26 wks (range 2 to 62), excluding 4 pts still on therapy. Grade 3 AEs included: diarrhea 13%; vomiting 6%; and abdominal pain 7%. There were 2 deaths on study not thought to be treatment related (perforated bowel, autoimmune myocarditis; both in thymoma patients). In 6 pts with thymic carcinoma, 4 had partial response (PR) and 1 had stable disease (SD). The objective response rate (ORR) was 67%; the disease control rate (DCR, % with CR, PR, or SD) was 83%. One pt. remained on treatment without progression (PD) at 10 wks and 5 pts (83%) have discontinued (PD [3], investigator decision [1], pt request [1]). The proportion alive without PD at 24 wks was 60% (3 of 5) excluding 1 pt on active treatment < 24 wks without PD. In 10 pts with thymoma, 2 had PR and 3 had SD out of 8 with imaging (2 had not yet reached 1st imaging timepoint). The ORR was 25% and DCR was 63%. Three pts (30%) remained on treatment without PD at 6 wks, 6 wks, and 18 wks, respectively. The proportion alive without PD at 24 weeks was 43% (3 of 7), excluding the pts who were on treatment < 24 wks without PD. Conclusions: In a heavily pretreated population of pts with advanced thymic carcinoma and thymoma, NAPA + PTX demonstrated clinical activity and reasonable clinical safety. Further clinical evaluation of the combination regimen is warranted in this population, particularly in thymic carcinoma. Clinical trial information: NCT01325441." @default.
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• W2890103368 date "2018-05-20" @default.
• W2890103368 modified "2023-09-23" @default.
• W2890103368 title "A phase 1b study of napabucasin (NAPA) + weekly paclitaxel (PTX) in patients (pts) with advanced thymoma and thymic carcinoma." @default.
• W2890103368 doi "https://doi.org/10.1200/jco.2018.36.15_suppl.e20578" @default.
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