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- W2589731912 abstract "2609 Background: Liposomal (LIPO) docetaxel (DOCE) formulations may reduce hypersensitivity reactions, eliminate premedication requirements, have a broader therapeutic index, and enhance systemic DOCE exposure. ATI-1123 is a novel LIPO DOCE formulation utilizing human serum albumin that facilitates LIPO tumor targeting. We studied safety, tolerability, pharmacokinetics (PK) and tumor response of ATI-1123 in patients (pts) with advanced solid tumors. Methods: Pts enrolled had progressive disease after standard therapy, measurable disease (RECIST), ECOG ≤ 2, survival ≥ 3 mo. Dosing (1 hr infusion) began at 15 mg/m2 using an accelerated titration design, followed by a modified Fibonacci schema to MTD. Dosing was continued until pts had progressive disease or unacceptable toxicities. Plasma was analyzed for encapsulated / non-encapsulated DOCE using a validated assay. PK was determined by model independent methods. Results: To date, 19 pts were enrolled (median age 62 yr; range 40-80 yr; 58% male; 5 (26%) NSCLC; 5 (26%) pancreas; 4 (21%) prostate; 3 (16%) other and 2 (11%) ovary. Doses studied (mg/m2) were 15 (2 pts), 30 (1 pt), 60 (3 pts), 90 (7 pts) and 110 (5 pts). Two DLTs were noted at the 110 mg/m2 cohort (Gr 3 mucositis; Gr 3 neutropenic fever) and the 90 mg/m2 cohort expansion is ongoing. At Cycle 1, 5 (26%) pts had hypersensitivity reactions (all Gr 2). One reaction required ATI-1123 discontinuation; the remainder were managed with test dose, prolonged infusion time and/or premedication. No new toxicities were noted relative to standard DOCE. PR was seen in 1 NSCLC pt. SD was noted in 4 of 9 pts (44%) for which protocol-defined followup was available (prostate, 2; pancreatic, 1; cervix, 1). Two prostate ca pts had pronounced PSA (>95% reduction) response following multiple treatment cycles. PK results demonstrated linear and dose proportional PK. Compared with standard DOCE PK Cmax and AUC0-24 ratios were 1.60-3.32 and 1.80-4.11 fold higher, and DOCE clearance was 1.68-4.10 fold lower with ATI-1123. Conclusions: ATI-1123 exhibited acceptable tolerability, a favorable PK profile and antitumor activity that warrant exploration in larger Phase 2 trials." @default.
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- W2589731912 date "2011-05-20" @default.
- W2589731912 modified "2023-09-27" @default.
- W2589731912 title "Phase I study of ATI-1123, a novel human serum albumin-stabilized docetaxel liposomal formulation, in patients with advanced solid malignancies." @default.
- W2589731912 doi "https://doi.org/10.1200/jco.2011.29.15_suppl.2609" @default.
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