Table 3.
Summary of large surface area microparticle docetaxel (LSAM-DTX) suspension concentrations and total dose administered for the high-risk non-muscle invasive bladder cancer study. Adapted with permission from [12]
| Direct-injection LSAM-DTXa | Intravesical LSAM-DTXb | |||||
|---|---|---|---|---|---|---|
| Cohort | n | Conc. of injection suspension (mg/mL) |
Total LSAM-DTX delivered (mg) (mean, range) |
Conc. of inductionc, maintenanced suspension (mg/mL) |
No. of instillations (mean; range) |
Total LSAM-DTX delivered (mg) (mean; range) |
| 1 | 4 | 0.75 | 3.00 | 2.00, 3.00 | 10 | 645 (630–650) |
| 2 | 3 | 1.50 | 4.50 (3.75–6.00) | 2.00, 3.00 | 9 (7–10) | 625 (510–714) |
| 3 | 3 | 2.50 | 7.92 (6.25–10.00) | 2.00, 3.00 | 9 (7–10) | 575 (425–650) |
| 4 | 3 | 3.75 | 15.00 | 2.00, 3.00 | 9 (8–10) | 600 (500–650) |
| Expansion | 6 | 3.75 | 14.06 (9.38–15.00) | 3.00e, 3.00 | 10 | 746 (725–750) |
aDirect injection of LSAM-DTX into the index tumor resection site on the bladder wall occurred once immediately following transurethral resection of bladder tumor (TURBT)
bIntravesical administrations of LSAM-DTX occurred up to 10 times: once within 2 h of the TURBT/direct injection and up to 9 times during the induction and maintenance phases
cInduction phase was initiated ≥ 4 weeks post-TURBT and included once weekly instillations for up to 6 weeks
dMaintenance phase was initiated ≥ 7 weeks after the start of the induction phase and included once weekly intravesical administration for up to 3 weeks
eOne subject received a single maintenance intravesical therapy cycle at 2.00 mg/mL LSAM-DTX