Table 2.
Dose escalation scheme
| Cohort number | Number of patients | Zosuquidar 3HCl dose (n*) | Time between zosuquidar 3HCl doses (h) | Paclitaxel dose (mg m−2) given on day X of the cycle x hour after the nthzosuquidar 3HCl dose |
|---|---|---|---|---|
| 1 | 9 | 100 mg m−2 (10) | 8 | 175 on day 3, 2 h (7th) |
| 2 | 3 | 200 mg m−2 (7) | 12 | 175 on day 3, 2 h (5th) |
| 3 | 4 | 300 mg m−2 (7) | 12 | 175 on day 3, 2 h (5th) |
| 4 | 8 | 300 mg m−2 (3**) | 12 | 175 on day 1, 0.5 h (2nd) |
| 5 | 7 | 250 mg m−2 (3) | 12 | 175 on day 1, 0.5 h (2nd) |
| 6 | 3 | 450 mg (2) | 12 | 225 on day 1, 1 h (1st) |
| 7 | 9 | 500 mg (2+) | 12 | 225++ on day 1, 1 h (1st) |
*
n, total number of doses of zosuquidar 3HCl administered in cycle1;
**
only 2 doses for id 153, 250; +only 1 dose for id 200; ++175 mg m−2 for id 165, 166 and 256. From cycle 1 to cycle 2, five patients had their paclitaxel dose reduced (1 from 225 to 175 mg m−2 and 4 from 175 to 135 mg m−2).