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Images were rated suboptimal or nondiagnostic more often in the intermediate dose level (p < 0.05) but not in the final.
For 16-MDCT, the original and intermediate dose level quality reference mAs was 200, and weight-based (1 pound [0.45 kg] = 1 mAs) for the final dose level.
An intermediate dose level of 85 mg was studied.
Responses were observed at the intermediate dose level of 15 mg/m daily × 10 days (150 mg/m/course).
The protocol was then modified to require more aggressive post-BMTP-11 forced diuresis and was reopost-BMTP-11 forcedan post-BMTP-11 forcedevel (27 mg/m).
As the previous dose level (1.8 mg m−2) was not associated with any significant toxicity, an intermediate dose level (3.0 mg m−2) was explored.
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No significant haematological toxicity occurred at either of these intermediate dose levels.
Three further intermediate dose levels (L1b, L2b, L3b), are also provided in case MTD is reached.
Dose levels for the study were predefined as in Figure 1; however, intermediate dose levels were allowed.
Provision was made in the protocol for intermediate dose levels or expansion of a dose cohort to define better the dose toxicity relationship of XR5944.14.
Subsequent cohorts of patients were treated at intermediate dose levels of 170 and 200 mg m−2 in order to define a safe dose for phase 2 studies.
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