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Dose adjustment was permitted based upon tolerability and response criteria.
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The recommended phase-II dose of 52 68 mg m−2 was based upon clinical tolerability and the assessment of biological activity by means of PET and DCE MRI analysis.
Dose-response analyses tentatively indicate that an initial dosing level of 6.0 mg/kg per day administered orally in two daily intakes is the most appropriate, based upon potency and tolerability trends.
An evaluation of data collected from subjects who are treated in Arm I and Arm II will provide information about the appropriate starting dose of lithium in children/adolescents. Subjects randomized to Arms I and II may have their dose increased by 300 mg weekly, based upon response and tolerability.
Dose reductions of GMB and irinotecan were allowed based upon treatment tolerability.
The doses of ADX10059 were selected based upon the pharmacokinetic and tolerability data from a previous repeated dose study in healthy subjects (ref study ADX10059-102 data on file).
In summary, based upon its safety, tolerability profile, PK characteristics and potential antineoplastic activity in patients with advanced solid tumours, further evaluation of TAK-285 for the treatment of patients with solid tumours appears warranted.
Bortezomib doses were 1.0, 1.3, or 1.5 mg m−2, based on tolerability and efficacy in heavily pretreated patients with solid tumours.
An increase or decrease in dose was permitted based on tolerability and CGI-S scores assessed by investigators.
Concurrent CRT regimens have been based upon cisplatin and 5FU.
Cases were evaluated based upon presentation and age.
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