Glioblastoma Clinical Trial
Official title:
A Phase I Sequential Ascending Dose Trial of AP23573 in Patients With Progressive or Recurrent Malignant Glioma
A Phase I, open-label, non-randomized, sequential dose escalation cohort trial of the safety, tolerability, and maximum tolerated dose (MTD) of AP23573 when administered intravenously as a 30-minute infusion, once daily for five days, repeated every two weeks, to patients with progressive or recurrent malignant glioma.
The primary objective of the study is to determine the safety, tolerability, and maximum
tolerated dose (MTD) of AP23573 when administered intravenously once daily for five days
repeated every two weeks to patients with progressive or recurrent gliomas who have failed
standard therapy and who are or are not receiving enzyme-inducing anticonvulsant (EIAC)
medications.
The secondary objectives are to: characterize the pharmacokinetic profile of AP23573 when
administered daily for five days repeated every two weeks at the indicated dosage levels in
patients receiving and not receiving EIAC; describe the progression-free survival at six
months; describe changes in proteins affected by mTOR inhibition; describe single timepoint
status of proteins affected by mTOR inhibition in tumor tissue surgical specimens after
AP23573 dosing; describe the status of key proteins in the mTOR signaling pathway in
archival tumor samples, if available; describe health-related quality of life at the start
of the trial and prior to study drug infusion and at various timepoints throughout the
trial.
Protocol Outline:
This is a Phase I, open-label, non-randomized, sequential dose escalation cohort trial of
the safety, tolerability, and MTD of AP23573 when administered intravenously as a 30-minute
infusion, once daily for five days, repeated every two weeks, to patients with progressive
or recurrent malignant glioma.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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