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AP23573

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.

Safety Study of AP23573 in Patients With Progressive or Recurrent Glioma (8669-023)(COMPLETED)

A Phase I Sequential Ascending Dose Trial of AP23573 in Patients With Progressive or Recurrent Malignant Glioma

Ariad Pharmaceuticals

Merck Sharp & Dohme LLC

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety Study of AP23573 in Patients With Progressive or Recurrent Glioma (8669-023)(COMPLETED)	NCT00087451	Malignant Gliom... Glioblastoma Gliosarcoma	AP23573	18 Years -	Merck Sharp & Dohme LLC
Safety Study of AP23573 in Patients With Progressive or Recurrent Glioma (8669-023)(COMPLETED)	NCT00087451	Malignant Gliom... Glioblastoma Gliosarcoma	AP23573	18 Years -	Merck Sharp & Dohme LLC

Spots Global Cancer Trial Database for progressive or recurrent malignant glioma