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Tyrosine

Erlotinib \& sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent Cytochrome P450, family 3 (CY3PA)-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.

Erlotinib \& sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of oral erlotinib and 5mg of oral sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of oral erlotinib and 10 mg of oral sirolimus for patients on concurrent EIAEDS.

Erlotinib + sirolimus

David Reardon, MD

Primary objective:

To determine the 6-month progression free survival of patients with recurrent glioblastoma multiforme (GBM) treated with Erlotinib plus Sirolimus.

Secondary objectives:

To further define the safety and tolerability of Erlotinib plus Sirolimus when administered to patients with recurrent GBM; and to evaluate progression free survival, radiographic response and overall survival of patients with recurrent GBM treated with Erlotinib plus Sirolimus.

The primary objective of this study will be to determine the 6-month progression free survival of patients with recurrent GBM treated with Erlotinib plus Sirolimus.

This is an exploratory, single-arm, phase II study designed to assess the anti-tumor activity of a combinatorial regimen consisting of Erlotinib plus Sirolimus among patients with recurrent GBM. The combinatorial regimen of Erlotinib plus Sirolimus is rationally designed to simultaneously inhibit upstream (EGFR) and downstream (mTOR) mediators of Phosphatidylinositide 3-kinase/Protein Kinase B (PI3/AKT) signaling. In a recently completed phase I study, we determined that an EGFR inhibitor (Gefitinib) can be safely combined with Sirolimus at dose levels that are routinely used in the monotherapy setting. Therefore, the primary endpoint of this study is the probability of progression-free survival at 6 months among recurrent GBM patients treated with standard doses of Erlotinib plus Sirolimus. An important secondary objective is to further assess the safety of Erlotinib and Sirolimus for patients with recurrent GBM.

Ph II Erlotinib + Sirolimus for Pts w Recurrent Malignant Glioma Multiforme

Phase II Trial of Erlotinib Plus Sirolimus for Patients With Recurrent Malignant Glioma Multiforme

Percentage of participants surviving six months from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of the first documented progression according to the Macdonald criteria, or death due to any cause. Progression based on Macdonald criteria is defined as a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration.

Time in weeks from the start of study treatment to the date of first progression according to Macdonald criteria, or to death due to any cause. Patients alive who had not progressed as of the last follow-up had PFS censored at the last follow-up date. Median PFS was estimated using a Kaplan-Meier curve. Progression based on Macdonald criteria is defined as a ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration.

Time in weeks from the start of study treatment to date of death due to any cause. Patients alive at last follow-up are censored as of that follow-up date. Median OS was estimated using a Kaplan-Meier curve.

Best radiographic response per modified Macdonald criteria. Complete response: disappearance of all enhancing tumor, no new lesions, and no steroids or only maintenance doses. Partial response: ≥ 50% reduction in the products of the perpendicular diameters of all enhancing lesions, no new lesions, \& steroids must be at a stable/decreasing dose. Stable disease: does not qualify for complete or partial response or progression \& is stable clinically. Progression: ≥ 25% increase in the sum of the products of perpendicular diameters of enhancing lesions, any new lesion or clinical deterioration.

Number of participants experiencing a ≥ grade 3, treatment-related, non-hematologic toxicity.

Genentech, Inc.

OSI Pharmaceuticals

Duke University

All adverse events were entered using Common Toxicology Criteria (CTC) v. 3.0, but were converted to CTC v. 4.0 for entry into ClinicalTrials.gov

Tarceva and Rapamycin

Erlotinib \& sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent CY3PA-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.

Erlotinib + Sirolimus

Age, Categorical

Age, Customized

Sex: Female, Male

Karnofsky Performance Scores (KPS) range from 0-100 (100=Normal, no complaints; no evidence of disease; 90=Able to carry on normal activity; minor signs or symptoms of disease; 80=Normal activity with efforts; some signs or symptoms of disease; 70=Cares for self; unable to carry on normal activity or to do active work. Scores between intervals are possible.

Karnofsky Performance Scale (KPS)

Received prior bevacizumab

Not receiving EIAEDs

Receiving EIAEDs

Enzyme-inducing anti-epileptic drug (EIAED) status

David A. Reardon, MD

6-month Progression-free Survival (PFS)

Median Progression Free Survival (PFS)

Median Overall Survival (OS)

Complete Response

Partial Response

Stable Disease

Progressive Disease

Not evaluable

Best Radiographic Response

Number of Participants Experiencing a ≥ Grade 3, Treatment-related, Non-hematologic Toxicity.

Erlotinib \& sirolimus on a daily dosing schedule on a 28-day cycle. Dosing was 150 mg of erlotinib and 5mg of sirolimus for patients not on concurrent Cytochrome P450, family 3, subfamily A (CY3PA)-inducing anti-epileptics (EIAEDS) and 400 mg of erlotinib and 10 mg of sirolimus for patients on concurrent EIAEDS.

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ph II Erlotinib + Sirolimus for Pts w Recurrent Malignant Glioma Multiforme	NCT00672243	Glioblastoma Gliosarcoma	Erlotinib + sir...	18 Years -	Duke University
Ph II Erlotinib + Sirolimus for Pts w Recurrent Malignant Glioma Multiforme	NCT00672243	Glioblastoma Gliosarcoma	Erlotinib + sir...	18 Years -	Duke University

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