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mTORC1/mTORC2 Kinase Inhibitor AZD2014 in Previously Treated Glioblastoma Multiforme

2015-12-03 01:08:23 | BioPortfolio

Summary

The standard or usual treatment for this disease is standard chemotherapy alone. For the first part of this study (phase I), there are two purposes. The first is to see whether AZD2014 can affect glioblastoma multiforme, and the second purpose is to see what effects it has.

Description

To do this, participants will receive AZD2014 alone for 2 days at doses the investigators know are safe from other studies, just before planned surgery to remove the cancer. After participants have recovered from surgery, they will start AZD2014 again. For this part of the study the purpose is to find the highest dose of AZD2014 that can be tolerated without causing very severe side effects when receiving temozolomide therapy and to see what effects the study drugs have on the participant and their cancer. This is done by starting at a dose lower than the one that investigators know can be given safely to patients when used on its own. Participants are given AZD2014 together with temozolomide and will be watched very closely to see what side effects they have and to make sure the side effects are not severe. If the side effects are not severe, then new participants will be given a higher dose of AZD2014. Participants joining this study later on will get higher doses of AZD2014 than participants who join earlier. This will continue until a dose is found that causes severe but temporary side effects. Doses higher than that will not be given.

The researchers doing this study are also interested in looking for markers that will help predict which patients are most likely to be helped by AZD2014.

For the second phase of this study (phase II), the purpose is to find out the effects that AZD2014 has on participants and their glioblastoma, using doses found to be safe in the first part of the study, when given with temozolomide.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Glioblastoma Multiforme

Intervention

AZD2014

Status

Not yet recruiting

Source

NCIC Clinical Trials Group

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-12-03T01:08:23-0500

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Medical and Biotech [MESH] Definitions

Benign and malignant central nervous system neoplasms derived from glial cells (i.e., astrocytes, oligodendrocytes, and ependymocytes). Astrocytes may give rise to astrocytomas (ASTROCYTOMA) or glioblastoma multiforme (see GLIOBLASTOMA). Oligodendrocytes give rise to oligodendrogliomas (OLIGODENDROGLIOMA) and ependymocytes may undergo transformation to become EPENDYMOMA; CHOROID PLEXUS NEOPLASMS; or colloid cysts of the third ventricle. (From Escourolle et al., Manual of Basic Neuropathology, 2nd ed, p21)

A skin and mucous membrane disease characterized by an eruption of macules, papules, nodules, vesicles, and/or bullae with characteristic "bull's-eye" lesions usually occurring on the dorsal aspect of the hands and forearms.

A variant of bullous erythema multiforme. It ranges from mild skin and mucous membrane lesions to a severe, sometimes fatal systemic disorder. Ocular symptoms include ulcerative conjunctivitis, keratitis, iritis, uveitis, and sometimes blindness. The cause of the disease is unknown.

A malignant form of astrocytoma histologically characterized by pleomorphism of cells, nuclear atypia, microhemorrhage, and necrosis. They may arise in any region of the central nervous system, with a predilection for the cerebral hemispheres, basal ganglia, and commissural pathways. Clinical presentation most frequently occurs in the fifth or sixth decade of life with focal neurologic signs or seizures.

Condition characterized by large, rapidly extending, erythematous, tender plaques on the upper body usually accompanied by fever and dermal infiltration of neutrophilic leukocytes. It occurs mostly in middle-aged women, is often preceded by an upper respiratory infection, and clinically resembles ERYTHEMA MULTIFORME. Sweet syndrome is associated with LEUKEMIA.

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