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Axitinib

Sunitinib

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A single dose of Axitinib - 1 mg in a liquid form in the composition (Axitinib+Sunitinib+Pazopanib) of the nasal spray.

A single dose of Sunitinib- 5 mg in a liquid form in the composition (Axitinib+Sunitinib+Pazopanib) of the nasal spray.

A single dose of Pazopanib-5 mg in a liquid form in the composition (Axitinib+Sunitinib+Pazopanib) of the nasal spray.

Pharmaceutical composition of Axitinib 5MG +Sunitinib 5MG + Pazopanib 5MG in the liquid form of a nasal spray NST-4-G.

Subjects take a nasal spray BID at a single dose in each nostril (approximately at the same time of day) for 7 weeks or unacceptable toxicity or other adverse events.

Axitinib 1 MG

Pharmaceutical composition of Axitinib 5MG +Sunitinib 5MG + Pazopanib 5MG in the liquid form of a nasal spray NST-4-G.

Sunitinib 5 MG

Pazopanib 5 MG

Ivo Reznic, PhD

Oliever R Kolb

This is a study to determine the efficacy, safety and clinical benefit (how well the drugs works), of the pharmaceutical compositions in Nasal Spray NST-4G for the treatment of brain tumors( Recurrent Glioblastoma, Gliosarcoma,Anaplastic Gliomas, Previously Treated).

All drugs target the inhibition of the growth factors and neo-angiogenesis as one the main reasons for the growth of the tumor.

The purpose of the Nasal Spray NST-4G study is to determine the safety and tolerability in order to establish the best dose level to be used in future studies.

This is an open-label study, Phase 1 study evaluating the preliminary safety, efficacy, tolerability and clinical benefit of Nasal Spray NST-4G in patients with Recurrent Glioblastoma, Gliosarcoma,Anaplastic Gliomas.

Acceptable subjects included in the study will receive Nasal Spray NST-4G, administered twice daily for 7 weeks intranasally.

Every 8th day, a blood function (hematopoiesis) is examined . Patients may continue to receive subsequent nasal spray cycles if the subject is not intolerant of the test product, does not withdraw consent or the individual no longer receives clinical benefit (the factors taken for consideration will be the progression of the disease, expressed in increasing neuropathy, hemiparesis, pain intensification ,DLT events, Clinical signs of deteriorating quality of life (QOL).

The evaluation of the tumor size will be repeated using the MRI method with a contrast agent after each 7-week nasal spray cycle.

The use of nasal spray is a non-invasive method of treatment that does not require specialized conditions for therapy

Clinical Trial of the Use of the Nasal Spray of Patients With Recurrence of Glioblastoma

Phase I Clinical Trial of Nasal Spray in Treating Patients With Recurrent Glioblastoma, Gliosarcoma, Glioma

The definition of survival without progression of disease is estimated as time of the disease-free period / absence of continued tumor growth (in weeks) by objective methods of control (MRI or CT)

The determine overall survival from the date of commencement of participation in the study until date of death from any cause.

To determine late toxicity for the maximum tolerated dose is estimated a function of hematopoiesis of patients by blood sampling every 8th day The MTD is based upon dose-limiting toxicities (DLTs) experienced during Cycle 1 of treatment. The MTD is the dose level at which 0/6 or 1/6 patients experience DLT with at least two patients experiencing DLT at the next higher dose level. Using Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, DLTs are defined as: Grade 4 neutropenia lasting greater than 5 days; Grade 3 thrombocytopenia; the occurrence of non-hematologic Grade 3 or greater drug-related adverse events excluding Grade ≥ 3 elevation in alkaline phosphatase, Grade ≥ 3 nausea or vomiting unless occurring despite the use of standard anti-emetics or Grade 3 diarrhea unless occurring despite standard anti-diarrheal therapy; \> 14 day delay to re-treat due to failure to resolve drug-related toxicity to re-treatment criteria or pre-treatment baseline.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clinical Trial of the Use of the Nasal Spray of Patients With Recurrence of Glioblastoma	NCT03275558	Recurrent Gliob... Gliosarcoma Anaplastic Glio...	Axitinib 1 MG Sunitinib 5 MG Pazopanib 5 MG	18 Years - 80 Years	Center Trials & Treatment
Clinical Trial of the Use of the Nasal Spray of Patients With Recurrence of Glioblastoma	NCT03275558	Recurrent Gliob... Gliosarcoma Anaplastic Glio...	Axitinib 1 MG Sunitinib 5 MG Pazopanib 5 MG	18 Years - 80 Years	Center Trials & Treatment

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