NCT03275558

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Center Trials & Treatment · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Recurrent Glioblastoma
• Gliosarcoma
• Anaplastic Gliomas

Interventions

Type	Name	Description
DRUG	Axitinib 1 MG	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.
DRUG	Sunitinib 5 MG	Pharmaceutical composition of Axitinib 5MG +Sunitinib 5MG + Pazopanib 5MG in the liquid form of a nasal spray NST-4-G.
DRUG	Pazopanib 5 MG	Pharmaceutical composition of Axitinib 5MG +Sunitinib 5MG + Pazopanib 5MG in the liquid form of a nasal spray NST-4-G.

Timeline

• Start date: 2018-07-17
• Primary completion: 2018-07-17
• Completion: 2018-07-17
• First posted: 2017-09-07
• Last updated: 2018-07-19

Locations

2 sites across 2 countries: Hong Kong, Singapore