The Effects of NVX-108 as a Radiation Sensitizer in Glioblastoma (GBM)
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|ClinicalTrials.gov Identifier: NCT02189109|
Recruitment Status : Unknown
Verified September 2016 by NuvOx Pharma Pty Ltd.
Recruitment status was: Active, not recruiting
First Posted : July 14, 2014
Last Update Posted : September 26, 2016
This clinical trial is testing the safety, tolerability and effectiveness of NVX-108 administered via intravenous infusion in combination with standard radiation and chemotherapy.
NVX-108 is being developed to increase the amount of oxygen delivered to tumors which is hoped to increase the effectiveness of radiation therapy.
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme||Drug: NVX-108||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b Dose-finding, Pharmacokinetic and Pharmacodynamic Study of NVX-108 Combined With Radiation and Temozolomide in Patients With Newly-diagnosed Glioblastoma Multiforme|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||December 2017|
Experimental: Dose Escalation
NVX-108 (DDFP liquid emulsion) i.v. in conjunction with Radiation Treatment and Temozolimide. 0.05-0.35cc/kg.
0.2% emulsion administered i.v.
Other Name: Dodecafluoropentane
- Safety and Tolerability of NVX-108 in Combination with Radiation and Temozolomide Defined by no Drug related Adverse Events (AE) in No More than 1 Patient per Treatment Group [ Time Frame: 6 months ]Adverse Events are considered to be neurological and hemodynamic
- Progression Free Survival at 6 months [ Time Frame: 6 months ]
- Tumor Reduction Based on Gd-MRI [ Time Frame: 4 months ]First determination will be measured at 4 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189109
|Australia, New South Wales|
|St. Vincents Hospital Sydney|
|Darlinghurst, New South Wales, Australia, 2010|
|Australia, South Australia|
|Flinders Medical Centre|
|Adelaide, South Australia, Australia, 5042|
|Melbourne, Victoria, Australia, 3004|
|Melbourne, Victoria, Australia, 3121|
|Principal Investigator:||Jason Lickliter, MBBSPhDFRACP||Nucleus Network|