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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02189109




Registration number
NCT02189109
Ethics application status
Date submitted
19/05/2014
Date registered
14/07/2014
Date last updated
28/02/2019

Titles & IDs
Public title
The Effects of NVX-108 as a Radiation Sensitizer in Glioblastoma
Scientific 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
Secondary ID [1] 0 0
NVX108-GBM1B
Universal Trial Number (UTN)
Trial acronym
GBM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glioblastoma Multiforme 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NVX-108

Experimental: Dose Escalation - NVX-108 (DDFP liquid emulsion) i.v. in conjunction with Radiation Treatment and Temozolimide. 0.05-0.35cc/kg.


Treatment: Drugs: NVX-108
0.2% emulsion administered i.v.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
6 months
Secondary outcome [1] 0 0
Progression Free Survival at 6 months
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
1. Histologically-confirmed newly-diagnosed glioblastoma multiforme.
2. No prior treatment for glioblastoma apart from surgical resection.
3. No prior treatment for glioblastoma apart from surgical resection.
4. Planned for 60 Gray of focal radiation administered in 30 fractions, concurrently with temozolomide chemotherapy.
5. Manageable risks associated with potential radiation necrosis in the radiation field, based on size of the field and proximity to eloquent brain regions (as assessed by the investigator).
6. Aged 18-70 years.
7. ECOG performance status 0-2.
8. Life expectancy of at least 3 months.
9. If receiving glucocorticoid therapy, the dose must be stable over at least 7 days prior to study enrollment.
10. Archived tumor tissue available for central review.
11. Able to undergo gadolinium-enhanced MRI (Gd-MRI) scans.
12. Baseline MRI performed within 14 days before starting study treatment, while on a stable glucocorticoid dose for at least 5 days before and during the imaging study.
13. Adequate hematologic, renal and hepatic function, as defined by:

Absolute neutrophil count (ANC) = 1.5 109/L Platelet count = 100 109/L Hemoglobin = 90 g/L International normalized ratio (INR) and activated partial thromboplastin time (APTT) < 1.5 upper limit of normal (ULN) Plasma creatinine< 1.5 ULN Total bilirubin within normal limits (< 2.5 ULN if Gilbert's syndrome) AST and ALT < 2.5 ULN
14. Patients who are women of childbearing potential or men (unless vasectomised) must agree to use a highly-effective method of birth control, such as hormonal contraceptive implants, combined oral contraceptives, an intrauterine device, a double-barrier method (eg. condom with a diaphragm) or abstinence, from study entry until 4 months after completing study therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
15. Ability to understand and the willingness to sign a written informed consent document.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Presence of leptomeningeal disease or multifocal glioblastoma that cannot be encompassed within a feasible and safe radiation field.
2. Intracranial bleeding, except for stable grade 1 hemorrhage.
3. Has not recovered from the adverse effects of surgical resection or biopsy, except for neurological deficits.
4. Patients who have received any other investigational agent within 4 weeks before enrollment.
5. Stroke or transient ischemic attack within 6 months before enrollment.
6. Myocardial infarction within 6 months before enrollment, unstable angina, New York Heart Association class II or greater congestive heart failure, or uncontrolled hypertension (systolic BP > 160 mmHg and/or diastolic BP > 100 mmHg).
7. Congenital long QT syndrome.
8. Clinically-significant chronic obstructive pulmonary disease or asthma.
9. Active major infection requiring treatment.
10. A history of other malignancies, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer or other solid tumors curatively treated with no evidence of disease for = 2 years.
11. Known infection with human immunodeficiency virus or hepatitis B or C virus.
12. Current anticoagulant or antiplatelet therapy, except for prophylactic doses of low molecular weight heparins or low-dose aspirin.
13. History of allergic reactions attributed to compounds of similar chemical composition to NVX-108.
14. Women who are pregnant or breast feeding.
15. Inability to comply with study procedures.
16. History or evidence of any other clinically-significant condition that, in the opinion of the investigator, would pose a risk to subject safety or interfere with study procedures, evaluation or completion.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2018
Sample size
Target
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
St. Vincents Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
Flinders Medical Centre - Adelaide
Recruitment hospital [3] 0 0
Nucleus Network - Melbourne
Recruitment hospital [4] 0 0
Epworth Center - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
5042 - Adelaide
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
3121 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
NuvOx LLC
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Alfred
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02189109
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jason Lickliter, MBBSPhDFRACP
Address 0 0
Nucleus Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02189109