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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03307629




Registration number
NCT03307629
Ethics application status
Date submitted
27/09/2017
Date registered
12/10/2017

Titles & IDs
Public title
Safety and Tolerability of NOX66 in Combination With Palliative Radiotherapy in Patients With Late-Stage Prostate Cancer
Scientific title
NOX66 and Palliative Radiotherapy in Patients With Late-Stage Prostate Cancer - a Phase 1b Proof of Concept and Dose Confirmation Study
Secondary ID [1] 0 0
NOX66-002A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NOX66
Treatment: Other - Irradiation Therapy

Experimental: NOX66 + Radiation treatment (combined) in cohorts 1-3 - NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle.

NOX66 treatment given to 3 cohorts of 4 patients as 1 of 3 doses, 400mg, 800mg and 1200 mg.

Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts.

Experimental: NOX66 + Radiation treatment (combined) in cohort 4 - NOX66 administered on Days 1-16 and radiation treatment given on Day 2 to 9 of 2-week cycle.

NOX66 dose will be either one of 3 doses 400mg, 800mg and 1200 mg based on interim analyses of safety data and tumour response at WEEK 6 of 3 dose cohorts of 12 total patients. The Safety Steering Committee will inform on dose for cohort expansion.

Radiation treatment of 20Gy given over 5 daily fractions to selected target lesion/s for all cohorts.


Treatment: Drugs: NOX66
NOX66 delivered as rectal suppository.

Treatment: Other: Irradiation Therapy
Radiation per selected tumour lesion.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change of incidence of Treatment-Emergent Adverse Events including SAEs [Safety and Tolerability] of NOX66 combined with radiation therapy between multiple timepoints
Timepoint [1] 0 0
Day 2, Day 6, EOT and from enrolment up to week 6, week 12, week 24
Primary outcome [2] 0 0
Assessment of laboratory results
Timepoint [2] 0 0
Screening, End of treatment (Day 16-17) and from enrolment up to week 6, week 12, week 24.
Primary outcome [3] 0 0
Assessment of ECG results
Timepoint [3] 0 0
Screening, End of treatment (Day 16-17) and from enrolment up to week 6, week 12, week 24.
Secondary outcome [1] 0 0
Change of tumour size in patients according to RECIST 1.1 criteria
Timepoint [1] 0 0
From enrolment up to week 6, week 12, week 24
Secondary outcome [2] 0 0
Change of non-target lesions according to RECIST 1.1 criteria
Timepoint [2] 0 0
From enrolment up to week 6, week 12, week 24
Secondary outcome [3] 0 0
Overall response according to RECIST 1.1 criteria
Timepoint [3] 0 0
From enrolment up to week 6, week 12, week 24
Secondary outcome [4] 0 0
Change in overall pain score assessment by using BPI-SF
Timepoint [4] 0 0
From enrolment up to week 6, week 12, week 18, week 24
Secondary outcome [5] 0 0
Increase or decrease of Prostate Specific Antigen (PSA) levels
Timepoint [5] 0 0
From enrolment up to week 6, week 12, week 24
Secondary outcome [6] 0 0
Change of ECOG value
Timepoint [6] 0 0
From enrolment up to week 6, week 12, week 24
Secondary outcome [7] 0 0
Assessment of change in physical appearance (physical exam) by measuring HEENT, gastrointestinal, abdominal status on multiple timepoints
Timepoint [7] 0 0
From enrolment up to Day 2, End of Treatment (day 16-17), week 6, week 12, week 24

Eligibility
Key inclusion criteria
1. Provision of informed consent
2. = 18 years of age
3. Histologically confirmed prostate cancer and/or PSA of >100 ng/mL at original diagnosis
4. Metastatic disease evidenced by either CT/MRI imaging or bone scan
5. Objective evidence of disease progression as defined by either:

i. Radiographic progression of in nodal or visceral metastases and bone disease progression with 2 or more new lesions ii. Rising PSA value =2ng/ml in at least 3 measurements, at least 1 week apart, with castrate levels of serum testosterone.
6. Eligible to receive palliative radiation therapy for management of disease
7. At least one symptomatic lesion which is suitable for radiation therapy
8. ECOG Performance status 0-2
9. A minimum life expectancy of 24 weeks
10. Adequate bone marrow, hepatic and renal function as evidenced by:

* Absolute neutrophil count (ANC) > 1.5 x 109/L
* Platelet count > 100 x 109/L
* Hemoglobin > 9.0 g/dL
* Serum bilirubin < 1.5 x ULN
* AST/ALT (SGOT/SGPT) < 2.5 x ULN for the reference laboratory or < 5 x ULN in the presence of liver metastases
* Serum creatinine < 1.5 x ULN
11. Ongoing androgen deprivation therapy with luteinizing hormone-releasing hormone (LHRH) agonist or antagonist
12. At least 4 weeks must have elapsed prior to commencement of NOX66 treatment since prior chemotherapy, investigational drug or biologic therapy and any toxicity associated with these treatments has recovered to = NCI-CTCAE (version 4.03) Grade 1.
13. At least 21 days must have elapsed following major surgery and any surgical incision should be completely healed.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Tumour involvement of the central nervous system
2. Uncontrolled infection or systemic disease
3. Clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease, angina, and cardiac arrhythmias) or myocardial infarction within the last 12 months

• Patients with a QTc > 470 msec on screening ECG
4. Concurrent systemic chemotherapy or biological therapy
5. Any situation where the use of suppository therapy is contra-indicated or impractical (eg. chronic diarrhoea, colostomy, ulcerative colitis).
6. Known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously treated or both)
7. Any subject whose testosterone is not suppressed i.e. is > 0.5nmols/L
8. Any other reason which, in the opinion of the investigator, will preclude suitable participation in the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Parallel
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
1/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/09/2020
Sample size
Target
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Genesis Cancer Care - Newcastle - Newcastle
Recruitment hospital [2] 0 0
Central West Cancer Care Centre - Orange Health Service - Orange
Recruitment hospital [3] 0 0
Genesis Cancer Care Mater Hospital - Sydney
Recruitment hospital [4] 0 0
North West Cancer Centre, Tamworth Hospital - Tamworth
Recruitment hospital [5] 0 0
Radiation Oncology Centres Gold Coast - Gold Coast
Recruitment postcode(s) [1] 0 0
2290 - Newcastle
Recruitment postcode(s) [2] 0 0
2800 - Orange
Recruitment postcode(s) [3] 0 0
2060 - Sydney
Recruitment postcode(s) [4] 0 0
2340 - Tamworth
Recruitment postcode(s) [5] 0 0
4215 - Gold Coast
Recruitment outside Australia
Country [1] 0 0
Georgia
State/province [1] 0 0
Tbilisi
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Noxopharm Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marinella Messina, PhD
Address 0 0
Noxopharm Limited
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data for primary and secondary outcome measure will be made available within 12 months after study completion.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
12 months after study completion
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03307629