Status:
COMPLETED
Safety and Tolerability of NOX66 in Combination With Palliative Radiotherapy in Patients With Late-Stage Prostate Cancer
Lead Sponsor:
Noxopharm Limited
Conditions:
Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
The study is intended as a Proof of Concept and dose confirmation study. The primary objective of this study is to observe safety and tolerability of idronoxil (NOX66) in combination with radiotherapy...
Detailed Description
This study will investigate three escalating doses of NOX66 in combination with palliative dose of radiation therapy to establish safety profile and / or obtain efficacy signals and to determine the o...
Eligibility Criteria
Inclusion
- Provision of informed consent
- ≥ 18 years of age
- Histologically confirmed prostate cancer and/or PSA of \>100 ng/mL at original diagnosis
- Metastatic disease evidenced by either CT/MRI imaging or bone scan
- 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.
- Eligible to receive palliative radiation therapy for management of disease
- At least one symptomatic lesion which is suitable for radiation therapy
- ECOG Performance status 0-2
- A minimum life expectancy of 24 weeks
- 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
- Ongoing androgen deprivation therapy with luteinizing hormone-releasing hormone (LHRH) agonist or antagonist
- 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.
- At least 21 days must have elapsed following major surgery and any surgical incision should be completely healed.
Exclusion
- Tumour involvement of the central nervous system
- Uncontrolled infection or systemic disease
- 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
- Concurrent systemic chemotherapy or biological therapy
- Any situation where the use of suppository therapy is contra-indicated or impractical (eg. chronic diarrhoea, colostomy, ulcerative colitis).
- Known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously treated or both)
- Any subject whose testosterone is not suppressed i.e. is \> 0.5nmols/L
- Any other reason which, in the opinion of the investigator, will preclude suitable participation in the study.
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2020
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03307629
Start Date
November 1 2017
End Date
September 15 2020
Last Update
July 29 2025
Active Locations (10)
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1
Genesis Cancer Care - Newcastle
Newcastle, New South Wales, Australia, 2290
2
Central West Cancer Care Centre - Orange Health Service
Orange, New South Wales, Australia, 2800
3
Genesis Cancer Care Mater Hospital
Sydney, New South Wales, Australia, 2060
4
North West Cancer Centre, Tamworth Hospital
Tamworth, New South Wales, Australia, 2340