None listed
Conditions
Brief summary
The study investigated the pharmacokinetics of phenoxodiol given as an intravenous bolus and a continuous intravenous infusion in a first-in-human study, to patients with advanced cancer.
Interventions
ntravenous phenoxodiol was given to cancer patients in two schedules: bolus (5mg/kg) and continuous infusion (2mg/kg/hr) up to 10 half-lives determined from the bolus infusion part of the study. The infusion was given 41-98 days after the bolus dose.
Sponsors
Novogen Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Male or females with metastatic disease from any solid tumour, age 18 to 70 years, normal haematological parameters and the provision of signed informed consent
Exclusion criteria
Leukemia or lymphoma, allergy to soy products, vegetarian diet or use of soy product more than three times a week, the use of sex steroids in the previous two months, antibiotic therapy within one month prior to the study period or at any time during the study, smoking of greater than 10 cigarettes/day, a prognosis of at least three months, and the known presence of central nervous system metastases, active infection or other co-morbid disease
Outcome results
None listed