None listed
Conditions
Brief summary
This is a study of an experimental oral anti-cancer drug called CYT997, given every two weeks, to people with advanced cancer. You may be eligible to join this study if you have an advanced solid tumour cancer and a life expectancy of more than three months. CYT997 is an experimental anti-cancer agent which targets the blood supply to the tumour. Participants will receive CYT997 as an oral capsule dose on a two weekly cycle for up to six cycles. Most advanced cancers will eventually stop responding to cancer treatments. In this situation, for people who may be eligible for this drug trial, there may not be any alternative standard treatments. Participants will receive supportive care and symptomatic treatments during the trial, in addition to receiving CYT997. The major focus of this trial is to test the safety of CYT997 when given orally every 2 weeks. The trial also aims to assess the effect (good and bad) that CYT997 may have on you and your cancer. This involves finding out the highest dose of CYT997 that can be given without causing severe side effects. This is a study of an experimental oral anti-cancer drug called CYT997, given every two weeks, to people with advanced cancer. You may be eligible to join this study if you have any sort of solid cancer and a life expectancy of greater than three months. Participants receive oral capsules of CYT997, which is an experimental anti-cancer agent which targets the blood supply to the cancer. This trial aims to determine the safety and tolerability of CYT997 when given as an oral capsule dose on a two weekly cycle for up to six cycles. Most advanced cancers will eventually stop responding to cancer treatments. In this situation, there may not be an alternate standard treatment for people who may be suitable for this drug trial. Participants will receive supportive care and symptomatic treatments during the trial in addition to CYT997. This trial aims to find a maximum safe dose, and determine any side effects of CYT997 given orally every 2 weeks.
Interventions
CYT997 administered as an oral capsule dose on a two weekly cycle for up to six cycles. The starting dose is 15mg/m2 and the dose escalates at 1.4x the previous dose. Dose escalation may occur every two weeks (ie at the completion of the first cycle for each successive patient in the dose-escalation phase). Dose-escalation will cease at the occurrence of drug-related Grade 4 neutropenia lasting 5 days or longer or associated with fever requiring antibiotics; Grade 4 thrombocytopenia or non-haema
CYT997 administered as an oral capsule dose on a two weekly cycle for up to six cycles. The starting dose is 15mg/m2 and the dose escalates at 1.4x the previous dose. Dose escalation may occur every two weeks (ie at the completion of the first cycle for each successive patient in the dose-escalation phase). Dose-escalation will cease at the occurrence of drug-related Grade 4 neutropenia lasting 5 days or longer or associated with fever requiring antibiotics; Grade 4 thrombocytopenia or non-haematological toxicity of Grade 3 or greater (excluding nausea, vomiting and diarrhoea with optimal treatment).
Sponsors
Cytopia Research 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 No maximum
Healthy volunteers
No
Inclusion criteria
(i) Confirmed solid malignancy; (ii) Life-expectancy of greater than 3 months; (iii) No anticancer chemotherapy or hormonal therapy for the preceding 4 weeks; (iv) Adequate organ and marrow function.
Exclusion criteria
(i) Patients must not have received other experimental agents in preceding 4 weeks; (ii) Known brain metastases; (iii) Patients with various cardiovascular risk factors are excluded; (iv) Pregnancy and immune deficiency.
Outcome results
None listed