CompletedPhase 1ACTRN12605000793617
Phase I dose-escalation study for CYT997
Phase I dose-escalation study of CYT997 given as a 24-hour intravenous infusion every three weeks in patients with advanced solid tumours
Sponsor
Cytopia Research Pty Ltd
Enrollment
24 participants
Start Date
Jun 14, 2005
Study Type
Interventional
Conditions
Summary
CYT997 is an experimental anticancer agent with vascular targetting activity. This Phase I trial aims to determine the safety and tolerability of CYT997 when given as a 24-hour intravenous infusion.
Eligibility
Sex: Both males and femalesMin Age: 18 Yearss
Inclusion Criteria1
- (i) Patients must have solid malignancy that is metastatic or unresectable and for which standard curative or palliative anti-neoplastic treatments do not exist or are no longer effective.(ii) Life-expectancy of greater than 3 months(iii) No anti-cancer chemotherapy or hormonal therapy for the preceding 4 weeks(iv) Patients must have adequate organ and marrow function(v) Willing to give informed consent.
Exclusion Criteria1
- (i) Patients must not have received other investigational agents within the preceding 4 weeks(ii) Patients with known brain metastases are excluded from the trial(iii) As CYT997 may have vascular targetting activity, patients with various cardiovascular risk factors (including MI or stroke within 6 months; unstable angina; symptomatic peripheral artery disease etc) are excluded(iv) Pregnant women and patients with immune deficiency are also excluded.
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Interventions
CYT997 administered as a 24 hour intravenous infusion every three weeks
CYT997 administered as a 24 hour intravenous infusion every three weeks
Locations(1)
View Full Details on ANZCTR
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ACTRN12605000793617