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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000793617

Enrollment

Registered

2005-12-16

Start date

2005-06-14

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

CYT997 administered as a 24 hour intravenous infusion every three weeks

Study design

Allocation

Non-randomised trial

Intervention model

Other

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

(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 criteria

(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.

Outcome results