Overview

Study of AS1411 in Advanced Solid Tumours

Status:
Completed
Trial end date:
2007-02-01
Target enrollment:
0
Participant gender:
All
Summary
A Phase I open label study of AS1411 in advanced solid tumours. Objectives include determining the MTD and DLT of AS1411, to determine the PK profile of AS1411 and to obtain preliminary evidence of clinical and biological responses to AS1411 therapy.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Antisoma Research
Criteria
Inclusion Criteria:

- Patients with advanced solid tumours that were refractory to conventional/standard
treatment

- Age >/ 18 years

- ECOG performance status /60%

- Life expectancy >/ 8 weeks

- Adequate organ and marrow function

Exclusion Criteria:

- Radiotherapy or chemotherapy in the 4 weeks before study entry (6 weeks for
nitrosourea or mitomycin C

- Lack of recovery from adverse events (AEs) caused by agents administered before study
entry; current use of other investigational agent(s)

- Uncontrolled brain metastases including a need for corticosteroid therapy

- Pregnancy

- Uncontrolled intercurrent illness

- Psychiatric illness/social situations that could limit compliance