Study of AS1411 in Advanced Solid Tumours

Antisoma Research

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: AS1411

Study type: Interventional

Funder types: Industry

Identifiers

NCT00881244

AS1411-C-101

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with advanced solid tumours that were refractory to conventional/standard treatment
• Age >/ 18 years
• ECOG performance status </ 2 (Karnofsky >/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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

1

Experimental group

Description:

AS1411

Treatment:

Drug: AS1411