Study of AS1411 in Advanced Solid Tumours

Advanced Solid Tumors Clinical Trial

Official title:

Phase I Open Label Study of AS1411 in Advanced Solid Tumours

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00881244
• Other study ID #: AS1411-C-101
• Status: Completed
• Phase: Phase 1
• First received: April 14, 2009
• Last updated: April 14, 2009
• Start date: September 2003
• Est. completion date: February 2007

Study information

• Verified date: April 2009
• Source: Antisoma Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2007
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• AS1411
I.v. 4-7 days, 1-40 mg/kg/day

Locations

Country	Name	City	State
United States	James Graham Brown Cancer Center, University of Louisville	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Antisoma Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of AS1411			Yes
Secondary	To determine the pharmacokinetic (PK) distribution and profile of AS1411			No
Secondary	To obtain preliminary evidence of clinical and biological responses to AS1411			No