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Phase I Open Label Study of AS1411 in Advanced Solid Tumours


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors

Thank you

Trial Information

Phase I Open Label Study of AS1411 in Advanced Solid Tumours


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of AS1411

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

AS1411-C-101

NCT ID:

NCT00881244

Start Date:

September 2003

Completion Date:

February 2007

Related Keywords:

  • Advanced Solid Tumors
  • Neoplasms

Name

Location

James Graham Brown Cancer Center, University of LouisvilleLouisville, Kentucky  40202