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OpenTrials
Completed

NCT Number: NCT00881244

Study of AS1411 in Advanced Solid Tumours

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.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

James Graham Brown Cancer Center, University of Louisville

Louisville, Kentucky, 40202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AS1411

Drug

I.v. 4-7 days, 1-40 mg/kg/day

Primary outcomes

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

Secondary outcomes

  1. To determine the pharmacokinetic (PK) distribution and profile of AS1411

  2. To obtain preliminary evidence of clinical and biological responses to AS1411

Sponsors and collaborators

Lead sponsor

Antisoma Research

Industry

Registry information

Official study title

Phase I Open Label Study of AS1411 in Advanced Solid Tumours

Important dates

Study start
2003
Primary completion
2006
Study completion
2007
First posted
Apr 15, 2009
Registry last updated
Apr 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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