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Study of AS1411 in Advanced Solid Tumours

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ClinicalTrials.gov Identifier: NCT00881244
Recruitment Status : Completed
First Posted : April 15, 2009
Last Update Posted : April 15, 2009
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: AS1411 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Open Label Study of AS1411 in Advanced Solid Tumours
Study Start Date : September 2003
Primary Completion Date : June 2006
Study Completion Date : February 2007
Arms and Interventions

Arm Intervention/treatment
Experimental: 1
AS1411
Drug: AS1411
I.v. 4-7 days, 1-40 mg/kg/day


Outcome Measures

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

Secondary Outcome Measures :
  1. To determine the pharmacokinetic (PK) distribution and profile of AS1411
  2. To obtain preliminary evidence of clinical and biological responses to AS1411

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00881244


Locations
United States, Kentucky
James Graham Brown Cancer Center, University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
Antisoma Research
More Information

Responsible Party: Chris Smyth, VP Clinical Operations, Antisoma
ClinicalTrials.gov Identifier: NCT00881244     History of Changes
Other Study ID Numbers: AS1411-C-101
First Posted: April 15, 2009    Key Record Dates
Last Update Posted: April 15, 2009
Last Verified: April 2009