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Study of AS1411 in Advanced Solid Tumours

This study has been completed.
Sponsor:
Information provided by:
Antisoma Research
ClinicalTrials.gov Identifier:
NCT00881244
First received: April 14, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose
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 Intervention Phase
Advanced Solid Tumors Drug: AS1411 Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by Antisoma Research:

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

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

Enrollment: 30
Study Start Date: September 2003
Study Completion Date: February 2007
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AS1411
Drug: AS1411
I.v. 4-7 days, 1-40 mg/kg/day

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: April 14, 2009
Last Updated: April 14, 2009

ClinicalTrials.gov processed this record on August 18, 2017