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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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Open Label Study of AS1411 in Advanced Solid Tumours

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the pharmacokinetic (PK) distribution and profile of AS1411 [ Designated as safety issue: No ]
  • To obtain preliminary evidence of clinical and biological responses to AS1411 [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013