NCT00881244

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2003

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2009

Completed
Last Updated

April 15, 2009

Status Verified

April 1, 2009

Enrollment Period

2.8 years

First QC Date

April 14, 2009

Last Update Submit

April 14, 2009

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

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

  • To obtain preliminary evidence of clinical and biological responses to AS1411

Study Arms (1)

1

EXPERIMENTAL

AS1411

Drug: AS1411

Interventions

AS1411DRUG

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

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

James Graham Brown Cancer Center, University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Interventions

AGRO 100

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 14, 2009

First Posted

April 15, 2009

Study Start

September 1, 2003

Primary Completion

June 1, 2006

Study Completion

February 1, 2007

Last Updated

April 15, 2009

Record last verified: 2009-04

Locations

US(1)