- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00881244
Study of AS1411 in Advanced Solid Tumours
April 14, 2009 updated by: Antisoma Research
Phase I Open Label 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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Kentucky
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Louisville, Kentucky, United States, 40202
- James Graham Brown Cancer Center, University of Louisville
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
AS1411
|
I.v. 4-7 days, 1-40 mg/kg/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of AS1411
|
Secondary Outcome Measures
Outcome Measure |
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To determine the pharmacokinetic (PK) distribution and profile of AS1411
|
To obtain preliminary evidence of clinical and biological responses to AS1411
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2003
Primary Completion (ACTUAL)
June 1, 2006
Study Completion (ACTUAL)
February 1, 2007
Study Registration Dates
First Submitted
April 14, 2009
First Submitted That Met QC Criteria
April 14, 2009
First Posted (ESTIMATE)
April 15, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
April 15, 2009
Last Update Submitted That Met QC Criteria
April 14, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AS1411-C-101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Advanced Solid Tumors
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AmgenCompletedCancer | Advanced Solid Tumors | Solid Tumors | Tumors | Advanced MalignancyUnited States, Australia
-
NantCell, Inc.CompletedQUILT-2.016: Study of AMG 479 With Biologics or Chemotherapy for Subjects With Advanced Solid TumorsCancer | Advanced Solid Tumors | Solid Tumors | Tumors | Advanced Malignancy
-
Incyte CorporationRecruitingA Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid TumorsAdvanced Solid Tumors | Solid Tumors | Metastatic Solid TumorsUnited States, Spain, United Kingdom, France, Italy, Denmark, Switzerland
-
Hoffmann-La RocheCompletedSolid Tumors, Advanced Solid TumorsUnited States
-
Esperance Pharmaceuticals IncCompletedAdvanced Solid Tumors | Solid TumorsUnited States
-
Incyte Biosciences Japan GKCompletedAdvanced Solid Tumors | Metastatic Solid TumorsJapan
-
Memorial Sloan Kettering Cancer CenterKyowa Hakko Kirin Pharma, Inc.CompletedAdvanced Solid Tumors | Metastatic Solid TumorsUnited States
-
Bristol-Myers SquibbCompletedAdvanced Solid Tumors | Metastatic Solid TumorsKorea, Republic of, Canada, Australia
-
Vividion Therapeutics, Inc.RecruitingAdvanced Solid Tumors | Advanced Hematologic TumorsUnited States, Australia
-
Millennium Pharmaceuticals, Inc.CompletedAdvanced Solid Tumors, Neoplasms, Advanced SolidHungary
Clinical Trials on AS1411
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Antisoma ResearchUnknown
-
Antisoma ResearchCompletedLeukemia, MyeloidUnited States, New Zealand
-
Antisoma ResearchTerminatedAcute Myeloid LeukemiaUnited States, Taiwan, Australia, New Zealand