A Phase II Study of AS1411 in Renal Cell Carcinoma - Full Text View

Sponsored by:	Antisoma Research
Information provided by:	Antisoma Research
ClinicalTrials.gov Identifier:	NCT00740441

Purpose

The aim of this study is to evaluate the efficacy of AS1411 in patients with Metastatic Renal Cell Carcinoma

Condition	Intervention	Phase
Metastatic Renal Cell Carcinoma	Drug: AS1411	Phase II

MedlinePlus related topics: Cancer

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study
Official Title:	A Phase II, Open Label, Single Arm Study of AS1411 in Patients With Metastatic Renal Cell Carcinoma

Further study details as provided by Antisoma Research:

Primary Outcome Measures:

To determine the Overall Response Rate to AS1411 [ Designated as safety issue: No ]

Secondary Outcome Measures:

To measure progression free survival with AS1411 [ Designated as safety issue: No ]
To measure time to disease progression with AS1411 [ Designated as safety issue: No ]
To measure the duration of overall response and stable disease with AS1411 [ Designated as safety issue: No ]
To determine the safety and tolerability of two cycles of AS1411 [ Designated as safety issue: Yes ]
To assess the pharmacokinetic profile of AS1411 [ Designated as safety issue: No ]
To assess pharmacodynamic markers of AS1411 [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	August 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental AS1411 treatment	Drug: AS1411 AS1411 40 mg/kg/day) will be administered on days 1-4 via a continuous iv infusion every 28-day cycle for up to 2 cycles

Eligibility

Criteria

Inclusion Criteria:

Histologically or cytologically confirmed renal cell carcinoma containing predominant clear cell histology
Failed or intolerant to 1 or more previous lines of treatments (which must include a Tyrosine Kinase Inhibitor)

Exclusion Criteria:

Collecting duct histology
A history of bleeding disorders or currently taking oral vitamin K antagonise medication
Unstable brain metastases
History of prior or concomitant malignancy (except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix, or other cancer for which the patient has been disease free for 3 years)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740441

Contacts

Contact: Chris Smyth, PhD

+44 20 3249 2100

Locations

United States, Indiana
St Francis Hospital	Recruiting
Beech Grove, Indiana, United States, 46107
Contact: Cathy Spears 317-782-7819
Principal Investigator: Greg Smith, MD
United States, Kentucky
James Graham Brown Cancer Center, University of Louisville	Recruiting
Louisville, Kentucky, United States, 40202
Contact: Beverly Taft 502-562-3465 bstaft01@gwise.louisville.edu
Contact: Stacy Baum 502-562-2280 msbaum02@louisville.edu
Principal Investigator: Damian Laber, MD
United States, Massachusetts
Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Angela Qu 617-632-2936 angela_qu@dfci.harvard.edu
Principal Investigator: Toni Choueiri, MD
United States, South Carolina
Medical University of South Carolina	Recruiting
Charleston, South Carolina, United States, 29403
Contact: Allen Brisendine 843-792-9007
Principal Investigator: Harry Drabkin, MD

Sponsors and Collaborators

Antisoma Research

Investigators

Principal Investigator:	Greg Smith, MD	Saint Francis Memorial Hospital
Principal Investigator:	Harry Drabkin, MD	Medical University of South Carolina

More Information

Responsible Party:	Antisoma ( Chris Smyth )
Study ID Numbers:	AS1411-C-202
Study First Received:	August 22, 2008
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00740441
Health Authority:	United States: Food and Drug Administration

Keywords provided by Antisoma Research:

renal cell carcinoma
rcc
kidney cancer

Study placed in the following topic categories:

Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Urogenital Neoplasms
Renal cancer
Kidney Diseases

Kidney cancer
Urologic Neoplasms
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009