A Phase II Study of AS1411 in Renal Cell Carcinoma

Metastatic Renal Cell Carcinoma Clinical Trial

Official title:

A Phase II, Open Label, Single Arm Study of AS1411 in Patients With Metastatic Renal Cell Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00740441
• Other study ID #: AS1411-C-202
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 22, 2008
• Last updated: September 24, 2009
• Start date: August 2008
• Est. completion date: March 2010

Study information

• Verified date: September 2009
• Source: Antisoma Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: March 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Metastatic Renal Cell Carcinoma

Intervention

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

Locations

Country	Name	City	State
United States	St Francis Hospital	Beech Grove	Indiana
United States	Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	City of Hope	Duarte	California
United States	James Graham Brown Cancer Center, University of Louisville	Louisville	Kentucky
United States	University of California, Davis Cancer Center	Sacramento	California
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Antisoma Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the Overall Response Rate to AS1411			No
Secondary	To measure progression free survival with AS1411			No
Secondary	To measure time to disease progression with AS1411			No
Secondary	To measure the duration of overall response and stable disease with AS1411			No
Secondary	To determine the safety and tolerability of two cycles of AS1411			Yes
Secondary	To assess the pharmacokinetic profile of AS1411			No
Secondary	To assess pharmacodynamic markers of AS1411			No