Overview

This trial is active, not recruiting.

Condition metastatic renal cell carcinoma
Treatment as1411
Phase phase 2
Sponsor Antisoma Research
Start date August 2008
End date September 2009
Trial size 30 participants
Trial identifier NCT00740441, AS1411-C-202

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
AS1411 treatment
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

Primary Outcomes

Measure
To determine the Overall Response Rate to AS1411
time frame:

Secondary Outcomes

Measure
To measure progression free survival with AS1411
time frame:
To measure time to disease progression with AS1411
time frame:
To measure the duration of overall response and stable disease with AS1411
time frame:
To determine the safety and tolerability of two cycles of AS1411
time frame:
To assess the pharmacokinetic profile of AS1411
time frame:
To assess pharmacodynamic markers of AS1411
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title A Phase II, Open Label, Single Arm Study of AS1411 in Patients With Metastatic Renal Cell Carcinoma
Principal investigator Greg Smith, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2009.
Information provided to ClinicalTrials.gov by Antisoma Research.