A Phase II Study of AS1411 in Renal Cell Carcinoma

NCT ID: NCT00740441

Last Updated: 2009-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-03-31

Brief Summary

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

Detailed Description

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Conditions

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Metastatic Renal Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

AS1411 treatment

Group Type EXPERIMENTAL

AS1411

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Antisoma Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Antisoma

Principal Investigators

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Greg Smith, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Francis Hospital

Harry Drabkin, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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City of Hope

Duarte, California, United States

Site Status

University of California, Davis Cancer Center

Sacramento, California, United States

Site Status

University of California San Francisco

San Francisco, California, United States

Site Status

St Francis Hospital

Beech Grove, Indiana, United States

Site Status

James Graham Brown Cancer Center, University of Louisville

Louisville, Kentucky, United States

Site Status

Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

References

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Rosenberg JE, Bambury RM, Van Allen EM, Drabkin HA, Lara PN Jr, Harzstark AL, Wagle N, Figlin RA, Smith GW, Garraway LA, Choueiri T, Erlandsson F, Laber DA. A phase II trial of AS1411 (a novel nucleolin-targeted DNA aptamer) in metastatic renal cell carcinoma. Invest New Drugs. 2014 Feb;32(1):178-87. doi: 10.1007/s10637-013-0045-6. Epub 2013 Nov 16.

Reference Type DERIVED
PMID: 24242861 (View on PubMed)

Other Identifiers

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AS1411-C-202

Identifier Type: -

Identifier Source: org_study_id

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