Session: Genitourinary Cancer
Type: General Poster Session
Time: Monday June 7, 1:00 PM to 5:00 PM
Location: S Hall A2
http://abstract.asco.org/AbstView_74_49790.html
A phase II, single-arm study of AS1411 in metastatic renal cell carcinoma (RCC).
Sub-category: Kidney Cancer
Category: Genitourinary Cancer
Meeting: 2010 ASCO Annual Meeting
Citation: J Clin Oncol 28:7s, 2010 (suppl; abstr 4590)
Abstract No: 4590
Attend this session at the ASCO Annual Meeting!
Session: Genitourinary Cancer
Type: General Poster Session
Time: Monday June 7, 1:00 PM to 5:00 PM
Location: S Hall A2
A phase II, single-arm study of AS1411 in metastatic renal cell carcinoma (RCC).
Sub-category: Kidney Cancer
Category: Genitourinary Cancer
Meeting: 2010 ASCO Annual Meeting
Citation: J Clin Oncol 28:7s, 2010 (suppl; abstr 4590)
Abstract No: 4590
Author(s): J. E. Rosenberg, H. A. Drabkin, P. Lara Jr., A. L. Harzstark, R. A. Figlin, G. W. Smith, F. Erlandsson, D. A. Laber; Dana-Farber Cancer Institute/Harvard Medical School, Boston, MA; Medical University of South Carolina, Charleston, SC; University of California, Davis, Sacramento, CA; University of California, San Francisco, San Francisco, CA; City of Hope, Duarte, CA; St. Francis Hospital, Beech Grove, IN; Antisoma Research Ltd., London, United Kingdom; James Graham Brown Cancer Center, University of Louisville, Louisville, KY
Abstract:
Background: AS1411 is a DNA aptamer that targets nucleolin. Although normally present in the nucleolus, nucleolin is overexpressed and shows localization to the plasma membrane in renal and other cancer cells. A dose-escalating phase I trial of AS1411 monotherapy reported 1 complete response (CR) and 1 partial response (PR) among 12 patients with advanced RCC. A randomized phase II trial in AML reported increased CR rates when AS1411 was added to high-dose cytarabine. Methods: This phase II single-arm study evaluated AS1411 monotherapy in patients with metastatic, predominantly clear cell, RCC who had failed, or shown intolerance to, =1 prior treatment, including a tyrosine kinase inhibitor. AS1411 was administered at 40 mg/kg/day CI days 1-4 of a 28 day cycle for 2 cycles. Response evaluation using RECIST occurred every 8 weeks from the start of therapy until disease progression (performed by investigators and by an independent radiologist). The primary endpoint was response rate (CR+PR); progression-free survival (PFS), duration of response, and safety were secondary endpoints. Pharmacokinetic (PK) analysis was performed. Results: 35 patients were enrolled and treated; the median no. prior therapies was 2 (range 1-7). 33 completed 2 cycles of treatment. Independent response assessment indicated 1 PR (3%) and 21 cases of stable disease (SD; 60%); investigator assessment indicated 1 PR (3%) and 12 SD (34%). The patient achieving a PR exhibited a decreased sum of unidimensional target lesion measurements of = 80%, and remains in PR at 5.9 months. Independently assessed median PFS was 3.9 months. No = grade 4 adverse events were recorded; fatigue and constipation were the most common grade 1-3 adverse events occurring in 29% and 34% of patients, respectively. No other toxicity was observed in more than 10% of patients. PK analysis demonstrated a median steady-state plasma concentration of 21 µg/mL, which is similar to the IC50 concentration identified for renal cancer cell lines in vitro. Conclusions: AS1411 has activity in RCC with minimal toxicity; PFS was comparable to that seen with active agents in the refractory setting. Further studies are needed to determine the optimal dosing and scheduling for this novel therapeutic.
Recent ASM News
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 02/28/2024 11:45:24 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 11/08/2023 10:06:09 PM
- Form SUPPL - Voluntary Supplemental Material by Foreign Issuers [Section 11(a)] • Edgar (US Regulatory) • 10/30/2023 10:30:20 AM
- AVINO ANNOUNCES Q2 2023 PRODUCTION RESULTS • PR Newswire (Canada) • 07/20/2023 10:45:00 AM
- AVINO ANNOUNCES Q2 2023 PRODUCTION RESULTS • PR Newswire (US) • 07/20/2023 10:45:00 AM
- AVINO DRILLS BEST INTERCEPT IN COMPANY HISTORY • PR Newswire (US) • 07/05/2023 10:45:00 AM
- AVINO DRILLS BEST INTERCEPT IN COMPANY HISTORY • PR Newswire (Canada) • 07/05/2023 10:45:00 AM
- AVINO RENEWS US ATM SHARE OFFERING • PR Newswire (Canada) • 06/21/2023 09:24:00 PM
- AVINO RENEWS US ATM SHARE OFFERING • PR Newswire (US) • 06/21/2023 09:24:00 PM
- AVINO REPORTS VOTING RESULTS OF ITS 2023 ANNUAL GENERAL MEETING AND APPOINTS NEW DIRECTOR • PR Newswire (Canada) • 06/20/2023 11:18:00 PM
- AVINO REPORTS VOTING RESULTS OF ITS 2023 ANNUAL GENERAL MEETING AND APPOINTS NEW DIRECTOR • PR Newswire (US) • 06/20/2023 11:18:00 PM
- AVINO VEIN EXTENDED A FURTHER 500 METRES • PR Newswire (US) • 05/23/2023 07:45:00 AM
- AVINO VEIN EXTENDED A FURTHER 500 METRES • PR Newswire (Canada) • 05/23/2023 07:45:00 AM
- Avino Reports Q1 2023 Financial Results; Realizes Numerous Operational Achievements • PR Newswire (US) • 05/10/2023 09:48:00 PM
- Avino Reports Q1 2023 Financial Results; Realizes Numerous Operational Achievements • PR Newswire (Canada) • 05/10/2023 09:48:00 PM
NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • NNVC • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
Avant Technologies Names New CEO Following Acquisition of Healthcare Technology and Data Integration Firm • AVAI • May 2, 2024 8:00 AM
Bantec Engaged in a Letter of Intent to Acquire a Small New Jersey Based Manufacturing Company • BANT • May 1, 2024 10:00 AM
Cannabix Technologies to Deliver Breath Logix Alcohol Screening Device to Australia • BLO • Apr 30, 2024 8:53 AM
Hydromer, Inc. Reports Preliminary Unaudited Financial Results for First Quarter 2024 • HYDI • Apr 29, 2024 9:10 AM