In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 25, No. 18_suppl ( 2007-06-20), p. 7596-7596
Abstract:
7596 Background: OGX-011 is a second-generation antisense oligonucleotide designed to knockdown expression of the cytoprotective chaperone, clusterin, thereby facilitating apoptosis and sensitization of many human cancer cell-lines to chemotherapy. Methods: Eligibility criteria: stage IIIB/IV NSCLC; no prior chemotherapy; =1 measurable lesion; ECOG =1; adequate organ function; no active CNS metastasis. Treatment: infusion of OGX-011 initial loading doses (3 in 1 week), followed by weekly OGX-011 with standard chemotherapy: GEM (1,250 mg/m 2 ) Days 1+8 and either cisplatin (75 mg/m 2 ) or carboplatin (AUC=5) Day 1 q21 days, (maximum 6 cycles). Results: 85 pts (phase I=10 and phase II=75) enrolled between Dec 04 and Nov 06. Based on phase I results, dose of OGX-011 was 640 mg. Data is available on the first 53 pts; all received =1 dose of OGX-011 and were considered evaluable for safety and efficacy. Demographics: female (47%); stage IV (87%); median age 61 (45–79) yrs; ECOG PS =1 (62%); median no. of cycles delivered was 4. Principal grade 3/4 toxicities were hematologic: neutropenia (32%) + thrombocytopenia (17%). Other common toxicities included fatigue, nausea, vomiting, fever, chills, constipation, + anorexia. Two serious adverse events previously reported as associated with GEM/platinum therapy were documented: acute cortical blindness with stroke + thrombotic thrombocytopenic purpura. Responses: 12 confirmed PR (ORR = 23%). Median PFS is 101 days (53–260+). Of the first 24 patients who have all been followed for =1 yr, median survival is 383 days (19–751+); 14/24 (58%) survived 〉 1 yr; 10/14 remain alive as of 12/13/06. Conclusions: 1-yr survival rate =50% may justify a phase III randomized trial. Survival data on 46 pts followed for =1 yr will be presented. OGX-011 is being developed by OncoGenex Technology Inc. + Isis Pharmaceuticals Inc. No significant financial relationships to disclose.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2007.25.18_suppl.7596
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2007
detail.hit.zdb_id:
2005181-5
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