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• W2024593618 abstract "The clusterin gene is frequently expressed in NSCLC and encodes a cytoprotective chaperone protein that is upregulated in response to apoptotic stimuli such as chemotherapy. OGX-011 is a second-generation antisense oligonucleotide that inhibits clusterin expression, thus enhancing the apoptotic effects of chemotherapy. Previous phase I studies with docetaxel suggested an OGX-011 dose of 640mg was feasible and biologically active; therefore, the current study began with a run-in phase with 480mg of OGX-011. Eligibility criteria: stage IIIB/IV NSCLC; no prior chemotherapy; ? 1 measurable lesion; ECOG ?1; adequate organ function; no active CNS metastasis. Treatment: OGX-011 is given as a 2-hour infusion. There is an initial loading phase with 3 doses of OGX-011 alone in 1 week, followed by weekly OGX-011 with standard chemotherapy: gemcitabine (1250 mg/m2) Days 1+8 and either cisplatin (75 mg/m2) or carboplatin (AUC=5) Day 1 q21 days, (maximum 6 cycles). 85 pts (phase 1=10 and phase 2=75) were enrolled between Dec, 2004 and Nov, 2006. As no unexpected dose limiting toxicities were noted in the first 3 patients who received 480mg of OGX-011, the dose was escalated, as planned, to 640 mg for the remaining patients. Data are 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%). The median number 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 gemcitabine/platinum therapy were documented: acute cortical blindness with stroke + thrombotic thrombocytopenic purpura. Responses: confirmed PRs 13 (ORR = 24%); median duration of PR: 105 days (46-336+); median PFS: 140 days (2-422+); 79% of pts have progressed; 47% have died. Of the first 34 patients who have all been followed for ? 1 yr, 18/34 (53%) survived > 1 yr; 14/18 (78%) remain alive as of March 06, 2006. Data will be presented for all 85 patients. This combination is feasible and tolerable. The 1-yr survival rate ?50% may justify a randomized phase III trial. OGX-011 is being developed by OncoGenex Technology Inc. + Isis Pharmaceuticals Inc." @default.
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• W2024593618 date "2007-08-01" @default.
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• W2024593618 title "B1-02: A Phase 1-2 study of the anti-sense oligonucleotide OGX-011 in combination with a platinum/gemcitabine regimen as first-line therapy for advanced non-small cell lung cancer" @default.
• W2024593618 doi "https://doi.org/10.1097/01.jto.0000283140.60799.58" @default.
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