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January 29, 2007
BTG issued positive results from a phase I/II trial of plevitrexed for the treatment of metastatic gastric cancer. The phase I portion of this trial enrolled 30 subjects who received plevitrexed at doses of 65 mg/m2, 130 mg/m2 and 165 mg/m2 on days 1 and 8 of a 3-week cycle in combination with nutritional levels of folic acid and vitamin B12. This part of the trial was designed to evaluate the safety, tolerability and maximum tolerated dose (MTD) for the phase II portion, which enrolled an additional 25 subjects and was designed to evaluate efficacy. Treatment was well tolerated with no reported serious adverse events. The MTD was determined to be 130 mg/m2. Of the 28 subjects evaluable for efficacy at this dose level, five (17.9%) had partial response and 15 (53.6%) had stable disease, for an overall disease control rate of 71.4%. One subject treated with plevitrexed at a lower dose of 65 mg/m2 had a complete response and five subjects who received a higher dose of 165 mg/m2 had stable disease. The median progression free survival rate was 120 days and the median overall survival was 239 days. Based on these results, BTG plans to seek a partner to complete the clinical and commercial development of plevitrexed in the treatment of gastric and other types of cancer.
Taiho reported positive interim results from a phase III trial of S-1 for the treatment of gastric cancer. This trial, dubbed ACTS-GC, enrolled 1,059 subjects with stage II or III gastric cancer, in Japan. Subjects were randomized to receive oral S-1 for 12 months at 80-120 mg/day according to the body surface, (administration was 4 weeks on with 2 weeks off in each course, starting within 45 days of surgery until 1 year after surgery), versus curative surgery alone. The primary endpoint was overall survival. Secondary endpoints included relapse free survival and safety. Treatment was generally well tolerated, with the most common reported adverse events including nausea, vomiting and diarrhea. Overall survival at 3-years was 80.5% for subjects receiving S-1 and 70.1% for subjects undergoing surgery alone, with a hazard ratio (HR) of 0.68 (95%CI, 0.52-0.87, p=0.0024). The 3 year relapse free survival was 72.2% in the S-1 arm and 60.1% for surgery alone (p=0.0001) and the reduction of the relative risk of relapse with S-1 was 38% (p < 0.0001). Finally, the relative risk of death for the subjects in the S-1 arm was reduced by 32% as compared to curative surgery alone (p = 0.0024). This drug is currently undergoing phase III trials in the US.
November 13, 2006
Amgen issued positive results from a phase II trial of AMG706 for the treatment of gastrointestinal stromal tumors. This trial enrolled 138 subjects who received at least one oral dose of AMG 706 at 125 mg per day until disease progression or toxicity. The primary endpoint of the trial was objective response per RECIST criteria. Secondary endpoints included an assessment of AMG706 on duration of response, progression-free survival, time to progression, survival and adverse events. The RECIST assessment showed a clinical benefit rate of 27% (3% partial response plus 24% durable stable disease greater than or equal to 22 weeks). The median progression-free survival was 16 weeks, with 26 week progression-free survival of 27%. Median survival was 59 weeks. Treatment was generally well tolerated with the most commonly reported adverse events including diarrhea, hypertension, fatigue and headache. Based on these results Amgen plans to move forward with the development of AMG706.
August 5, 2002
Interim results of a phase II trial of Aphton's G17DT in combination with chemotherapy showed that out of 72 subjects with metastatic stomach cancer who were treated with the investigational drug, 36 had tumor shrinkage of 50% or more, and one subject had a complete tumor response (no detectable residual tumor). The overall tumor response rate was 51.4%. 20 additional subjects had stable disease.