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Latest New Medical Therapy Results
Following are the most recent results for new drug therapies currently in clinical trials worldwide. Results
are also searchable by therapeutic area beginning with the most recent updates.
AB Science released results from a phase II trial of masitinib for the treatment of Gleevec-resistant gastrointestinal stromal tumors. The study enrolled 44 subjects with inoperable, locally advanced or metastatic GIST who had disease progression while treated with Gleevec. The subjects received either masitinib at 12 mg/kg/day or Sutent (sunitinib) until progression. After a median follow-up of 14 months, median overall survival was not reached for masitinib versus 15 months for Sutent (p≡0.022). After 18 months, 79% of subjects treated with masitinib were still alive, versus 20% for subjects treated with Sutent. After 2 years, 53% of subjects treated with masitinib were still alive, versus 0% for the subjects treated with Sutent. Masitinib was also significantly better tolerated than Sutent and had a better safety profile.
BTG International reported results from a phase II trial of Varisolve microfoam for the treatment of varicose veins. This randomized, blinded trial, VANISH-2, enrolled 235 subjects with symptomatic and visible varicose veins and saphenofemoral junction incompetence who were randomized to treatment with one of three dose concentrations (0.125%, 0.5% or 1.0%) of Varisolve microfoam or placebo. The primary endpoint was an improvement in symptoms recorded using a patient-reported outcomes instrument, VVSymQ at eight weeks following treatment. The 0.5% and 1.0% dose concentrations of Varisolve microfoam demonstrated a statistically significant improvement in symptoms compared to placebo (p<0.0001). The subjects treated with Varisolve microfoam 0.5 and 1.0% also reported a statistically significant improvement in compared with placebo (p<0.0001 and p<0.0001, respectively). There were no serious or unexpected adverse events.
Medivation issued results from a phase III trial of MDV3100 for the treatment of prostate cancer. This placebo-controlled, double-blind, multinational trial, dubbed AFFIRM, enrolled 1,199 subjects with metastatic castration-resistant prostate cancer who had failed docetaxel-based chemotherapy. The subjects received MDV3100 160 mg orally once daily or placebo. The primary endpoint was overall survival. Data demonstrated a statistically significant improvement in overall survival compared to placebo (p<0.0001). The median survival for the MDV3100 arm was 18.4 months compared with 13.6 months for the placebo arm. MDV3100 also met all secondary endpoints, including radiographic progression-free survival (8.3 versus 2.9 months; p<0.0001), soft tissue response rate (28.9% versus 3.8%; p<0.0001) and time to prostate-specific antigen (PSA) progression (8.3 versus 3.0 months; p<0.0001).
