A Randomized Phase 2 Trial of Doxorubicin plus Pemetrexed followed by Docetaxel, versus Doxorubicin plus Cyclophosphamide followed by Docetaxel, as Neoadjuvant Treatment for Early Breast Cancer The primary objective of the study is to assess the antitumor activity, as measured by the pathologic complete response (pCR) rate in the breast, of neoadjuvant treatment with two different sequential...

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A Phase 2 Double-Blind Randomized Study of Oral Enzastaurin HCl versus Placebo Concurrently with Pemetrexed (Alimta®) as Second Line Therapy in Patients with Advanced or Metastatic Non Small Cell Lung Cancer To compare pemetrexed plus enzastaurin when given in a twice daily dosing schedule versus pemetrexed plus placebo twice daily in terms of the progression-free survival time (PFS) of patients receiving...

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A Phase 2 Clinical Study to Evaluate Daily Oral Doses of LY500307 for 24 weeks in Men with Lower Urinary Tract Symptoms (LUTS) and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia (BPH) To compare the effect of LY500307 once daily for 24 weeks versus placebo treatment in improving the IPSS in men with LUTS and prostatic enlargement secondary to BPH.

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The Effect of Teriparatide Compared with Risedronate on Back Pain in Postmenopausal Women with Osteoporotic Vertebral Fractures to compare the efficacy of teriparatide 20 µg/day versus risedronate 35 mg/week on the reduction of back pain in postmenopausal women with prevalent osteoporotic vertebral fractures associated with ch...

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A Randomized Phase 2 Study Comparing Erlotinib-Pemetrexed, Pemetrexed alone, and Erlotinib alone, as Second-Line Treatment for Non-Smoker Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer To compare an erlotinib-pemetrexed combination with pemetrexed alone, and erlotinib alone, in terms of progression-free survival (PFS) in non-smoker patients with locally advanced or metastatic (Stage...

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A Single-Arm, Phase 2 Trial of Pemetrexed, Cisplatin, and Bevacizumab as Induction, Followed by Pemetrexed and Bevacizumab as Maintenance, in First-Line Treatment of Nonsquamous Advanced NSCLC The primary objective of this Phase 2 study is to assess the efficacy of pemetrexed-cisplatin combined with bevacizumab as induction therapy and pemetrexed-bevacizumab as maintenance therapy in the fi...

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A Phase 3, Open-Label, Parallel-Group Study to Compare Two Dosing Algorithms for Preprandial Human Insulin Inhalation Powder (HIIP) in Insulin-Naïve Patients with Type 2 Diabetes Mellitus The primary objective of this study, in suboptimally-controlled insulin-naïve individuals with type 2 diabetes, is to demonstrate that a simple approach for adding HIIP to oral antihyperglycemic medic...

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An Open Label, Multicenter Phase 2 Study of Single-Agent Enzastaurin HCl in Previously Treated Waldenstrom’s Macroglobulinemia or Multiple Myeloma To determine whether further study of single-agent enzastaurin is warranted in patients with previously treated WM or MM, based on RR.

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A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed plus Best Supportive Care versus Best Supportive Care Immediately Following Induction Treatment with Pemetrexed + Cisplatin for Advanced Non-Squamous Non Small Cell Lung Cancer The primary objective of this study is to compare maintenance therapy with pemetrexed plus best supportive care (BSC) versus placebo plus BSC, in terms of objective progression-free survival (PFS) tim...

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A Randomized, Phase 2, Placebo-Controlled, Double-Blinded Study With and Without Enzastaurin in Combination With Paclitaxel and Carboplatin as First-Line Treatment, Followed by Maintenance Treatment in Advanced Ovarian Cancer Compare the antitumor activity in first-line therapy of paclitaxel- and carboplatin-combination therapy plus enzastaurin followed by enzastaurin maintenance therapy (Regimen A), versus paclitaxel- and...

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