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Keck Medicine of USC is the University of Southern California’s medical enterprise, one of only two university-owned academic medical centers in the Los Angeles area.
Listing Page2019-02-06T14:57:24+00:00

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Specific to Search

ID
413
NCTID
NCT02038647
2O-14-1 A Randomized, Double-blind, Placebo-controlled, Phase 2 Clinical Trial of Alisertib (MLN8237) in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel as Second Line Therapy for Small Cell Lung Cancer (SCLC)

Type: Lung Cancer

Description

Small cell lung cancer (SCLC) accounts for about 13 to 15% of all lung cancers diagnosed, representing around 30,000 new cases in the US each year. This is a devastating disease where patients are rarely cured and the long-term survival beyond 5 years is less than 5%. Despite efforts to test new therapies and treatment strategies, improvements in outcomes for SCLC over the past 25 years have been very limited and there is an urgent need to find effective new therapies. Alisertib (MLN8237) is a small-molecule inhibitor of Aurora A kinase, a protein in the body essential for cell growth, and is being developed for the treatment of advanced cancers. Paclitaxel is an agent that disrupts cell division, which results in eventual cell death. Previous studies have demonstrated antitumor activity when combining Aurora kinase inhibitors with paclitaxel in a variety of solid tumor and blood cancer models. This study is a phase 2 study designed to evaluate the effectiveness and safety of the combination of alisertib + paclitaxel compared with placebo + paclitaxel in patients with SCLC whose cancer has returned or who did not respond to first line standard therapy. The primary objective is to determine if the combination treatment of alisertib + paclitaxel can improve the time that the disease worsens when compared with placebo + paclitaxel.\n\nOnce participants sign the informed consent and are deemed eligible for the study, participants will be randomized to receive either alisertib + paclitaxel or placebo + paclitaxel . During the study, participants in both groups will have the study procedures listed in the protocol done during each cycle. All participants will stop taking study drug(s) if their disease worsens, they start another treatment for their disease, they cannot tolerate the side effects, they withdraw from the study, they are lost to follow up, they do not follow instructions, or the study sponsor stops the study. All participants will be followed for 30 days after stopping the study drug(s), then every 2 months until death. \n\nIn general, summary tables will be presented that will display the number of observations, mean, standard deviation, median, minimum, and maximum for continuous variables, and the number and percentage per category for categorical data. The Kaplan-Meier survival curves and 25th, 50th (median), and 75th percentiles will be provided, along with associated 2-sided 95% confidence intervals (CIs) for time-to-event data

ID
413
NCTID
NCT02038647
2O-14-1 A Randomized, Double-blind, Placebo-controlled, Phase 2 Clinical Trial of Alisertib (MLN8237) in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel as Second Line Therapy for Small Cell Lung Cancer (SCLC)

Type: Lung Cancer

Description

Small cell lung cancer (SCLC) accounts for about 13 to 15% of all lung cancers diagnosed, representing around 30,000 new cases in the US each year. This is a devastating disease where patients are rarely cured and the long-term survival beyond 5 years is less than 5%. Despite efforts to test new therapies and treatment strategies, improvements in outcomes for SCLC over the past 25 years have been very limited and there is an urgent need to find effective new therapies. Alisertib (MLN8237) is a small-molecule inhibitor of Aurora A kinase, a protein in the body essential for cell growth, and is being developed for the treatment of advanced cancers. Paclitaxel is an agent that disrupts cell division, which results in eventual cell death. Previous studies have demonstrated antitumor activity when combining Aurora kinase inhibitors with paclitaxel in a variety of solid tumor and blood cancer models. This study is a phase 2 study designed to evaluate the effectiveness and safety of the combination of alisertib + paclitaxel compared with placebo + paclitaxel in patients with SCLC whose cancer has returned or who did not respond to first line standard therapy. The primary objective is to determine if the combination treatment of alisertib + paclitaxel can improve the time that the disease worsens when compared with placebo + paclitaxel.\n\nOnce participants sign the informed consent and are deemed eligible for the study, participants will be randomized to receive either alisertib + paclitaxel or placebo + paclitaxel . During the study, participants in both groups will have the study procedures listed in the protocol done during each cycle. All participants will stop taking study drug(s) if their disease worsens, they start another treatment for their disease, they cannot tolerate the side effects, they withdraw from the study, they are lost to follow up, they do not follow instructions, or the study sponsor stops the study. All participants will be followed for 30 days after stopping the study drug(s), then every 2 months until death. \n\nIn general, summary tables will be presented that will display the number of observations, mean, standard deviation, median, minimum, and maximum for continuous variables, and the number and percentage per category for categorical data. The Kaplan-Meier survival curves and 25th, 50th (median), and 75th percentiles will be provided, along with associated 2-sided 95% confidence intervals (CIs) for time-to-event data

ID
413
NCTID
NCT02038647
2O-14-1 A Randomized, Double-blind, Placebo-controlled, Phase 2 Clinical Trial of Alisertib (MLN8237) in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel as Second Line Therapy for Small Cell Lung Cancer (SCLC)

Type: Lung Cancer

Description

Small cell lung cancer (SCLC) accounts for about 13 to 15% of all lung cancers diagnosed, representing around 30,000 new cases in the US each year. This is a devastating disease where patients are rarely cured and the long-term survival beyond 5 years is less than 5%. Despite efforts to test new therapies and treatment strategies, improvements in outcomes for SCLC over the past 25 years have been very limited and there is an urgent need to find effective new therapies. Alisertib (MLN8237) is a small-molecule inhibitor of Aurora A kinase, a protein in the body essential for cell growth, and is being developed for the treatment of advanced cancers. Paclitaxel is an agent that disrupts cell division, which results in eventual cell death. Previous studies have demonstrated antitumor activity when combining Aurora kinase inhibitors with paclitaxel in a variety of solid tumor and blood cancer models. This study is a phase 2 study designed to evaluate the effectiveness and safety of the combination of alisertib + paclitaxel compared with placebo + paclitaxel in patients with SCLC whose cancer has returned or who did not respond to first line standard therapy. The primary objective is to determine if the combination treatment of alisertib + paclitaxel can improve the time that the disease worsens when compared with placebo + paclitaxel.\n\nOnce participants sign the informed consent and are deemed eligible for the study, participants will be randomized to receive either alisertib + paclitaxel or placebo + paclitaxel . During the study, participants in both groups will have the study procedures listed in the protocol done during each cycle. All participants will stop taking study drug(s) if their disease worsens, they start another treatment for their disease, they cannot tolerate the side effects, they withdraw from the study, they are lost to follow up, they do not follow instructions, or the study sponsor stops the study. All participants will be followed for 30 days after stopping the study drug(s), then every 2 months until death. \n\nIn general, summary tables will be presented that will display the number of observations, mean, standard deviation, median, minimum, and maximum for continuous variables, and the number and percentage per category for categorical data. The Kaplan-Meier survival curves and 25th, 50th (median), and 75th percentiles will be provided, along with associated 2-sided 95% confidence intervals (CIs) for time-to-event data