Description Module

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Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module

Ignite Creation Date: 2025-12-25 @ 2:09 AM
Ignite Modification Date: 2025-12-25 @ 2:09 AM
NCT ID: NCT01016860
Brief Summary: This study plans to learn more about an investigational drug called OSI-906. OSI-906 is being looked at to see if it could be a treatment for advanced cancer. "The FDA is the U.S. government agency that reviews the results of research of drugs and decides if it can be sold in the U.S. OSI-906 has been given to over 185 people with cancer.
Detailed Description: This study plans to learn more about an investigational drug called OSI-906. OSI-906 is being looked at to see if it could be a treatment for advanced cancer. Subjects will also receive a drug called irinotecan (also called Camptosar®). This drug is FDA approved for the treatment of metastatic colon cancer and some other types of cancer. The study drug and irinotecan have never been tested together in humans. It is unknown if the combination will be safe and/or effective in the treatment of human cancers. The purpose of this study is to find the answers to the following research questions: * What is the highest dose of the study drug that can be given to subjects in combination with irinotecan without causing side effects that are too severe? * How is the combination of the study drug and irinotecan handled in the blood of subjects with advanced cancer? Does either the study drug or irinotecan have an effect on how the other works? * What are the most common side effects of the study drug and irinotecan when given together to subjects with advanced cancer? * Is the combination of the study drug and irinotecan effective in stopping the growth or shrinking the size of your tumor?
Study: NCT01016860
Study Brief:
Protocol Section: NCT01016860