Colorectal Cancer Clinical Trial
Official title:
A Phase I/IB Study of OSI-906 and Irinotecan in Patients With Advanced Cancer With Expanded Cohorts of Patients With Colorectal Cancer Stratified by the OSI-906 Integrated Classifier
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.
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?
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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